FDA clearance

The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.

The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays.

The firm's multi-analyte quality controls for nucleic acid tests are designed to help large and small labs mitigate quality challenges. 

The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.

The M1, a lower-throughput version of the company's Aries System, can process up to six samples and six assays at a time.

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.