Time： 2018-11-15 10:24:17
On December 1, the US FDA, Medicare and Medicaid Services Center (CMS) also approved the first breakthrough multi-cancer multi-gene concomitant diagnostic test platform FoundationOne CDx (F1CDx), developed by the tumor genetic testing company Foundation Medicine. , covering 324 genes and two genomic markers (MSI and TMB).
Scientifically, this is the first breakthrough diagnosis of multi-gene and multi-cancer, and it has become a milestone in the field of oncology precision diagnosis based on gene detection in vitro diagnosis. Commercially, after the parallel review and overlapping review of the FDA and CMS, approval and coverage will be approved, or the medical insurance will be promoted to cover this innovative medical technology. Simply put: it is expected to enter the US medical insurance
Jobs, Bill Gates, and Peggy
Foundation Medicine's cancer genome-wide sequencing technology is known for Steve Jobs, the first celebrity to try to use the company's technology. Although he did not recover his life, Jobs was convinced of the value of the test. In an interview with the MIT Science and Technology Review, he said: "I am either the first person to beat cancer in this way, or the last person to die of cancer."
After Steve Jobs's death, doctors who worked at the Massachusetts Institute of Technology and the Harvard-Baud Institute left there and formed Foundation Medicine. Founded in April 2010, Foundation Medicine is based in Cambridge, Massachusetts, and has the most luxurious team of entrepreneurial experts and star investors in history.
From 2011 to 2013, Google’s founder, Page, and Microsoft’s founder, Bill Gates, invested more than $100 million in Foundation Medicine and still have a stake in companies of varying amounts. In addition, Foundation Medicine has a number of prominent investors, including Russian billionaire Yuri Milner and American diagnostics legend Evan Jones. Kaipeng Huaying and Sanshi Venture Capital are both early investors in Foundation Medicine.
Foundation Medicine conducted an IPO on September 25, 2013, and Foundation Medicine received a total of $251 million in investments in the previous two years.
Eric Lander, director of the Broad Institute in Cambridge, is a leading member of the Human Genome Project and one of the founders of Foundation Medicine. The most advanced person in the field of genetic research".
Caption: Steven Kafka, Foundation Medicine, current COO
Foundation Medicine provides the public with a DNA screening service called "FoundationOne", which is the same method that Jobs used. The team continuously analyzes biopsy samples of tumors, and finds the 300 genes most closely linked to cancer, and these genes correspond to specific bodies. Variety.
They then follow a rigorous process analysis report that provides relevant treatment information, including targeted therapies, immunotherapy, and related clinical trials. At present, FMI has accumulated a large sample database, which can be more perfected by comparison and optimization.
The most ideal state is that the doctor can observe and use the genetic testing method to diagnose the patient at any time, and constantly change the therapy in order to achieve the purpose of controlling the disease.
With the cost of developing gene sequencing technology all the way down, the price of this Jobs costing $100,000 in genetic testing services has dropped to $6,000.
Real medical black technology
There is no doubt that it is now in a great era of tremendous changes in medical technology. Large-scale biological sample databases (such as human genome sequences) and other powerful medical technologies (proteomics, metabolomics, genomics, cytology, and mobile medical wearables), computing tools, big data development, precision medical The times are coming to us exponentially at an exponential rate.
Why is F1CDx a milestone product? And what does it have to do with the genetic testing of the Steve Jobs era?
This is the first FDA-approved comprehensive companion diagnostic test for pan-tumor that can: assess all four types of gene mutations of known 324 genes that drive tumor growth, providing information support for clinical decision making; Individual genetic status, identifying advanced cancer patients who may respond to targeted therapies; reporting genomic signals, including microsatellite instability (MSI) and tumor mutation burden (TMB), while reporting (related to other treatments) Genetic variation of other genes for use by patients for patient management.
The first is an accuracy rate of up to 94.6%. Gene mutations or changes, as well as certain microsatellite instability and tumor mutation burden, are determined by sequencing the tumor patient's DNA. By comparing F1CDx with previous FDA-approved companion diagnostic tests, this time covering the entire 324 companion diagnostic gene detection methods, the accuracy rate reached 94.6%.
The second is to go beyond the "one-on-one" model. The F1CDx platform can detect genetic mutations in any solid tumor, and this information can help doctors diagnose cancer patients according to guidelines. In addition, it can be used as a companion diagnostic to identify potentially FDA-approved drugs to help patients with non-small cell lung cancer, melanoma, breast, colorectal or ovarian cancer receive precise treatment. The F1CDx platform can detect genetic mutations associated with multiple FDA-approved treatment regimens, beyond the previous “one drug for one test” model, and combining diagnostics and treatment to greatly advance tumor genetic testing from laboratory technology Clinical practice.
The third is to avoid repeated intrusive tests such as biopsy. F1CDx can help cancer patients and their health workers to make more precise, non-invasive (invasive procedures that do not require multiple extractions of tumor samples) to determine whether a single treatment or clinical trial can be performed.
The FDA's Center for Devices and Radiology (CDRH) said: "With such a test, patients and healthcare professionals can now evaluate in vitro diagnostics and personalized treatments for a variety of applicable diseases."
Sandra Horning, Roche's Chief Medical Officer and Head of Global Product Development, said: "Patients can benefit from this comprehensive pan-tumor-associated diagnostic test, helping them choose the right approved therapy based on their tumor molecular footprint. We believe that the gene Profiling will gradually become a routine practice in clinical practice, so we worked closely with Foundation Medicine to develop a comprehensive clinical and analytical validation platform to help meet today's and tomorrow's companion diagnostic needs."
Currently, 17 approved therapies have been included in the FoundationOne CDx report, 12 of which have been approved as first-line treatment options within the respective indications. As Foundation Medicine and its partners receive FDA approval to include more biomarkers in this platform, the targeted therapies covered in the report will gradually increase.
Roche acquired a majority stake in Foundation Medicine in April 2015 and became its controlling shareholder; and since then has actively promoted Foundation Medicine products outside the United States, and FoundationOne is now available in more than 20 countries on three continents.
It is understood that Foundation Medicine has received FDA "breakthrough in vitro diagnostic products" and CMS parallel review approval. In this program, the FDA determined the coverage of medical insurance within six months of receiving the product application. The FDA says that through these two accelerated policy efforts, patients can get breakthrough diagnostic applications faster, helping doctors to personalize cancer treatments.
We believe that the era of precision medicine has arrived and related technologies are ready. However, precision medicine has always had a problem in cutting-edge technology and commercial applications: due to the characteristics of its personalized treatment, its commercialization threshold is high. To some extent, the precise medical care at this stage is still able to bear part of the cost. Terminal illness can save lives through new biological immunotherapy. However, we also believe that the door to precision medical care will be more and more open to ordinary consumers at an exponential rate under the protection of rapid technological development, and become part of Pratt & Whitney Medical.