In September, the US Food and Drug Administration (FDA) stepped into the laboratory-developed tests sphere again, with a letter sent to Pathway Genomics of San Diego. The agency expressed concern that the diagnostics company was marketing an unapproved genetic test—CancerIntercept Detect—directly to consumers. Under guidance issued by the FDA in 2014 (Nat. Biotechnol. 32, 855, 2014), certain genetic tests defined as class 2 devices require regulatory review. Pathway Genomics claims that because it runs CancerIntercept Detect in a CLIA-certified laboratory, the test does not require review. The genetic test is purported to detect cancer in the blood (a so-called liquid biopsy) of people at high risk for the disease but who have yet to have a diagnosis. It probes circulating DNA for 96 variants in nine cancer driver genes, such as BRAF and EGFR. But the FDA points out that existing literature has detected these markers only in cancer patients. In marketing directly to consumers—albeit with an option to consult a company physician—Pathway ignores all the signals the FDA has sent out in recent years about direct-to-consumer (DTC) marketing of genetic tests (Nat. Biotechnol. 32, 1, 2014). This is not Pathway's first encounter with the agency. In 2010, Pathway pulled plans to market genetic test kits through US pharmacy chain Walgreens after the FDA sent cease and desist letters to five DTC genetic test providers including Pathway. The biotech was given 15 days to respond. In other news, Theranos, a low-cost, direct-to-consumer blood diagnostics company based in Palo Alto, California, at the request of the FDA, has stopped using its undisclosed 'nano-scale testing system' in all but one of its offered clinical assays. This took place after agency inspections of the companies facilities revealed problems.

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