All the necessities, including future plans, are being taken care of by institutions, academia and biotech companies that are increasingly offering the medical community what they need to treat diseases based on their genetic mutations, if any. In recent news, a publicly-traded biotech firm called Foundation Medicine (FMI) has offered the medical community what could bring hope for change in the the treatment of diseases, especially cancers. The change is expected to be great news for cancer patients, the oncologists and the medical community as a whole.
The news announced that the Food and Drug Administration (FDA) approved Foundation Medicine’s sequencing diagnostic test for solid tumors that can detect cancer-causing mutations in 324 genes. The same press release also acknowledges that the United States Centers for Medicare & Medicaid Services announced a preliminary national coverage of the Foundation Medicine’s in vitro diagnostic (IVD) test known as FoundationOne CDx™ (F1CDx) — the first and only comprehensive genomic Profiling Test for all solid tumors incorporating multiple companion diagnostics.
Final Medicare approval will be subject to public comment, the company said.
The Foundation Medicine’s F1CDx test is the second IVD to be approved and covered under the Parallel Review Program, the FDA said on Thursday. The Parallel Review Program facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
The F1CDx test is the first FDA-approved test of its kind for all solid tumors.
The Foundation Medicine’s F1CDx test provides physicians and care givers “potentially actionable information to help guide treatment decisions.” Additionally, the test is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications, the company said.
Other companion diagnostics previously approved by the FDA match one test to one drug. However, the F1CDx provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer, the FDA said in its announcement. Of course the test is expected to be more expensive than the existing one test to one drug.
The regulatory agency added that based on individual test results, the F1CDx can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.
The press release acknowledged that Scott Gottlieb, the FDA Commissioner hailed the approval news, calling the test a “breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs.”
We also learned that Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the F1CDx helps physicians make more informed healthcare decisions without the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial. Shuren said,” With one test doctors and their patients can evaluate several appropriate treatment options.”
Foundation Medicine Chief Executive Officer Troy Cox called the FDA and CMS decision historic.
Approval of the test “represents a major advancement in personalized cancer care,” Cox added.
“Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care,” Cox said in a statement.
Prohost Observations
The news brought a remarkable advancement towards the practice of personalized medicine the way the medical community desires of practice. The above news, we believe, might have offered the oncologists what they wished to have, which is treating cancers based on accurate recognition of their pathways.
We love this news. We congratulate Foundation Medicine (FMI) and believe they will play a major role in improving the treatment of diseases.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
News & Comments
December 5, 2017
Practicing More Personalized Medicine
All the necessities, including future plans, are being taken care of by institutions, academia and biotech companies that are increasingly offering the medical community what they need to treat diseases based on their genetic mutations, if any. In recent news, a publicly-traded biotech firm called Foundation Medicine (FMI) has offered the medical community what could bring hope for change in the the treatment of diseases, especially cancers. The change is expected to be great news for cancer patients, the oncologists and the medical community as a whole.
The news announced that the Food and Drug Administration (FDA) approved Foundation Medicine’s sequencing diagnostic test for solid tumors that can detect cancer-causing mutations in 324 genes. The same press release also acknowledges that the United States Centers for Medicare & Medicaid Services announced a preliminary national coverage of the Foundation Medicine’s in vitro diagnostic (IVD) test known as FoundationOne CDx™ (F1CDx) — the first and only comprehensive genomic Profiling Test for all solid tumors incorporating multiple companion diagnostics.
Final Medicare approval will be subject to public comment, the company said.
The Foundation Medicine’s F1CDx test is the second IVD to be approved and covered under the Parallel Review Program, the FDA said on Thursday. The Parallel Review Program facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
The F1CDx test is the first FDA-approved test of its kind for all solid tumors.
The Foundation Medicine’s F1CDx test provides physicians and care givers “potentially actionable information to help guide treatment decisions.” Additionally, the test is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications, the company said.
Other companion diagnostics previously approved by the FDA match one test to one drug. However, the F1CDx provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer, the FDA said in its announcement. Of course the test is expected to be more expensive than the existing one test to one drug.
The regulatory agency added that based on individual test results, the F1CDx can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.
The press release acknowledged that Scott Gottlieb, the FDA Commissioner hailed the approval news, calling the test a “breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs.”
We also learned that Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the F1CDx helps physicians make more informed healthcare decisions without the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial. Shuren said,” With one test doctors and their patients can evaluate several appropriate treatment options.”
Foundation Medicine Chief Executive Officer Troy Cox called the FDA and CMS decision historic.
Approval of the test “represents a major advancement in personalized cancer care,” Cox added.
“Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care,” Cox said in a statement.
Prohost Observations
The news brought a remarkable advancement towards the practice of personalized medicine the way the medical community desires of practice. The above news, we believe, might have offered the oncologists what they wished to have, which is treating cancers based on accurate recognition of their pathways.
We love this news. We congratulate Foundation Medicine (FMI) and believe they will play a major role in improving the treatment of diseases.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
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