FDA clearance

It is the first FDA-approved test for the stem cell transplant use case and meets the WHO International Standard for comparable results.

The software connects Luminex's FDA-cleared Aries PCR-based platform with its multiplex xMap technology-based Magpix system.

With this clearance, the respiratory pathogen panel is ready to enter the market to aid in accurate patient diagnosis for respiratory illness. 

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.