Kits of reagents for molecular genetic

 

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Kits for noninvasive prenatal testing

Noninvasive fetal gender and Rhesus factor testing is a method of genetic laboratory testing that enables the results using maternal blood in the early stages of pregnancy (since 10th week) with accuracy of 99%. The results are based on fetal DNA detection in a pregnant woman’s blood.

The kits are based on real-time PCR technique. The novel approach improves the sensitivity and allows detecting even single DNA copies in maternal blood. To achieve it, ultra-short probes, unique primers and high processive hot-start polymerases are used.

Diagnostic kits for fetal DNA detection produced by TestGene have Registration Certificate # RZN 2015/2703 issued by the Federal Service on Surveillance in Healthcare.

«Тest-SRY» - kit for noninvasive fetal gender detection since 10th week of pregnancy has a particular importance for families at the sex-linked disease risk.

«Тest-RHD» - kit for noninvasive fetal RHD gene detection since 10th week of pregnancy.

Benefits:

  • timely and reasonable measures to prevent RhD conflict
  • 35% savings of the government budget
  • savings for a pregnant woman
  • Awareness of fetal RhD status allows obsterician-gynecologist to provide a Rhesus-negative pregnant woman with necessary treatment.

Kits for cancer testing

Prostate cancer ranks the 3d or 4th position in the world’s incidence rate of malignant neoplasms, more than 600 thousand cases per year.In the USA, it is the first most frequently diagnosed among cancer diseases – more than 200 thousand patients per year. In Europe it is the first of second most frequently diagnosed in men (more than 200 thousands of patients per year)

«Prosta-test» is designed for noninvasive prostate cancer diagnostics by determinants of PCA3 gene expression level by reverse transcription followed by quantitative polymerase chain reaction (PCR).

Material for PCR – human RNA samples derived from fresh or fixed in the medium in order to stabilize and preserve urine RNA obtained after digital rectal examination (DRE) of the prostate, thus achieving noninvasiveness.

The result of “Prosta-test” expressed quantitatively indicates the risk of prostate cancer presence and may serve as an additional criterion for the first or subsequent biopsy appointment along with the measurement of the PSA level in the blood, ultrasonography (TRUS), MRI, CT and digital rectal examination (DRE).

 

Kits for identification of the mutations associated with targeted therapy response or resistance

TestGene’s kits for mutation in EGFR&KRAS genes detection serve 50% of all such tests which are implemented in Russia. Those kits have successfully passed prequalification in European Molecular Genetics Quality Network (EGFR) and Pathologisches Institute (KRAS). Quality control was carried out on the basis of molecular diagnostic laboratory “Republican Clinical Oncology Center” of the Ministry of Health Care of the Republic of Tatarstan.

It is extremely important to detect mutation status of EGFR and KRAS while selecting a medication to be sure that patients are treated in accordance with the molecular features of the disease. The kits are completely free from disadvantages of other approaches, such as: the need for quantitative calibration of DNA sample, the presence of non-specific signal in the absence of mutation, subjectivity analysis of results, false positive results in cases of excess of the recommended amounts of test material.

The type of TaqMan technology used in the kits (based on destructible oligonucleotide probes with chemical modifications of locked nucleic acids) has a high sensitivity and specificity. Depending on the total amount of DNA in the sample, there is up to 1% of mutant against a background of wild DNA determined with an accuracy of at least 99,9%.

The features of the kits allow detecting reproducibly mutations presented even in low concentration and minimizing the probability of false-negative results. The kits are compatible with all common real-time PCR thermocyclers ABI 7300/7500/StepOne, Bio-Rad iQ5/CFX, Rotor-Gene 3000/6000, DT-prime and etc.

The kits allow implementing detection directly from tumor tissue of biopsied material. Version of kits for circulating tumor DNA detection allows testing of patient’s plasma or serum.

 

 DNA-Plant is the kit of reagents used for plant DNA detection from different sources: plant raw materials, feeding staff, vegetable based food, etc.