USPSTF takes broad view on BRCA1/2 testing | Pathologists speak out on celiac | FDA clamps down on genetic tests

Dear LabPulse Member,

Today, the U.S. Preventive Services Task Force published new recommendations on screening and testing for BRCA1/2 mutations in cancer patients in the Journal of the American Medical Association. The task force broadened its guidance regarding which women with breast and ovarian cancer should get screened and tested, and it touted the high sensitivity and wide availability of genetic testing for BRCA1/2 mutations.

The authors of JAMA editorials also published today hailed the recommendations and noted that testing is "woefully underused." Some experts also suggested that the recommendations don't go far enough: For example, they would like to see more information about ethnic subsets of the population who are more likely to have BRCA1/2 mutations and information about testing in patients with other tumor types. Poly (ADP-ribose) polymerase inhibitors have proved effective for ovarian and breast cancer, but they are also being positioned for patients with BRCA-mutated prostate cancer and pancreatic cancer.

In other recent genetic testing news, Myriad Genetics' GeneSight test for screening patients with depression to guide treatment is facing scrutiny by the U.S. Food and Drug Administration (FDA). The company said it is making changes to the way results are reported to providers and faced questions about agency oversight during an earnings call. Myriad's troubles reflect overall greater regulatory attention on genetic tests used to make decisions about medications.

The wide availability of genetic testing and concerns about the effects of gluten in the diet may naturally lead consumers to try to find out if they have celiac disease. A large international study just linked gluten intake in toddlers with a greater risk for celiac disease, which could make consumers even more curious about their status. However, the College of American Pathologists is urging its members to play a more active role in educating clinicians about appropriate testing. For example, genetic screening is not the right test to order upfront.

On the economic front, Bruce Carlson from Kalorama Information, a sister company of, discusses a recent report charting the rise of urgent care centers and explains what the trend means for labs.

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