Before patients receive the Cotellic/Zelboraf combination, patients should be tested with an FDA-approved BRAF mutation companion test, the agency said.
The German molecular diagnostics firm has adjusted its 2015 outlook in response to the FDA letter.
The complementary diagnostic for Bristol-Meyers Squibb's Opdivo is the firm's second test to receive FDA approval this month. The first was for Merck's Keytruda.
The test is for determining whether a patient's tumor expresses the PD-L1 protein and is likely to respond to Merck's drug Keytruda, which the FDA also approved today.
The test was approved for use with Iressa to determine those patients who would benefit by being treated with the drug.
Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology.
The Group B Strep test is the second test on the firm's menu granted clearance, and is intended for screening pregnant women.
The agency also categorized the test as moderate complexity, which will allow some clinicians to perform the test directly.
The test is the second assay on the Alere i molecular platform, which was previously CLIA waived to run a flu test.
The company is focusing on hematological malignancies and looking to partner with pharmaceutical companies for companion diagnostics.
In PLOS this week: Mycobacterium abscessus linked to gastric conditions, placental gene expression changes associated with preterm birth, and more.
The Guardian reports that UK universities are looking into ways to reduce labs' reliance on single-use plastics.
MIT's Technology Review reports on a company's genetic test that gauges an embryo's susceptibility to certain diseases.
People with certain gene variants tend to not like vegetables, particularly bitter ones, CNN reports.