The U.S. Food and Drug Administration (FDA) regulates the safety, effectiveness, sales and distribution of cancer profiling tests. On November 15, 2017, FDA authorized Memorial Sloan Kettering Cancer Centerâ€™s (MSK) IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The test is capable of high throughput screening and identification of a higher number of mutations using biomarkers of different cancer types.
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Along with this new test authorization, FDA recognized wider acceptance of cancer profiling tests for better treatment of cancer and streamlined policy framework for the efficient review process and faster availability of NGS-based cancer profiling tests. The new framework allows review of the tests by accredited third-party to reduce the test developerâ€™s burden and streamline ensuing regulatory assessment procedures. This step has paved a way for NGS-based cancer profiling tests manufacturers to elude tedious regulatory process of authorization and faster entry to the market.
Traditionally treated on the basis of body location with a one-size-fits-all approach, cancer treatment is evolved significantly wherein precision medicine has aided in better cancer management. Identification of the target mutation with cancer profiling assists in determining highly specific drug that delivers long-lasting remission and expansion of lifetime.
Personalized medicine approach in cancer treatment involves genetic information of an individual and his or her cancer cell profile. In addition, lifestyle, diet, microbiome and other information of an individual is also covered while determining the personalized treatment approach. As cancer profiling helps in delivering genetic information of cancer cells, ongoing R&D activities in the field of precision oncology present lucrative avenues for cancer profiling manufacturers.
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According to the World Health Organization (WHO), cancer is the second leading cause of death globally and is responsible for nearly 9.6 million deaths in 2018 worldwide. While major strides are being made to prevent cancer development, the medical community still need to address the estimates of new cancer cases projected in coming years. WHO estimates the global burden of cancer to have risen to 18.1 million new cases in 2018.
As the incidences of rare cancer continue to rise, personalized medicine is providing promising results in cancer treatment. Cancer profiling is aiding the personalized treatments by providing the identification of specific gene mutation and use of targeted therapies.
With the growing emphasis on collaborative treatment to address cancer treatment issues effectively, development of common datasets is underway which can be used to interpret cancer profiling results and improve the treatment of cancer patients.
The Blood Profiling Atlas in Cancer (BloodPAC) Consortium launched a dataset for liquid biopsies and announced public release and accessibility of initial dataset in February 2018. Max Cancer Center in India recently published development of a web-based genome profiling interpretation tool â€" DrAV tool. The tool provides a platform for genomic data extraction and analysis of clinical information to aid precision oncology and cancer profiling processes.
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