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Genetic Tests and FDA

FDA will convene a public meeting next week to hear from companies that make direct-to-consumer genetic tests, before it begins an overhaul of its regulations on genetic diagnostic testing, MIT's Technology Review says. FDA says doctors need help interpreting results from these tests, and that a third party should assess them before they are sold to the general public. "More than 2,000 genetic tests are now available through clinical laboratories," Technology Review's Emily Singer writes. FDA has made moves towards regulation of these tests in recent years, she adds, but the issue gained widespread notice in May when Pathway Genomics said it was going to sell its DTC genetic tests at Walgreens. (Walgreens called off the deal under FDA pressure, as our sister blog The Sample noted.) "The agency says it plans to take a risk-based approach, meaning that tests linked to major medical decisions will be more tightly regulated than those that might predict a minor increase in risk for disease," Singer says.

The Scan

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.