24 Apr New Platform Aims To Improve Cancer Markers Braf p.V600E/K Mutations

MedicalResearch.com Interview with:

Dr. Moorthy

Thurai Moorthy Ph.D.
President, MultiGEN Diagnostics
Greensboro, NC 27405

MedicalResearch.com: What is the background for this study?

Response: As more cancer related genetic markers are reported, there is a need for appropriate molecular tests to meet clinical expectations. These expectations include detection at very low amount in a heterogeneous cell population, such as Formalin Fixed Paraffin embedded (FFPE) tumor biopsies.

Braf p.V600E/K mutations are cancer-specific markers found in a variety of cancers. There are several drugs in use, and more drugs are being developed, which are prescribed only to those patients whose tumor carries either of these (Braf p.V600E/K) mutations.

Hence, detection of Braf p. V600E/K is critical in the treatment of cancer patients. In this regard, we developed a new platform technology, Allele Specific Multiplex Sequencing (ASMS, for the detection of cancer markers from biopsy samples. As a demonstration project, we tested the new platform technology for the detection of Braf p.V600E/K using tumor samples (FFPE) previously tested by two presently used methods.

MedicalResearch.com: What should readers take away from your report?
Response: There are three take away messages
a. Cancer treatment.

• The use of ASMS Braf p.V600E/K could include patients presently left out of the intended chemotherapy. However, this may need additional clinical trials correlating the level of detection to treatment outcome.
• A false negative could lead to switching to an alternative treatment, such as immunotherapy. This approach could leave the Braf mutation-initiated proliferation intact, while immunotherapy is in place. Hence, it is counterproductive. The patient could be left with the possible side effects from treatment without therapeutic benefits.

b. Clinical trials. Presently there are more kinase inhibitors being developed and taken through clinical trials, which require an effective test to select patients with Braf p.V600E/K mutations for treatment with the intended drugs. At the same time, a false negative in the control group may lead to erroneous results. Hence, the use of ASMS Braf p.V600E/K assay could help to enroll appropriate patients for the trials and aid in conclusive interpretation of the findings.

c. Prevalence of cancer markers. Presently the prevalence of Braf p.V600E/K mutations vary from 50% in melanoma, 40% in thyroid cancer, 5% in colorectal, etc. Use of ASMS Braf p.V600E/K test could re-evaluate these percentages in various cancers. Such re-evaluation could help in the study of the inter-play among these markers for a better understanding of cancer progression.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Laboratory investigation is an important component for patient care leading to appropriate treatment. All laboratory investigation includes the detection of specific cancer marker(s), and the validity of the method used to detect them.

We have two key recommendations:
• The cancer markers have to be well characterized, possibly with acceptable molecular mechanism rather than on mere speculation based on clinical correlation.
• Although various methods could be used for research purposes, when it is applied to clinical setting the test must meet the clinical expectations regarding limits of detection, sensitivity, etc.

MedicalResearch.com: Is there anything else you would like to add?

Response: Over the past two decades, molecular diagnostics has been mainly platform driven. Although each diagnostic platform may meet its expectation in the intended primary market, extending to other market segments could compromise respective expectations. In order to overcome these limitations, MultiGEN draws specific platforms from its portfolio of intellectual properties. Detection of Braf p.V600E/K is one of them.
Using ASMS Braf p.V600E/K we are expanding our study to detect other cancer markers (e.g. Kras, EGFR, etc.) that are associated with solid tumors. Further, we are also developing more sensitive tests to detect cancer markers from blood (circulating cell free tumor markers).

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Can detection of Braf p.V600E mutation be improved? Comparison of allele specific multiplex sequencing to present testsThuraiayah Vinayagamoorthy, David Zhang, Fei Ye, Dilanthi Vinayagamoorthy, Roger Hodkinson
Journal of Solid Tumors
DOI: https://doi.org/10.5430/jst.v7n2p14

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on April 24, 2017 by Marie Benz MD FAAD