Cancer & Tumor Markers Catalog

Cancer & Tumor Markers Reagents for Assay Development ISO Certified

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Cancer Diagnostics

Cancer is a leading cause of death worldwide. More than half of all cancer deaths each year are due to lung, stomach, liver, colorectal and female breast cancers. If recent trends in major cancers continue globally in the future, the burden of cancer will increase by 68% over the next 15 years. The high cancer mortality rates are primarily due to a delayed detection of the disease and differences in the policies on cancer screening between countries.

Early detection is the key focus of cancer diagnostics and an early diagnosis makes it possible to cure the disease completely and/or increase survival rates. However, the financial burden associated with the cost of managing and treating cancer is a growing concern. Non-invasive techniques such as serum immunoassays detecting specific tumor markers are highly sought after in order to minimize the costs associated with screening and monitoring the disease. They provide fast, cost-effective, and accurate cancer detection while providing a valuable aid to the clinician and increased comfort to the patient. Cancer biomarkers (also called tumor markers) are proteins produced either by the tumor itself or by the body in response to the presence of cancer. They can be broadly classified into four groups: (1) screening and early detection, (2) diagnostic confirmation, (3) prognosis and prediction of therapeutic response, and (4) monitoring disease and recurrence. Over the past decade, an improved understanding of carcinogenesis and tumor progression has revealed a large number of potential tumor markers. Some markers are associated with only one type of cancer, whereas others are associated with two or more cancer types. No “universal” tumor marker that can detect any type of cancer has been discovered.

FDA Approved Biomarkers for Cancer

Thyroid Cancer (Tg)

Breast Cancer (CA15-3/MUC-1, CA27-29, CEA, erb.2/HER2/new)

Pancreatic Cancer (CA19-9, CEA)

Liver Cancer (AFP)

Colon Cancer (CEA)

Ovarian Cancer (CA125, HE4)

Prostate Cancer (PSA)

II | Cancer & Tumor Markers for Assay Development

Product Quickfind List

A Alpha 1 Acid Glycoprotein (AGP)........... 7 Alpha 1 Antichymotrypsin (ACT)............ 7 Alpha 1 Antitrypsin (A1AT)..................... 7 Alpha 2 HS Glycoprotein (AHSG)........... 7 Alpha 2 Macroglobulin (A2M)................ 8 Alpha Fetoprotein (AFP)......................... 8 Amylase.................................................. 8 Apolipoprotein CI (Apo CI). .................... 9 Apolipoprotein E (Apo E)........................ 9 B Beta 2 Microglobulin (B2M)................... 9 C Cadherin-E............................................ 10 Calcitonin.............................................. 10 Calprotectin L1..................................... 10 CA125................................................... 10 CA27.29................................................ 11 CA15-3/MUC1)..................................... 11 CA19-9.................................................. 11 CA50..................................................... 12 CA72-4 (TAG-72). ................................. 12 CA242................................................... 12 CEA....................................................... 12 Catalase................................................ 13 Cathepsin B.......................................... 13 Cathepsin D.......................................... 13 CD1d..................................................... 13 CD3....................................................... 13 CD4....................................................... 13 CD8....................................................... 13 CD9....................................................... 14 CD13 (Aminopeptidase N)................... 14 CD15..................................................... 14 CD19..................................................... 14 CD24..................................................... 14 CD28..................................................... 14 CD29 (Integrin beta-1).......................... 15 CD30..................................................... 15 CD37..................................................... 15 CD40..................................................... 15 CD42..................................................... 15 CD49d................................................... 15 CD49f (Integrin alpha-6)....................... 16 CD56 (NCAM)...................................... 16 CD57 .................................................... 16 CD59..................................................... 16 CD66b................................................... 16 CD71..................................................... 16 CD77..................................................... 17 CD90..................................................... 17 CD103................................................... 17 CD105 (Endoglin)................................. 17 CD147................................................... 17

CD152 (CTLA-1)................................... 17 CD177. ................................................. 17 CD195 (CCR5)...................................... 17 Centromere Protein B (CENPB)........... 18 Ceruloplasmin. ..................................... 18 c-Myc.................................................... 18 Collagen Type IV................................... 18 Collagen Type VI................................... 18 Cyfra 21-1............................................. 18 D Defensin-beta....................................... 19 Desmin................................................. 19 Desmocollin 3. ..................................... 19 Disialoganglioside GD2........................ 19 E Elastase................................................ 19 EGFR. ................................................... 19 erbB-2, HER2/neu................................ 20 EpCAM ................................................ 20 F Factor H (Beta 1H). .............................. 20 Factor VIII (FVIII)................................... 20 FGF-acidic............................................. 21 Fibronectin............................................ 21 G GAPDH ................................................ 21 Glypican-1 (GPC1)................................ 21 H Heat Shock Proteins. ........................... 22 Hemoglobin.......................................... 22 HE4....................................................... 22 5-Hydroxymethyluridine....................... 22 I IGF-I ..................................................... 23 IGFBP-3................................................ 23 Integrin alpha M (CD11b/MAC-1)........ 23 Interferon beta (IFN-beta). ................... 23 Interferon gamma (IFN-gamma).......... 23 IL-1a and IL-1R .................................... 24 K Kallikrein. .............................................. 24 L Lactate Dehydrogenase (LDH)............ 24 Lamin.................................................... 24 Leptin.................................................... 25 Lysozyme............................................. 25

M Microtubule Associated Protein 2 (MAP-2)................................................. 25 Mast Cell Tryptase (MCT).................... 25 Monocyte Chemotactic Protein 1 (MCP-1)................................. 25 N NGAL/Lipocalin-2. ................................ 25 NSE....................................................... 26 Non-Neuronal Enolase (NNE). ............. 26 O Osteopontin (OPN)............................... 26 P Pepsinogen I and Pepsinogen II ......... 26 PIVKA-II................................................. 27 Prolactin (PRL)...................................... 27 Prostate Secretory Protein (PSP)......... 27 PSA....................................................... 27 PSMA................................................... 28 Prostatic Acid Phosphatase (PAP)....... 29 R Retinol Binding Protein 4 (RBP4)......... 29 S S-100. ................................................... 29 Scramblase 1........................................ 29 Serum Amyloid A (SAA)....................... 30 Sialyl Lewis A and Sialyl Lewis X......... 30 Superoxide Dismutase (SOD).............. 30 T Thymus and Activation Regulated Chemokine (TARC)............................... 30 Thyroid Peroxidase (TPO). ................... 31 Thyroglobulin (Tg)................................. 31 Tissue Transglutaminase (tTG)............. 31 Trypsin. ................................................. 31 TNF-alpha . ........................................... 31 U Urokinase (uPA).................................... 32 V Vitronectin. ........................................... 32

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Company Overview

Meridian Life Science, Inc. is a leading large scale manufacturer of: • Antibodies • Viral antigens • Recombinant proteins • PCR enzymes • Nucleotides • Critical assay reagents Meridian has been providing innovative life science solutions and building trusted partnerships for over 40 years. Meridian’s focus is to offer products and services that help to advance the development of diagnostic assays and vaccine development. • Commercial scale manufacturing of antigens and antibodies with protein purification expertise • Full line of immunoassay reagents, including antigens, antibodies and blockers

• Large scale production of reagents for molecular assays • Technical support with assay development experience • Dedicated R&D and manufacturing teams • Robust and mature Quality System ISO certified

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Cancer & Tumor Markers - Reagents for Assay Development

Extensive Capabilities and Services Immunodiagnostics • Antigens & Antibodies • Recombinant Proteins • Blocking reagents Molecular Diagnostics • Nucleotides • enzymes • qPCR/PCR reagents • NGS reagents Contract Services • Antigens & Antibodies • Cell & Viral Banking • PCR/qPCR Assay Development

Global Presence MERIDIAN BIOSCIENCE, INC. Parent Company | Founded in 1977 | Nasdaq: VIVO Headquartered in Cincinnati, OH | 750+ Employees | Presence in 70+ Countries.

North America

EMEA

Asia Pacific

SYDNEY, AUSTRALIA Warehouse & Sales BEIJING, CHINA Wholly Owned Subsidiary

MEMPHIS, TN Viral Antigens Recombinant Proteins In Vitro Antibodies PCR Reagents BILLERICA, MA

LONDON, UK PCR Manufacturing & Sales PCR /qPCR Molecular Reagents LUCKENWALDE, GERMANY Large Scale Nucleotides PCR Enzymes Manufacturing PARIS, FRANCE EU Diagnostics Sales & Admin WATERLOO, BELGIUM EU Diagnostics Sales & Admin MILAN, ITALY EU Diagnostics Sales & Admin MODI’IN, ISRAEL BreathID ® Breath Test Systems

Magellan, Leadcare BOCA RATON, FL In Vivo Antibodies QUEBEC, CANADA GenePOC, Molecular Diagnostics

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Company Overview

• 3400+ products • High specificity & sensitivity • Antibody pairing • Large lot sizes

Antigens & Antibodies

Infectious disease

ToRCH • Toxo • Rubella • CMV

CHILDHOOD • Mumps • Rubeola • EBV • Coxsackie • Rotavirus • RSV • Parvo B19 • VZV RESPIRATORY • RSV

• HSV-1, 2 TROPICAL • Nipah • Dengue 1, 2, 3, 4

• Chikungunya • Mayaro Virus • Malaria • Chagas • Lassa Virus

GASTROINTESTINAL • Norovirus • Astrovirus • Adenovirus • Rotavirus •  Clostridium difficile

FOOD & WATER • Hepatitis A •  Campylobacter jejuni •  E. coli •  Legionella pneumophila •  Salmonella •  Shigella •  Bacillus anthracis •  Clostridium •  Listeria •  Streptococcus •  Staphylococcus •  Giardia lamblia •  Cryptosporidium

• Leishmaniasis • Leptospirosis • Newcastle disease • Yellow Fever • Zika • Lyme disease • Ebola STDs

• Influenza A,B • Parainfluenza •  Mycoplasma pneumoniae •  Chlamydia pneumoniae •  Legionella pneumophila •  Mycobacterium tuberculosis •  Streptococcus •  Staphylococcus • SARS Coronavirus • Adenovirus

•  Cryptosporidium •  Campylobacter •  E. coli •  Salmonella •  Giardia Iamblia •  H. pylori HEPATITIS

• HSV-1, 2 • HIV-1, 2 • HPV • Chlamydia • Neisseria • Syphilis

• HAV • HBV • HCV • HEV

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Cancer & Tumor Markers - Reagents for Assay Development

Cancer

Cardiac

• PIVKA-II • CA125 • CA15-3 • CA19-9 • CA72-4 • CA50 • CA242 • CEA • Cyfra 21-1 • erbB-2/HER2 • AFP

• EGFR • HE4 • NSE • P53 • PMA

• Troponin I, T • Myoglobin • BNP • NT-proBNP • CRP • PCT • CK-MB • Apo A,B,E • NSE • FABP • SAH • Galectin-3

• Cystatin-C • D-Dimer • MPO • Fibrinogen • EGF • sCD40L • CD54 • Lp-PLA2 • PAPP-A • Vitamin D • Renin

• PAP • PSA

• PSMA • S-100 • B2M • Thyroglobulin

Immunoglobulins/Blockers

Hormones

• TRU Block™ & IgM Diluent • Animal IgGs – Bovine, Chicken, Goat, Mouse, Rabbit, Sheep • Human IgA, IgG, IgM, IgE

• LH, FSH, hCG, hGH • AMH • Cortisol, Estradiol • Insulin, C-peptide • Prolactin • Progesterone • PTH

• PAPP-A • TSH, T4, T3, ACTH • Thyroglobulin

• Kappa Light chain • Lambda Light chain • Goat Anti-Human IgG, IgM, IgA • Goat Anti-Mouse IgG

Drugs of Abuse • Amphetamine • Barbital • Benzodiazepine • Buprenorphine

• Fentanyl • Ketamine • K2 • MDMA (Ecstasy) • Methadone • Methamphetamine • Morphine

• Norketamine • Opium • Oxycodone • PCP • Phenobarbital • Propoxyphene • THC

• Cocaine • Cotinine • EDDP

Autoimmune

Allergens

• Jo-1 • PCNA • pANCA • cANCA • Sm Ag • dsDNA

• Histone • GMB • C1q • ScI-70 • B2-Gly-1

• Animal • Dust Mite • Mold • Pollen

• Cathepsin G • Calprotectin

• La (SS-B) • Ro (SS-A)

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Leading Products

Antibodies & Matched Pairs

Alpha Fetoprotein (AFP) M86304M

Epidermal Growth Factor Receptor 2 (ERB2, HER2/NEU) M01296M

MAb (Capture) , ELISA MAb (Detection) , ELISA

M86641M

MAb, ELISA, reacts with peptide ILDV4 (dephosphorylated) MAb, ELISA, reacts with peptide ILDV4 (phosphorylated) MAb, ELISA, reacts with peptide ILDV2 (dephosphorylated) MAb, ELISA, reacts with peptide ILDV2 (phosphorylated)

* Not cross reactive with human albumin. MAM01-210 MAb (Capture) , ELISA MAM01-301 MAb (Detection) , ELISA

M01297M

M01298M

Beta 2 Microglobulin (B2M) MCP17-301 MAb, ELISA & RIA * Reacts with soluble B2M and B2M associated with cell-surface MHC Class I molecules and other membrane antigens. CA15-3 M86240M MAb (Capture) , ELISA M01288M MAb (Detection) , ELISA * Epitope is located within the VNTR tandem repeat region of MUC1 CA125 M86306M MAb Group A (Capture) , ELISA & WB M86924M MAb Group B (Detection) , ELISA & WB M86306M MAb Group A (Capture) , ELISA & WB M86429M MAb Group B (Detection) , ELISA & WB * Both pairs detect OC125 (Group A) and M11 (Group B). CA19-9 M66107M MAb (Capture) , ELISA M66106M MAb (Detection) , ELISA M66108M MAb (Alternate Detection) , ELISA M66106M MAb (Capture/Detection) , ELISA M66108M MAb (Capture/Detection) , ELISA * Abs can be used as capture or detection in a sandwich assay. M01335M MAb, ELISA CA72-4 M01341M MAb (Capture) , ELISA M01342M MAb (Alternate Capture) , ELISA M01340M MAb (Detection) , ELISA CEA

M01299M

HE4 M01323M M01320M M01323M M01321M

MAb (Capture) , ELISA MAb (Detection) , ELISA

MAb (Capture) , ELISA

MAb (Detection) , ELISA Human Hemoglobin (Fecal Occult Blood) H01348M MAb (Capture) , ELISA H01349M MAb (Detection) , ELISA H01416M MAb (Capture) , ELISA H01369M MAb (Detection) , ELISA H01409M MAb (Capture) , LF & Turbidimetry H01410M MAb (Detection) , LF & Turbidimetry Neuron Specific Enolase (NSE) M86101M MAb (Capture/Detection) , ELISA M86520M MAb (Capture/Detection) , ELISA * Abs can be used as capture or detection in a sandwich assay. Pepsinogen I K01402M MAb (Capture) , ELISA & LF K01403M MAb (Detection) , ELISA & LF K01406M MAb (Capture) , ELISA & LF K01407M MAb (Detection) , ELISA & LF Pepsinogen II K01404M MAb (Capture) , ELISA & LF K01405M MAb (Detection) , ELISA & LF

MAM02-008 MAb (Capture/Detection) , ELISA MAM02-009 MAb (Capture/Detection) , ELISA * Abs can be used as capture or detection in a sandwich assay.

PIVKA-II M01344M M01343M

MAb (Capture) , ELISA

MAM02-009 MAb (Capture) , ELISA MAM02-881 MAb (Detection) , ELISA M01250M

MAb (Detection) , ELISA Prostate Specific Antigen (PSA) Free M92986M MAb (Capture) , ELISA M92396M MAb (Detection) , ELISA * Not cross reactive to Albumin, AFP, CEA, PAP, CA125, CA19-9 or CA15-3. M86506M MAb (Capture/Detection) , ELISA & LF M86806M MAb (Capture/Detection) , ELISA & LF

MAb (Capture) , ELISA & IHC MAb (Detection) , ELISA & IHC

M01246M

* Specific for CEA epitope specificity group I.

Cyfra 21-1 (Cytokeratin 19) M01300M MAb, ELISA & WB M01326M MAb, ELISA

5 | Cancer & Tumor Markers for Assay Development Cancer & Tumor Markers - Reagents for Assay Development 5

Prostate Specific Antigen (PSA) Total M66276M MAb (Capture) , ELISA & LF M86506M MAb (Detection) , ELISA & LF * Specific for epitope 5 and not cross reactive with human kallikrein 2. M01236M MAb (Capture) , ELISA & LF M86506M MAb (Detection) , ELISA & LF Prostate Specific Membrane Antigen (PSMA) M20454M MAb, ELISA & IFA * Specific to the extracellular domain of PSMA.

S-100 Beta Q86006M

MAb (Capture) , ELISA MAb (Detection) , ELISA MAb (Capture) , ELISA

Q86610M Q86003M

Q86610M MAb (Detection) , ELISA * Each capture is specific for alpha-beta and each detection for alpha-beta and beta-beta. Thyroglobulin E01326M MAb (Capture) , ELISA E01325M MAb (Detection) , ELISA * Does not interfere with anti-thyroglobulin auto-antibodies.

Human Antigens (for use as standards, controls & calibrators)

Alpha Fetoprotein (AFP) A32260H

Neuron Specific Enolase (NSE) A86803H

Produced in cell culture, derived from a liver tumor cell and contains approximately 70% of the AFP-L3 isoform, ≥ 95% pure (SDS-PAGE & WB)

From human brain, > 95% pure (SDS-PAGE)

Pepsinogen II A01691H

Purified from human stomach, lyophilized, ≥ 90% pure (SDS-PAGE)

Beta 2 Microglobulin (B2M) A01412H

Pepsinogen II A01420H

From human urine, ≥ 98% pure (SDS-PAGE)

From human gastric mucosa, > 90% pure (SDS-PAGE) Purified from human stomach, lyophilized, ≥ 90% pure (SDS-PAGE) PSA, from human seminal fluid, lyophilized, > 95% pure (SDS-PAGE) PSA/ACT Complex, from human seminal fluid and plasma, > 95% pure (SDS-PAGE) PSA, From human seminal fluid, lyophilized, > 98% pure (SDS-PAGE)

CA15-3 A32231H CA125 A32180H CA19-9 A86199H A01458H CA72-4 A01723H CA50 A01264H CEA A32030H A38151H

Produced in cell culture, low cross reactivity

A01692H

Prostate Specific Antigen (PSA) A01368H

Produced in cell culture, low cross reactivity

From native human metastatic liver carcinoma Produced in cell culture, provided as cell culture concentrate

A31029H

A86878H

Produced in cell culture, low cross reactivity

Prostatic Acid Phosphatase (PAP) A01277H

From human seminal fluid, lyophilized > 96% pure

Produced in cell culture, provided as cell culture concentrate

S-100 Beta A86809H

From human brain tissue, contains both beta-beta and alpha-beta isoforms, > 95% pure From human brain tissue, contains only beta-beta homodimer, > 95% pure (SDS-PAGE)

A86289H

Produced in cell culture, > 50% pure (SDS-PAGE)

From native human liver metastases, > 95% pure (SDS-PAGE)

Thyroglobulin H6T08-747

Cyfra 21-1 A32340H

From human thyroid tissue, > 98% pure (SDS-PSGE) From human thyroid tissue, > 90% pure (SDS-PAGE)

Produced in cell culture, low cross reactivity

A86852H

Human Hemoglobin (Fecal Occult Blood) A38192H From human erythrocytes, > 96% pure (SDS-PAGE)

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Product list

Alpha 1 Acid Glycoprotein (AGP)

Abbreviations

AGP is one of the major acute phase proteins (a class of proteins whose plasma concentrations increase or decrease in response to inflammation). Alterations in the protein levels of AGP have been well documented for numerous physiological and pathophysiological conditions including lung and breast cancer. Antigens A50106H • Native antigen from human plasma • > 95% pure (SDS-PAGE), lyophilized

6-His – Polyhistidine-tag Aff.Pur. – Affinity Purified, analyte-specific column Ag – Antigen Alk.Phos. – Alkaline Phosphatase conjugated product CLIA – Chemiluminescence Immunoassay CVD – Cardiovascular Disease DB – Dot Blot DFA – Direct Immunofluorescence Assay FC – Flow Cytometry FITC – Fluorescein conjugated product GST – Glutathione S-transferase HRP – Horseradish peroxidase conjugated product IB – Immunoblot

Alpha 1 Antichymotrypsin (ACT)

ACT in serum predominantly exists as a complex with Prostate Specific Antigen (PSA). The measurement of free PSA and the PSA-ACT complex may improve the utility of the serum PSA assay by providing a differential diagnosis of prostate cancer versus non-malignant prostate diseases, such as benign prostatic hyperplasia. Antigens A50104H • Native antigen from human plasma • 95% pure (SDS-PAGE), lyophilized

ICC – Immunocytochemistry IEP – Immunoelectrophoresis IFA – Immunofluorescence Assay

IgG – Immunoglobin G IgM – Immunoglobin M IHC – Immunohistochemistry IP – Immunoprecipitation LF – Lateral Flow Lysate – Cells which have been lysed MAb – Monoclonal antibody Monospecific – Single band when tested by immunoelectrophoresis Neat – Whole, unpurified, undiluted antisera Neph – Product has been quality controlled by Nephelometry PAb – Polyclonal antibody Purified/IgG – Refer to the Certificate of Analysis regarding the extent of purification and the purification process used. RIA – Radioimmunoassay RID – Radial Immunodiffusion SDS-PAGE – Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis TIA – Product has been quality controlled by Turbidimetry WB – Western blot

Alpha 1 Antitrypsin (A1AT)

A1AT is a secretory glycoprotein mainly produced in the liver and monocytes. It is the most abundant serine protease inhibitor in human plasma. Several cancers are associated with A1AT deficiency including primary liver carcinoma, lung cancer, bladder cancer and malignant hepatoma. Monoclonals • Does not cross-react with alpha 1 antichymotrypsin

H45200M Antigens A50110H

• Native antigen from human plasma • > 95% pure (SDS-PAGE), lyophilized

Alpha 2 HS Glycoprotein (AHSG)

AHSG is a glycoprotein present in the serum which is synthesized by hepatocytes. AHSG and anti-AHSG autoantibody may be useful serum biomarkers for breast cancer screening and diagnosis. Antigens A50107H • Native antigen from human plasma • > 90% pure (SDS-PAGE), lyophilized

7 | Cancer & Tumor Markers for Assay Development Cancer & Tumor Markers - Reagents for Assay Development 7

Polyclonals CATALOG

Alpha 2 Macroglobulin (A2M)

SOURCE FORMAT APPLICATION

A2M functions as a universal protease inhibitor in serum and is capable of binding various cytokines and growth factors. Malignant tumors are able to synthesize and release proteins into the circulation, including A2M that protects the tumor against immune system attacks. A common variant of A2M has also been suggested to lead to an increased risk of Alzheimer’s disease. Polyclonals CATALOG SOURCE FORMAT APPLICATION L04330G Goat Monospecific IEP Antigens A50114H • Native antigen from human plasma • > 95% pure (SDS-PAGE), lyophilized

K92204R Rabbit

Purified

ELISA

Antigens A01406H

• Native antigen from human cord serum • Suitable for use in ELISA and WB • > 99% pure (SDS-PAGE) • Native antigen from human cord serum • Suitable for use in ELISA and WB • > 99% pure (SDS-PAGE), lyophilized • Native antigen from human hepatocellular carcinoma cell line • Contains approximately 70% of the AFP-L3 isoform • 95% pure (SDS-PAGE) • Suitable for use in ELISA and WB

A01407H

A32260H

Alpha Fetoprotein (AFP)

Amylase Amylase is produced by the exocrine pancreas and the salivary glands to aid in the digestion of starch. Amylase enzyme levels may be increased in some pancreas, salivary, prostate, lung and ovarian tumors. In general, the blood amylase test is used to help diagnose and monitor acute pancreatitis. Polyclonals CATALOG SOURCE FORMAT APPLICATION K50894R Rabbit Purified IEP,WB Antigens A38120H • Native alpha amylase from human pancreas • Specific activity of 450 Units/mg protein (lot dependent) • Purified and lyophilized

AFP is a tumor marker used to help detect and diagnose cancers of the liver, testicles, and ovaries. AFP can be fractionated by affinity electrophoresis into 3 glycoforms: L1, L2, and L3. AFP-L3 is specific to malignant tumors. An AFP-L3 test is used to help evaluate the risk of developing hepatocellular carcinoma, especially in those with chronic liver disease, and also to evaluate response of hepatocellular carcinoma to treatment. Monoclonals • Does not cross-react with human serum albumin • Suitable for ELISA • MAbs produced in vivo (unless otherwise noted)

M01254M M01255M M86304B M86641M M86501M

* Also works in LF assays

* Biotin conjugated

* Reacts with AFP Receptor, suited to blocking AFP/ AFP-binding

A38211H

• Native alpha amylase from human saliva • Specific activity of 620 Units/mg protein (lot dependent) • > 90% pure (SDS-PAGE), lyophilized • Native alpha amylase from pig pancreas • Specific activity of 640 Units/mg protein (lot dependent) • Purified and lyophilized

Antibody Pairs • Suitable for ELISA • MAbs produced in vivo (unless otherwise noted) CAPTURE DETECTION H45610M H45301M

A01389P

* Does not react with human albumin, ferritin, hCG or PSA

MAM01-210 MAM01-301 MAM01-301 K92270G M86304M M86641M

* K92270G is a polyclonal (goat)

* Does not react with human albumin

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Product list continued

Beta 2 Microglobulin (B2M)

Apolipoprotein CI (Apo CI)

B2M is a protein involved with MHC class I molecules which is found on the surface of almost all nucleated cells. Elevated levels of B2M are noted in lymphoproliferative disorders, neoplasms (malignant and benign), inflammatory disease, and autoimmune diseases such as systemic lupus erythematosus and Sjögren’s disease. For cancer, it is not diagnostic for a specific type, but it has been associated with the amount of cancer present (tumor burden) and can be used as a prognostic tumor marker for some blood cell cancers. Monoclonals • Recognizes the HLA-B2M complex, free or associated with the membrane • Suitable for use in FC, IHC and IFA • Lyophilized H42114M • Reacts with soluble forms of B2M and B2M associated with cell-surface MHC Class I molecules and other membrane antigens • Suitable for use in ELISA, WB, FC, IP, and RIA MCP17-301 Polyclonals CATALOG SOURCE FORMAT APPLICATION H01377G Goat Purified IEP K01372G Goat Aff.Pur. N/A K31640S Sheep Aff.Pur. N/A Antigens A01447H • Native antigen from human urine

Apo CI is the smallest member of the apolipoprotein family and is mainly distributed on the surface of very low density lipoprotein (VLDL) chylomicrons and high density lipoprotein. Apo CI is a potential serum marker for colorectal cancer, prostate cancer, breast cancer, lung cancer, thyroid carcinoma, malignant pleural mesothelioma, gastric cancer, pancreatic cancer and Wilms’ tumor. Polyclonals CATALOG SOURCE FORMAT APPLICATION K74110R Rabbit Aff.Pur. ELISA,IB Antigens A50366H • Native antigen from human plasma VLDL • 95% pure (SDS-PAGE)

Apolipoprotein E (Apo E)

Apo E is a class of apolipoproteins found in the chylomicron and intermediate-density lipoprotein. It has been linked to cardiovascular disease, Alzheimer’s disease, dementia, atherosclerosis, multiple sclerosis, peripheral artery disease, diabetes, stroke, and most recently, cancer, including breast and ovarian cancer. Monoclonals • Reacts to the E2, E3 and E4 isoforms of apolipoprotein E • Produced in vivo • Suitable for ELISA, IHC, IP and WB H06579M

• Reacts with VLDL of human plasma • Suitable for use in ELISA and IHC • Produced in vivo , lyophilized H61529M Polyclonals CATALOG

• Suitable for use in ELISA • 98% Purity (SDS-PAGE)

A01410H

• Native antigen from human urine • > 98% Purity (SDS-PAGE), lyophilized • Native antigen from human urine • 98% Purity (SDS-PAGE) • Recombinant (E.coli) • 95% Pure (HPLC), lyophilized

A01412H

SOURCE FORMAT APPLICATION

G5C27-766 Goat K34002G Goat K74190G Goat K62710G Goat K74180B Goat H01378G Goat

Aff.Pur.

N/A

A01468H

HRP

ELISA,WB ELISA,WB

Aff.Pur.

Monospecific IEP,TIA

Biotin

ELISA,WB

Purified

IEP

Antigens A50120H

• Native antigen from human plasma (VLDL) • > 95% pure (SDS-PAGE)

9 | Cancer & Tumor Markers for Assay Development Cancer & Tumor Markers - Reagents for Assay Development 9

Cadherin-E Cadherin-E is a calcium dependent cell adhesion molecule expressed predominately in epithelial tissues. It plays an important role in the growth and development of cells via the mechanisms of tissue architecture and the maintenance of tissue integrity. It is an important determinant of tumor progression, serving as a suppressor of invasion and metastasis (loss of Cadherin-E function promotes tumor progression). Monoclonals • Recognizes Cadherin-E expressed on non-neuronal epithelial cells

Cancer Antigen 125 (CA125) A protein in humans that is encoded by the MUC16 gene and found on the surface of many ovarian cancer cells. Monitoring CA125 blood serum levels is also useful for determining how ovarian cancer is responding to treatment and for predicting a patient’s prognosis after treatment. CA125 can also be found in other cancers and in small amounts in normal tissue. Antibody Pairs

• Detects both Group A and Group B • Suitable for use in ELISA and WB • MAbs produced in in vivo CAPTURE DETECTION M86306M M86924M M86306M M86429M Monoclonals • Suitable for use in ELISA and WB • MAbs produced in vivo M86306B

• Suitable for use in IHC and IP • Produced in vivo , lyophilized P91176M

Calcitonin Calcitonin is polypeptide hormone that is produced by the C-cells of the thyroid gland and it acts to reduce blood calcium (Ca2+), opposing the effects of parathyroid hormone (PTH). Calcitonin assay is used to identify patients with nodular thyroid diseases and to diagnose medullary thyroid cancer. Antibody Pairs

* Specific to Group A, biotin conjugated * Specific to Group B, biotin conjugated

M86429B

Antigens A01693H

• Ovarian Cancer, Calibrator Grade • Low cross-reactivity

• Suitable for use in CLIA, ELISA and RIA • Recognizes Native Human Calcitonin CAPTURE DETECTION E01357M E01356M

A32180H

• Suitable for use as a calibrator for single or multiple analyte controls • Low cross-reactivity ideal for multi-analyte panels • Cell culture derived protein

A97180H

• Cell culture derived protein from ovarian carcinoma cell line • Suitable for use in WB and RIA • Cell culture derived protein from human adenocarcinoma cell line • Suitable for use as a calibrator • Native antigen from human fluids • Suitable for use as a calibrator • Low cross-reactivity • Cell culture derived protein from human adenocarcinoma cell line • Suitable for use as a calibrator • > 50% pure (SDS-PAGE) • Partially pure antigen from human fluids • Low cross-reactivity • Suitable for use in ELISA and Electrochemiluminescence assay as a calibrator or control

Calprotectin L1 Calprotectin L1 is a neutrophil-derived protein that can be quantified in the feces and has become an established marker of whole gut inflammation. Fecal calprotectin levels are associated with lifestyle risk factors for colorectal cancer. Antibody Pairs

A86125H

A43350H

• Suitable for use in ELISA with stool samples • MAbs produced in cell culture, lyophilized CAPTURE DETECTION K01373M K01376M Monoclonals • Suitable for use in ELISA • Produced in cell culture, lyophilized

A86928H

A01690H

K01374M K01375M

Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

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A01436H

• Native antigen from human fluids • High purity (relative Purity Ratio: > 20,000 Units/mL/OD280nm) • Suitable for use in ELISA and WB

Cancer Antigen 27.29 (CA27.29)

CA27.29 is an epitope on the protein core of the MUC1 mucin glycoprotein and is molecularly similar to the epitope for CA15-3. Elevated CA27.29 levels are primarily associated with metastatic breast cancer and is currently used as a tumor marker for treatment monitoring of advanced breast cancer. Monoclonals • Recognizes both cell culture and human fluid derived antigens • The minimal epitope bound is the 8 amino acid sequence SAPDTRPA within the 20 amino acid tandem repeating sequence of the mucin core • Suitable for use in ELISA, WB and IHC • Produced in cell culture M01334M

Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

Cancer Antigen 19-9 (CA19-9) Also called sialylated Lewis (a) antigen, CA19-9 is a tumor marker used primarily in the management of pancreatic cancer. CA19-9 is also elevated in many types of gastrointestinal cancer, such as colorectal cancer, esophageal cancer and hepatocellular carcinoma. Apart from cancer, elevated levels may also occur in pancreatitis, cirrhosis, and diseases of the bile ducts. Monoclonals • Suitable for IHC • Produced in in vivo M01237M Antibody Pairs • Suitable for use in ELISA • MAbs produced in vivo (unless otherwise noted) CAPTURE DETECTION

Cancer Antigen 15-3 (CA15-3 or MUC1)

CA15-3 is a tumor marker which corresponds to an immuno- dominant epitope in the extracellular portion of the membrane bound mucin MUC1. It is used to monitor a patient’s response to breast cancer treatment and disease recurrence. CA15-3 and the associated CA27.29 are different epitopes on the same gene product. Antibody Pairs • Binds to an epitope within the VNTR tandem repeat peptide region of MUC1 • Suitable for use in ELISA and IHC • MAbs produced in in vivo CAPTURE DETECTION SPECIFIC FOR CA15-3 M86240M M01288M * Underglycosylated M86240M M01289M * Underglycosylated M86240M M86240M * Unglycosylated Antigens A32231H • Low cross-reactivity ideal for multi-analyte panels • Suitable for use as a calibrator or control • Suitable for use in CLIA • Cell culture derived protein from human BTA cell line A86153H • Native antigen from human milk

M66106M M66108M M66107M M66106M M66107M M66108M M66108M M66106M M01335M M01335M

* Pair does not cross-react CA72-4, PSA, CA125, CA242, and CEA

* Produced in cell culture, also works in IHC and WB

Antigens A32502H

• Cell culture derived protein from human adenocarcinoma cell line • Suitable for use in CLIA • Native antigen from metastatic liver carcinoma • Suitable for use as a calibrator and an immunogen for antibody development • Cell culture derived protein • Concentrated (~76,000 U/mL), lot dependent

A86199H

A01458H

Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

• Suitable for use as a calibrator or as an immunogen for antibody development • Suitable for use in CLIA and WB • Cell culture derived protein from human BTA cell line

A32000H

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11 | Cancer & Tumor Markers for Assay Development

Cancer & Tu or Markers - Reagents for Assay Development

Cancer Antigen 50 (CA50)

Carcinoembryonic Antigen (CEA) CEA is a type of glycoprotein molecule that is produced by cells of the gastrointestinal tract during embryonic development and CEA is generally present in low levels in the blood. Elevated levels of CEA are detectable in certain types of cancer and to-date CEA is the most widely used tumor marker for assessing prognosis, detecting recurrence and monitoring treatment in people with colorectal cancer. High levels of CEA are also detectable in cancers of the pancreas, stomach, breast, lung, medullary carcinoma of the thyroid, and ovarian cancer. Monoclonals • Suitable for use in enzyme conjugation, radio-labeling or solid phase immobilization • Produced in vivo H45655M • Suitable for use in FC • Specific for epitope group V M01329M Antibody Pairs

CA50 cancer antigen is a glycolipid and elevated levels of CA50 are found in liver cirrhosis and diseases of the pancreas. CA50 is most prevalent in gastrointestinal cancers, but can also be associated with cancer outside the digestive tract. Antigens A01264H • Cell culture derived protein Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

Cancer Antigen CA72-4 (TAG-72)

CA72-4 is a mucinous glycoprotein used as a tumor marker for gastric carcinoma and ovarian cancer (clinical studies demonstrated diagnostic specificity of more than 95%). Elevated CA72-4 levels in serum and plasma have also been reported in other cancers including carcinomas of the pancreas, stomach, gallbladder, colon, cervix and endometrium. There is a good correlation between serologic CA72-4 levels and tumor stage and size. It has been used as an independent marker for the therapeutic monitoring and follow-up care of ovarian cancer patients, in particular in CA125 negative patients. Antibody Pairs

• Suitable for use in ELISA • MAbs produced in vivo CAPTURE DETECTION MAM02-008 MAM02-009 MAM02-009 MAM02-007 MAM02-009 MAM02-008 MAM02-009 MAM02-881 M01250M M01246M

• Suitable for use in ELISA • MAbs produced in vivo CAPTURE DETECTION M01341M M01340M M01342M M01340M

* Also works in IHC

Polyclonals CATALOG SOURCE FORMAT

Cancer Antigen 242 (CA242)

APPLICATION

K10290G Goat

Neat

ELISA

CA242 is related to the sialylated Lewis (a) blood group antigen (Ag-CA19-9) but it is chemically and immunologically distinct. It is used as a tumor marker for the early diagnosis of pancreatic cancer. It has been demonstrated that the CA242 and CA19-9 epitopes are co-expressed on the same mucins, however the detailed structure of the CA242 epitope has not been established. CA242 is suggested to be more specific than CA19-9 in the diagnosis of pancreatic cancer and overall there are differences in the relative expression of CA19-9 and CA242 between benign and malignant diseases and between carcinomas of various organs. Antigens A01267H • Cell culture derived protein • Suitable for use as a calibrator Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

Antigens A01442H

• Native antigen from human fluids • Suitable for use in ELISA • 98% (SDS PAGE)

A32321H

• Purified antigen from cell culture • Suitable for use in CLIA • > 95% pure (SDS-PAGE), immunoaffinity purified

A86808H

• Native antigen from human fluids • Suitable for use in ELISA • Purified antigen from cell culture • > 50% pure (SDS-PAGE) • Purified antigen from human colon adenocarcinoma cell line •  95% pure (SDS-PAGE)

A32030H

A38151H

Please note that cell culture derived antigens offer several advantages over the native fluid versions, including greater availability of the product.

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Monoclonals • Suitable for use in IHC and IP • Produced in cell culture P01242M

Catalase

Catalase is an important enzyme that protects cells from oxidative damage by reactive oxygen species. Catalase is frequently down-regulated in tumors although the underlying mechanism remains unclear. It has been recommended for use as a biomarker for the diagnosis, prognosis, and treatment of breast cancer.

CD3 CD3 consists of a protein complex with four chains and it is required for T-cell activation. CD3 expression can be detected at all stages of T-cell development. Studies have shown that patients with an unresponsive CD3 receptor have a significantly higher incidence of recurrent head and neck squamous cell carcinoma. CD3 is also under investigation as a target for immunosuppressant therapies for type 1 diabetes and other autoimmune diseases. Monoclonals • Produced in vivo MAL66-801

Antigen A50136H

• Native antigen from human erythrocyte • 95% pure (SDS-PAGE) • > 50,000 units/mg protein (lot dependent)

Cathepsin B

Cathepsin B is a member of the peptidase CI family and is produced in muscle tisove during metabolism and . It is known to be involved in cancer progression and invasion. Specifically it has been studied to be a potential prognostic marker for lymph node metastasis in inflammatory breast cancer and as a tumor marker in ovarian cancer and nasopharyngeal carcinoma.

CD4

CD4 positive cells are crucial for the activation and regulation of most aspects of the host’s defense against infections and are central to the pathogenesis of many autoimmune diseases. In addition, evaluation of CD4 and CD8 cells may be used to help classify lymphomas and determine the appropriate therapy. Monoclonals • Suitable for use in FC • Lyophilized P42398M

Antigen A50138H

• Native antigen from human liver • > 95% pure (SDS-PAGE)

Cathepsin D

Cathepsin D is a aspartic protense of the peptidase AI family that clears several substrates such as fibronectin and laminin. It is used as prognostic factor in breast cancer, specifically it can serve as an independent predictor of early recurrence and death in node- negative breast cancer. Mutations in this gene are involved in the pathogenesis of several diseases including Alzheimer disease. Polyclonals CATALOG SOURCE FORMAT APPLICATION K50161R Rabbit Purified ELISA,WB

CD8

CD8 is a transmembrane glycoprotein that serves as a co-receptor for the T-cell receptor. CD8-positive T-cells represent a major arm of the cell-mediated anti-tumor response and a promising target for developing T-cell-based immunotherapies against lung cancer. The chronic presence of lung tumors induces dysfunctions in CD8-positive T-cells and sensitizes them to activation-induced cell death, which may be associated with poor clinical responses. Monoclonals • Produced in vivo MAL08-804

Antigen A50161H

• Native antigen from human liver • 95% pure (SDS-PAGE), lyophilized

CD1d

CD1d encodes a divergent member of the CD1 family of transmembrane glycoproteins, which are structurally related to the major histocompatibility complex (MHC) proteins and form heterodimers with beta-2-microglobulin. Studies have shown that breast cancer cells, through downregulation of CD1d and subsequent evasion of NKT-mediated antitumor immunity, gain increased potential for metastatic tumor progression.

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13 | Cancer & Tumor Markers for Assay Development

ancer Tu or arkers - Reagents for Assay Development

CD9

CD19 CD19 is a co-receptor for CD21 and an important signal transduction molecule which is involved in the regulation of B-lymphocyte development, activation and differentiation. CD19 may provide useful diagnostic information for the study of B-lymphoproliferative disorders. Monoclonals • Can be used to enumerate B-cells in peripheral blood or tissue • Produced in cell culture P01141M • Suitable for use in FC • Produced in vivo , lyophilized P42313M CD24 CD24, a heat stable antigen, is a surface marker expressed in many tumor types. It has been identified as a marker of cancer stem cells (CSCs) and several studies suggest that CD24-positive tumors are related to a poor prognosis and for several cancer types. Monoclonals • Recognizes B-cells from pre-B to mature-B stage

CD9 is a cell surface glycoprotein that is known to complex with integrins and other transmembrane 4 superfamily proteins. The encoded protein functions in many cellular processes and the expression of this gene plays a critical role in the suppression of cancer cell motility and metastasis. Studies have also reported that reduced expression of CD9 is related to aggressive behavior of cancer cells. Monoclonals • Suitable for use in FC • Produced in vivo MAL09-061 * Recognizes an epitope on 2nd extracellular domain (EC2) of CD9 antigen, also works in WB P42117M * Also works in IHC • Suitable for use in WB, IP and IHC • Produced in cell culture P54162M

CD13 (Aminopeptidase N)

CD13 is a Zn 2+ dependent membrane-bound ectopeptidase that preferentially degrades proteins and peptides with a N-terminal neutral amino acid. It has been associated with the growth of different human cancers and is suggested to be a suitable target for anti-cancerous therapy. Monoclonals • Suitable for use in FC and IHC • Produced in cell culture, biotin conjugated P01150B

• Suitable for use in FC and IHC • Produced in vivo , lyophilized P42118M

CD28 CD28 is one of the proteins expressed on T-cells that provides co-stimulatory signals required for T-cell activation and survival. It is also the receptor for CD80 and CD86 proteins. Studies have shown that it is a marker associated with tumoral expansion in multiple myeloma. Monoclonals • Induces T-cell proliferation in co-stimulation with CD2 monoclonal antibodies • Suitable for use in FC • Produced in vivo P42235M

CD15

CD15 is a complex cluster of cell surface glycoproteins and glycolipids having a common terminal pentasaccaharide known as the Lewisx (Lex) antigen. In haematopathology, CD15 is important for the diagnosis of classical Hodgkin’s disease and the characterization of acute leukemia. CD15 may be used for histopathological grading of gliomas and differentiating between malignant gliomas and non-neoplastic glial cells. Hepatocellular, gastric, and colonic carcinoma and thyroid medullary carcinoma also appear to have worse prognosis if positive for CD15. Monoclonals • Suitable for use in FC, IHC and IFA • Produced in cell culture P01158B

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Monoclonals • Suitable for use in FC and IFA • Produced in vivo , lyophilized P42374M

CD29 (Integrin beta-1)

CD29 is an integrin unit associated with very late antigen receptors. It serves as a marker for cancer stem cells (CSCs) and cancer metastisis. CSCs which are enriched for a CD24, CD29 and CD49 display a much higher migration ability. Monoclonals

CD42

CD42 is a cell-surface glycoprotein involved in cell–cell interactions, cell adhesion and migration. It participates in a wide variety of cellular functions including lymphocyte activation, recirculation and homing, hematopoiesis, and tumor metastasis. Monoclonals • Specific for CD42a within the intact CD42a-d complex

• Suitable for use in FC and IFA • Produced in vivo , lyophilized P42598M

CD30

CD30 is a cell membrane protein of the tumor necrosis factor receptor family and a tumor marker. CD30 is associated with anaplastic large cell lymphoma. It is expressed in embryonal carcinoma and on classical Hodgkin Lymphoma Reed-Sternberg cells. In 2011, the FDA approved an agonistic anti-CD30 drug conjugate, Brentuximab vedotin, for the treatment for CD30-positive lymphomas Monoclonals • Suitable for use in FC, IHC and IFA • Produced in vivo , lyophilized P42705M

• Suitable for use in FC, IFA and IP • Produced in vivo , FITC labelled N42538F • Specific for CD42b • Suitable for use in FC • Produced in vivo , lyophilized N42409M • Specific for CD42b • Suitable for use in FC and IFA • Produced in vivo , FITC labelled P42648F

CD37

CD49d

CD37 antigen is a transmembrane protein of the tetraspanin superfamily that is highly expressed on B-cells during the pre-B to peripheral mature B-cells. In normal tissues, CD37 expression is restricted to lymphoid tissues. However, CD37 is highly expressed on malignant B-cells in non-Hodgkin lymphoma and chronic lymphocytic leukemia which suggests that CD37 could be a promising therapeutic target for B-cell malignancies. Monoclonals • Suitable for use in ELISA, IHC and IP • Produced in vivo K8A069M

CD49d is an integrin alpha subunit composed of a β 4 (CD49d) and a β 1 (CD29) chain and serves as a receptor for fibronectin and VCAM-1. It is normally expressed on monocytes, T-cells, and eosinophils and mainly functions as a cell adhesion and signaling molecule. In cancer, it is an independent prognostic marker for disease progression in patients with chronic lymphocytic leukemia. Monoclonals

• Suitable for use in FC and IFA • Produced in vivo , lyophilized P42764M

CD40

CD40 is a TNF receptor superfamily member expressed broadly on antigen-presenting cells and is required for their activation. CD40 expression has been demonstrated in a wide range of tumor cells, including non-Hodgkin’s and Hodgkin’s lymphomas, myeloma and some carcinomas including nasopharynx, bladder, cervix, kidney and ovary. CD40 has shown to be a potential biomarker for atherosclerotic instability.

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15 | Cancer & Tumor Markers for Assay Development

ancer Tu or arkers - Reagents for Assay Development

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