Luminex (LMNX) Receives FDA Clearance For XMAP Assay

Shares of Luminex Corporation (NASDAQ:LMNX) have been shining bright lately with a strong one-year return of approximately 12.1%, better than the S&P 500’s 4.9% over the same period.

Meanwhile, the company announced the receipt of Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the xMAP MultiFLEX Zika RNA Assay (xMap).

Following the second-quarter earnings release, the FDA go-ahead closely follows the approval for ARIES Flu A/B & RSV Assay designed for identification and differentiation of ‘Influenza A/B’ and ‘Respiratory Syncytial’ Virus.

Notably, xMAP has been designed by GenArraytion, a partner of Luminex, to exclusively execute multiplex tests that detect Zika virus RNA from the plasma, blood serum or urine of potential patients. We note that the assay has not got any formal clearance from the FDA but has successfully sealed an authorization for being used in the period of high emergency.

The laboratories certified by the CLIA (Clinical Laboratory Improvement Amendments) perform these multiplex tests. The assay has been exclusively structured to detect six genetic targets of the Zika virus by utilizing the Luminex 100/200 or MAGPIX platforms.

Notably, molecular assay is better than other serology assays, as it not only detects multiple Zika targets but is also successful in prompt detection of viral pathogen causing diseases.

We believe the FDA nod for various molecular assays in detection of Zika and Influenza are notable developments for Luminex. In fact, the assays should boost the company’s market position as the molecular diagnostic market is anticipated to grow rapidly at a CAGR of 9.3% and reach $9.3 billion by 2020, as per data from Markets & Markets.

For the long haul, Luminex strategizes to address more patients affected by all kinds of mosquito-borne diseases. In fact, the company is in talks with key public health reference and hospital laboratories to enhance its disease-addressing coverage and thus enhance its treatment decisions.

Meanwhile, stocks that warrant a look in the broader medical sector are NuVasive Inc (NASDAQ:NUVA) , Baxter International Inc. (NYSE:BAX) and Quidel Corp. (NASDAQ:QDEL) .