FDA Approves Genetic Test for Cancer

A new test that can match genetic mutations in five distinct cancers to many approved drugs and disease management options has been approved by the US Food and Drug Administration.

The test can be utilized with other diagnostic data to match patients’ tumors to drugs already approved by the FDA in five different cancer types, including non- small cell lung carcinoma, melanoma, breast cancer, colorectal cancer and ovarian cancer.

The US Food and Drug Administration (FDA) has approved a genetic test that can identify mutations in solid tumors in 324 genes. The test, known as F1CDx, utilizes next-generation sequencing to sequence DNA from a patient’s tumor test and furthermore detects two characteristics “genomic marks”.

The data from the test can be utilized by doctors to control treatment and administration. In five cancer types, non-small cell lung carcinoma, melanoma, breast cancer, colorectal cancer and ovarian cancer. The test can be utilized alongside other diagnostic information to match patients’ tumors to drugs already approved by the FDA.

Remarkably, the test can match genetic mutations to different treatments, though most previous tests approved by the FDA have just covered mutations for a single drug.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said, “The F1CDx can help cancer patients and their healthcare professionals make on more informed care decisions without the frequently invasive procedure of extracting tumor samples multiple times to determine eligibility for a single treatment or enrolment in a clinical trial. With the run running of one test, patients and healthcare professionals would now be able to evaluate a few appropriate disease management options.”

The FDA evaluated the test by comparing it and approved companion diagnostic tests that are at present used to determine patients’ eligibility for certain treatments.

The outcomes demonstrated that the test could precisely distinguish detect types of mutation (substitutions and short insertions and deletions) around 94.6% of the time. The approval was part of an approval of an expedited process for ” breakthrough diagnostics” that offer the more effective diagnosis for life-threatening or debilitating conditions than current standards-of-care.

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