FDA clearance

The test is used to identify NSCLC patients for whom treatment with Tarceva in first-line therapy and Tagrisso in second and subsequent lines of therapy may be effective.

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.