The US Food and Drug Administration UU (FDA) has pbaded a cancer diagnostic test, FoundationOne CDx (F1CDx, Foundation Medicine), for use in the detection of more than 300 genetic mutations in any solid tumor. At the same time, the Centers for Medicare and Medicaid Services (CMS) proposed test coverage.
The simultaneous review of the two agencies took place under the Parallel Review Program, which "facilitates early access to innovative medical technologies". The FDA said in a press release.
This is only the second time that an in vitro diagnostic test has been approved and covered in this simplified manner.
The F1CDx also received the designation "Advancement Device," which was recently established under the 21st Century Cure Act, because it potentially consolidates multiple other complementary diagnostic tests into a single test. That designation resulted in an accelerated 6-month review by the FDA.
"F1CDx can help cancer patients and their healthcare professionals make more informed care decisions without the often invasive process of tumor sampling multiple times to determine eligibility for a single treatment or enrollment in a clinical trial, "said Jeffrey Shuren, MD, director of the Center for Devices and Radiological Health of the FDA, in a press release. "With the completion of a trial, patients and health professionals can now evaluate several appropriate disease management options."
According to the FDA, F1CDx can identify which patients with any of the five types of tumors (non-small cell lung cancer, melanoma, bad cancer, colorectal cancer or ovarian cancer) can benefit from 15 different mutations approved by the FDA. directed treatment options.
Therefore, this test based on next-generation sequencing, which detects potentially 324 genetic mutations and 2 genomic signatures, goes beyond the previous model of "a test for a drug," the agency said.
The effectiveness of the test was established through "a less onerous means" by comparing the F1CDx with the complementary diagnostic tests previously approved by the FDA that are also used to link patients to the treatments. The test accurately detected the types of selected mutations (substitutions and insertions and short deletions) "representative of the entire 324 genetic panel … approximately 94.6 percent of the time," the FDA said.
Application of questioned tumor profile
F1CDx is not the first in vitro diagnostic test based on next generation sequencing approved by the FDA for clinical use in oncology.
Just weeks ago, on November 15, the FDA authorized the use of the Memorial Sloan Kettering (MSK) Cancer Center IMPACT (Integrated mutation profile of cancer targets) tumor profile test, that can identify the presence of mutations in 468 unique genes.
Both are in vitro diagnostic tests that use next-generation sequencing, and both also identify other molecular changes in the genomic composition of a tumor. Both tests have also been touted as useful for enrolling patients in targeted clinical trials of cancer therapies.
As reported previously in Medscape Medical News, a recent study of the online MSK-IMPACT test was published on September 5 in JAMA .
In a case series of 1040 patients with 18 different types of advanced cancer in MSK, 101 of 182 (55.5%) patients with clinically operable mutations would not have been detected by guidelines based on traditional genetic tests, which They translated to 9.7% of the entire cohort of 1040 patients, the MSK researchers reported.
However, in an accompanying editorial, medical oncologist Eliezer M. Van Allen, MD, of the Dana-Farber Cancer Institute in Boston, Mbadachusetts, questioned the clinical utility of these mbadive genetic panels.
"From a practical implementation perspective, significant investments in appropriate infrastructure, pre-test advice To study these tests in multiple contexts, including community settings, he wrote.
He gave an example of the study: They identified approximately two variants of uncertain significance in each of them. "These ambiguous findings may result in higher rates of emotional stress, unnecessary testing, and overtreatment in a population of advanced cancer already taxed," he said.
Precision oncology will need a good amount of studies to determine the therapeutic usefulness of this approach, "said Dr. Van Ellen Medscape Medical News at that time.
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