January 2017

Innovating to TAKE ON CANCER

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Distinguished service provider Cancer Genetics, Inc. (CGI) has a proven track record of simplifying issues faced by oncologists by offering them critical and clinically actionable information, says Dr. Mandar Kulkarni, CTO of Cancer Genetics, Inc. in an interview with Elets News Network (ENN).

How is cancer diagnostic landscape evolving in India?

Effective early diagnosis is the cornerstone of efficient clinical management of cancer. Majority of oncologists in India depend on their clinical experience and rely heavily on gold standard testing methods, although the neo-oncological precision medicine approach has begun to emerge as an important component of the cancer diagnostic paradigm. The precision oncology approach exploits technological advances in DNA sequencing to identify several ‘cancer driving’ mutations from an individual’s tumor, and is used to improve treatment outcomes by predicting tumour behaviour and the patient’s response to the chosen drug regimens.

Several organic efforts, including cancer screening camps and general health screenings, continue to raise awareness about early and accurate detection of cancer in India. Easy access to information about the impact of the state-of-the-art DNA sequencing methods on making better therapeutic choices is increasing the demand of such testing in the Indian market. There has been an increase in the development of drugs that target cancer promoting genomic changes and warrant testing for the presence of such changes in each cancer patient prior to choosing drug regimens. The affording urban population is demanding clinical cancer management inline with that available in developed countries. All these factors, although highly conducive for rapid adoption of advanced precision oncology testing, are outweighed by the inability of a much larger non-urban Indian population that cannot bear the high cost of these tests offered in a highly price sensitive market. Therefore, adoption of advanced precision oncology tests is currently limited to a small sub-section of the society from tier one cities. At the same time, several service providers that offer such tests are focusing effort on modifying the tests to lower costs yet maintain the utility and quality of the test. Lastly, in the interest of high quality testing that can save lives of cancer patients, a regulatory framework that qualifies clinical service providers is required.

Dr. Mandar Kulkarni, CTO of Cancer Genetics

What are the key solutions being offered by CGI?

CGI has an established track record of developing many solutions that detect several mutations and other genomic aberrations from tumour tissues or liquid biopsies (circulating tumor cells, circulating tumor DNA or cell-free DNA). The clinical relevance and the collective impact of all changes detected in the tumour allow medical directors at CGI to effectively interpret the data and provide a report to the medical oncologist so that s/ he may choose the most effective approach for clinical management of the patient. Cancer Genetics India offers sequencing of a panel of 50 genes that are generally mutated in solid tumors such as breast, colon, lung, gastrointestinal, and ovarian. DNA extracted from clinical samples is tested for mutations in genes that are targeted for therapy (e.g. Her2 targeted by trastuzumab or lapatinib, EGFR targetted by cetuximab or erlotinib, KIT, RET, PDGF-Rs, VEGF-Rs targeted by sunitinib). Mutations in other genes included in the panel maybe indicative of the invasiveness of the tumour. Such information is useful for the physician to set the patient’s expectations about therapeutic management and outcome. At CG-India we plan on continuing to build on this offering and bring state-of-theart NGS-based cancer diagnostic capabilities from the western world to the Indian community. Conducting studies that focus on re-validating a few NGS-based diagnostic panels for the Indian population and developing novel panels relevant to the Indian market are on our priority list.

Who are your key collaborators in India? Please tell us about your recent projects implemented here?

We collaborate with several super- specialty cancer hospitals as well as academic cancer centers to develop and validate precision oncology solutions and to enable discovery projects in the translational oncology area. One of our current projects focuses on validating a fluorescence in situ hybridisation based FHACT test to detect cervical cancer from abnormal pap smears. Another project is to identify a genomic signature/ biomarker for early detection of oral cancer. We are validating several multigene panels for improved patient stratification and therapeutic guidance in lung cancer and leukemia patients. Lastly, we are working towards assessing the utility of a multigene test that will predict response to immune-therapy for lung cancer.

What are the key challenges faced by healthcare providers in diagnosis of cancer?

One of the major challenges faced by oncologists is that they have a wide array of therapeutic agents to choose from. Prior to the advent of targetted therapies the choice was guided primarily by clinical experience and tumor type. Today we have several targeted therapies to choose from. Each drug is specifically designed to attack tumor cells that harbour the targetted genomic change. Without the knowledge of the genomic changes driving tumor growth choosing the most efficacious drug is challenging. More recently, immunotherapy has added a new dimension to clinical management of cancer. The efficacy of drugs that block immuno-suppression and enable the patient’s immune system to attack the tumour can be predicted by genomic testing as well. Large data volumes and complex data interpretation schemes present another challenge for clinicians. Distinguished service providers like CGI have a strong track record of simplifying these problems and presenting only the critical and clinically actionable information to clinicians.

Which technological innovations according to you look promising in containing the rising incidences of cancer?

Next generation sequencing technology has already revolurevolutionised our approach and has enabled us to take big strides in the area of precision oncology. Continued decrease in the cost of sequencing, the increased ease of operating the sequencing machines, and decreasingly complex workflows for performing genomic tests is expected to drive adoption of these tests. Automation in the “data-to-reporting” pipelines will also greatly affect the timeline and accuracy of obtaining clinically actionable information for each patient. Field deployable miniaturized sequencers, and innovative approaches to enrichment of genomic targets for testing are expected to contribute significantly to improving the laboratory workflows.

Please apprise us about your future expansion plans.

We are currently focusing on building a comprehensive portfolio of personalized oncology testing services. We are also supporting efforts for the discovery of new genomic biomarkers for early detection of cancer. We intend to transform our bioinformatics facility into a center-of-excellence to support discovery pipelines as well as automate the clinical reporting workflows.

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