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First Of Its Kind DNA Test Can Assess Predisposition for Dozens of Cancer Types

By LabMedica International staff writers
Posted on 03 Oct 2023
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Image: The US FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel (Photo courtesy of Invitae Corporation)
Image: The US FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel (Photo courtesy of Invitae Corporation)

Cancer is a disease marked by uncontrolled cell growth that can spread to other parts of the body, and there are over 100 different kinds known to us. Now, an in vitro diagnostic test has the ability to detect hundreds of genetic variants that could indicate a higher likelihood of developing specific kinds of cancer. Additionally, this test can identify hereditary genetic variants in those who have already been diagnosed with cancer.

Invitae Corporation’s (San Francisco, CA, USA) Invitae Common Hereditary Cancers Panel is a diagnostic test that examines 47 genes related to cancers of the breast, ovary, uterus, prostate, and the digestive system, including the stomach, colon, rectum, small bowel, and pancreas. The test analyzes DNA from a blood sample to identify variants in these 47 genes, which are known to increase the risk of these cancers. The panel aims to provide a comprehensive diagnosis for people who have a personal or familial history of mixed cancers affecting these organ systems. The insights gathered from this test can confirm a diagnosis and also assist in making treatment and management plans. If the test uncovers a variant known to cause the disease, it can also help in screening family members who may be at risk.

To conduct this prescription test, a blood sample is collected from the patient in a healthcare setting like a doctor's office and then sent to a lab for examination. The clinical interpretation of these genetic mutations is based on evidence from scientific publications, public databases, predictive software, and Invitae's in-house database of curated genetic variants. The analysis adheres to guidelines set by reputable professional bodies. Some of the most clinically important genes that this test can identify include BRCA1 and BRCA2, which are linked to hereditary breast and ovarian cancer syndrome, genes associated with Lynch syndrome (MLH1, MSH2, MSH6, PMS2, and EPCAM), CDH1 (mainly related to hereditary diffuse stomach cancer and lobular breast cancer), and STK11 (connected to Peutz-Jeghers Syndrome). This test has received de novo marketing authorization from the U.S. Food and Drug Administration, making it the first of its kind to get such an approval.

"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, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Today's action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants."

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