It looks like the FDA has just approved a DNA-based cancer predisposition test. Here are the most important details that have been just revealed,
FDA approves DNA-based cancer predisposition test
The first-ever DNA test that can predict the possibility of developing specific types of cancer has been granted marketing authorization by the U.S. Food and Drug Administration (FDA). Biotech firm Invitae’s “Common Hereditary Cancers Panel” has been authorized for sale by the FDA on Friday.
The test analyzes DNA extracted from a blood sample and identifies hundreds of genetic variants that are linked to a higher risk of developing cancers such as those that affect the breasts, ovaries, uterus, prostate, colon, rectum, and stomach. The test can identify variants in 47 genes and offers a simpler way to determine the likelihood of developing cancer.
“The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer,” the FDA said in a Sept. 29 press release. The DNA blood test is the “first of its kind to be granted FDA marketing authorization.”
“This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Invitae conducted a blood test to accurately identify cancer risks. To validate the test’s effectiveness, Invitae used over 9,000 clinical samples, resulting in an accuracy rate of over 99 percent, as stated by the FDA.
However, the test comes with some risks.
False positive and false negative test results are possible. Additionally, there is a possibility of misunderstanding the results.
In case of false negative results, people with cancer may believe that they are cancer-free and, as a result, may not receive the necessary care.
On the other hand, false positive results may cause people to assume they have cancer when they do not. This can lead to inappropriate decision-making regarding their lifestyle and healthcare.
The FDA stressed that Invitae’s test is not aimed at identifying all known genes that are associated with a predisposition for cancer.
“Genetics are not the only factor in development of cancer,” it said.
“Some of the most clinically significant genes that the test identifies are: BRCA1 and BRCA2, which are genes with known associations to hereditary breast and ovarian cancer syndrome, Lynch syndrome associated genes (MLH1, MSH2, MSH6, PMS2 and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer, and lobular breast cancer) and STK11 (associated with Peutz-Jeghers Syndrome).”
According to the FDA, Invitae’s “Common Hereditary Cancers Panel” was granted a “de novo” marketing authorization. The “de novo” authorization was granted under the agency’s medical devices classification.