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FDA Streamlines Tedious Regulatory Process of Cancer Profiling Test Authorization
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 Center’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.
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 developer’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.
Cancer Profiling Complements Ongoing Precision Oncology R&D Activities
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.
Rising Cancer Burden Necessitates Utilization of Cancer Profiling Tests
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.
Development of Datasets and Interpretation Tools Increases Cancer Profiling Precision
Major R&D investments in the cancer profiling market are being utilized in developing platforms for genomic data and clinical information to enhance the current capabilities of genomic profiling tests for different types of cancers. The current landscape of cancer profiling is facing challenges of clinical translations due to lack of sufficient consensus for treatment development and time-consuming interpretation. 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 – 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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The report also profiles companies that are expected to remain active in the expansion of global cancer profiling market through 2026, which include Agendia, Genomic Health Inc., Oxford Gene Technology Ltd., NeoGenomics Laboratories, RiboMed Biotechnologies Inc., BioTheranostics, Proteome Sciences PLC, Illumina, Inc. (U.S.), GenScript, Caris Life Sciences, and Roche Holdings.
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Cancer Profiling Market: Precise Scenario Covering Trends, Opportunities and Growth Forecast during
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