Comprehensive Tumor Markers Solution

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Tumor markers in general

Worldwide, an estimated 19.3 million new cancer cases and almost 10.0 million cancer deaths occurred in 2020, account for nearly one in six
deaths. The most common cancers are breast, lung, colon and rectum and prostate cancers.

Ranking of cancer
Premature mortality（�-��）
1st（57）
2nd（55）
3rd-4th（23）
5th-9th（48）

No date Not applicable

When identified early, cancer is more likely to respond to treatment and can result in a
greater probability of survival with less morbidity, as well as less expensive treatment.
Nowadays, the determination of tumor markers is an integral part of tumor diagnostic procedures, together with e.g. x-ray studies,endoscopic
examinations, bone marrow aspirations, ultrasound imaging, magnetic resonance imaging (MRI), etc.

What are tumor markers?

They are substances produced by cancer cells or organism which in reaction to the tumor growth.

They are localized on the cell membrane of tumor cell, or in its cytoplasm (enzymes of metabolic pathways, fragments of cytoplasmic
structures), and may be determined either directly in the cells, or in blood and other body fluids.

Tumor Marker

Environment

Normal cell Dysdifferentiated Carccinoma in situ Infiltrating Carcinoma Metastatie Careinoma

Gene Mutation Tumor Marker Testing Imaging and Pathological Examination

What are the values of tumor markers?

In ideal cases, tumor markers may detect tumor mass of 1 mg (approx. 106 cells), whilst clinical diagnosis by means of imaging techniques is
possible in tumor consisting of not less than approximately 109 tumor cells. Therefore, tumor markers are best used in the early detection of
recurrence, also, they can contribute to distinguishing between malignant and benign tumors, to assessing the stage of the disease, to evaluat-
ing the efficacy of treatment.

Tumor Markers

Imaging Techniques
The Reduced
Time
Growth in Tumor Size

Tumor Weight 1pg 1mg 1g 10-100g 1kg

Number of Tumor Cells 103 106 109 1010-11 1012

Tumor markers are important for early detection of tumors.

Possible use of tumor markers

Screening
Unfortunately, none of tumor markers fulfilled the requirement of specificity and sensitivity for screening. In fact, the so called “PSA screening”,
which has been implemented in many countries, also is not the screening in the real sense of the term. It is performed only in certain population
(men over certain age), and thus it should be rather considered as an early diagnosis at the selected (high risk) group.

Healthy Cells Abnormal Cells Pre-invasive Cancer Invasive Cancer Cancer Spread Death

Screening Early Diagnosis

Service Provided for a Service Provided Only

Target Population for People with Symptoms

Symptom Onset
 Primary diagnostics
Suitability of tumor markers for primary diagnostics is limited, too. The main reasons are again their low sensitivity and specificity.

Differential diagnostics
The use of tumor markers may be profitable in certain cancers, mainly in testicular tumors, chorio-epitelioma, neuroendocrine tumors and lung
tumors.

Follow-up
Long term follow-up appears to be the most important indication for tumor markers. Usually, tumor marker levels may increase several months
before clinical manifestation of the disease (so called lead-time). The dynamics of tumor marker changes gives more useful information than
absolute level itself.

Scheme for tumor marker follow-up intervals may be modified in dependence on cancer and on the markers used. Example of such scheme
is below:

First determination before treatment (surgery)

Post-operative determination 14 days after surgery

Three determinations with one-month interval

Determination each 3-4 months up to three years after surgery

After that, twice a year.

Note: Frequency of testing has to be increased when signs of progression appear.

 Monitoring of therapy
Serial measurements are usually more meaningful than a single measurement during treatment process or after treatment to check whether
the treatment makes sense or return of cancer (in the same testing system).

Right timing of blood sample collection is necessary to reflect the real effect of therapy, not only so called “lysis phenomenon”.

As it is necessary to respect biological half-life of tumor marker, the sample is usually collected three or four weeks after therapy application.

800
Diagnosis

600
CA125 U/ml

400 Surgery Recurrence

Chemotherapy

200 Recurrence
Remission
Remission

0
Apr.94 Nov.94 Apr.95 Feb.96 Jun.96 Dec.96 Sep.97

Recommendations for combined detection of tumor markers

It is clear that it is not possible to base the diagnoses on tumor markers only, as there is not yet a tumor marker with sufficient sensitivity and
specificity. The combined detection of tumor markers can complement the deficiency, improve the clinical application value, and be widely
used in practice.
 Tumor Marker
Localization an type of cancer
With biggest diagnostic value Supplementary marker

Breast CA 15-3, CEA CYFRA 21-1

NSCLC CYFRA 21-1, SCCA CA 125

SCLC NSE, proGRP CYFRA 21-1

Colorectal CEA CA 19-9

Prostate PSA, fPSA PAP

Gastric PGI, PGII, G-17, CA 72-4 CEA

Bile duct and liver CA 19-9, CEA, AFP CA 15-3, SCCA, CYFRA 21-1

Ovarian CA 125, HE4, CA 72-4 CA 19-9, CYFRA 21-1, AFP, CEA

Uterus SCCA, CYFRA 21-1 /

Esophageal SCCA, CA 72-4 TPA

Pancreas CA 19-9 CA 242, CEA

Assay Information

Package Specification Sample Type/ Preparation Measurement

Product
Cat No. Principles Min. Sample Before range Shelf-life Traceability
Name
Reagent Calibrator Control Volume (μL) Usage

01.09.49. 2 level* 2 level* 2-8℃

50 T/Kit Unopened: International
AFP Assay 03.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 1.0-1210
12 months reference
(CLIA) method plasma/5 to Use ng/mL
01.09.49. 2 level* 2 level* Opened: AFP
100 T/Kit
03.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: NIBSC
CEA Assay 07.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.5-1000.0
12 months 73/601
(CLIA) method plasma/10 to Use ng/mL
01.09.49. 2 level* 2 level* Opened:
100 T/Kit
07.01.02 1.0 ml/vial 2ml/vial 28 days

01.09.49. 2 level* 2 level* 2-8℃

50 T/Kit Unopened: Manufacturer's
CA 50 Assay 12.01.02 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 1-500
12 months Working
(CLIA) method plasma/5 to Use U/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
12.01.01 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
CA 125 00.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 1-5000
12 months Working
Assay(CLIA) method plasma/10 to Use U/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
00.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
CA 15-3 04.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 1.0～300
12 months Working
Assay(CLIA) method plasma/15 to Use U/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
04.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
CA 19-9 02.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 1.0-1000
12 months Working
Assay(CLIA) method plasma/15 to Use U/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
02.01.02 1.0 ml/vial 2ml/vial 28 days
 Package Specification Sample Type/ Preparation Measurement
Product
Cat No. Principles Min. Sample Before range Shelf-life Traceability
Name
Reagent Calibrator Control Volume (μL) Usage

01.09.49. 2 level* 2 level* 2-8℃

50 T/Kit Unopened: Manufacturer's
CA 242 13.01.02 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.5-200
12 months Working
Assay(CLIA) method plasma/5 to Use U/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
13.01.01 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
CA 72-4 05.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.2-300.0
12 months Working
Assay(CLIA) method plasma/20 to Use U/mL
01.09.49.0 2 level* 2 level* Opened: Calibrator
100 T/Kit
5.01.02 1.0 ml/vial 2ml/vial 28 days

01.09.49. 2 level* 2 level* 2-8℃

50 T/Kit Unopened: Manufacturer's
NSE Assay 06.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.05-370
12 months Working
(CLIA) method plasma/10 to Use ng/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
06.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
proGRP 08.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 2-5000
12 months Working
Assay(CLIA) method plasma/30 to Use pg/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
08.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
CYFRA 21-1 16.01.02 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.1-500
12 months Working
Assay(CLIA) method plasma/10 to Use ng/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
16.01.01 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
SCCA 14.01.02 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.1-70
12 months Working
Assay(CLIA) method plasma/5 to Use ng/mL
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
14.01.01 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
15.01.02 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 5-1500
HE4 (CLIA) 12 months Working
method plasma/5 to Use pmol/L
01.09.49. 2 level* 2 level* Opened: Calibrator
100 T/Kit
15.01.01 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened:
Total PSA 10.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.01-100 NIFDC
12 months
Assay(CLIA) method plasma/15 to Use ng/ml 150543
01.09.49. 2 level* 2 level* Opened:
100 T/Kit
10.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened:
Free PSA 11.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.05-50 NIFDC
12 months
Assay(CLIA) method plasma/10 to Use ng/ml 150544
01.09.49. 2 level* 2 level* Opened:
100 T/Kit
11.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.49. 2 level* 2 level* 2-8℃
50 T/Kit Unopened:
Ferritin 01.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.5-2000 NIBSC
12 months
Assay(CLIA) method plasma/5 to Use ng/mL 19/118
01.09.49. 2 level* 2 level* Opened:
100 T/Kit
01.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.46. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
Gastrin 17 02.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.2-500
12 months Working
Assay(CLIA) method plasma/30 to Use pmol/L
01.09.46. 2 level* 2 level* Opened: Calibrator
100 T/Kit
02.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.46. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
PG I Assay 00.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.5-200
12 months Working
(CLIA) method plasma/10 to Use ng/mL
01.09.46. 2 level* 2 level* Opened: Calibrator
100 T/Kit
00.01.02 1.0 ml/vial 2ml/vial 28 days
01.09.46. 2 level* 2 level* 2-8℃
50 T/Kit Unopened: Manufacturer's
PG II Assay 01.01.03 1.0 ml/vial 2ml/vial Sandwich Serum, Ready 0.1-100
12 months Working
(CLIA) method plasma/10 to Use ng/mL
01.09.46. 2 level* 2 level* Opened: Calibrator
100 T/Kit
01.01.02 1.0 ml/vial 2ml/vial 28 days
Zybio Inc.
Address: Floor 1 to Floor 5, Building 30, No.6 of Taikang Road,
Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing,
PEOPLE’S REPUBLIC OF CHINA
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Email: [email protected] Website: www.zybio.com

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