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FDA Clears Luminex's MDx Respiratory Viral Panel

This article has been updated to include information from a conference call and Luminex's closing stock price.
 
NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared Luminex’s molecular diagnostic panel for a dozen viruses that account for over 85 percent of respiratory viral infections, including various influenza strains, the company said today.
 
The xTAG Respiratory Viral Panel, made by Luminex Molecular Diagnostics in Toronto, is based on Luminex's xMAP technology. The firm had expected to receive FDA clearance of the panel this past fall, but the process took longer than expected, which Luminex CEO Patrick Balthrop in October attributed to the filing being a de novo submission of “the first product of its kind.”
 
Using one swab sample, the xTAG can identify three types of Influenza A, a strain of influenza B, as well as adenovirus, respiratory syncytial virus A and B, Metapneumovirus, Parainfluenzas 1, 2, and 3, and rhinovirus, which causes the common cold. 
 
Current tests for some of these viruses can take several days to provide a thorough diagnosis, the company said.
 
Luminex’s CEO Patrick Balthrop said the FDA’s 510(k) clearance of the test can help improve virus surveillance in and out of the hospital and can “significantly improve patient care.”
 
During a conference call Thursday evening, Balthrop said, “This test has the potential to completely change the way respiratory disease is diagnosed. xTAG RVP offers physicians and patients a level of information to assist them in comprehensive diagnosis that just has not been possible before.”
 
Respiratory viral infections are the seventh leading cause of death in the US, killing 60,000 people per year, and are responsible for 75 percent to 80 percent of doctor visits.
 
The availability of a test for all of these respiratory viruses can both speed up and improve doctor care and could help lower the overuse of antibiotics, which has been implicated in the development of antibiotic-resistant bacteria, the company said.
 
The panel is being sold by LMD and its distribution partner, Thermo Fisher Scientific unit Fisher HealthCare, through an agreement inked last January. It already has the CE mark, allowing the panel to be sold throughout the European Union.
 
The xTAG RVP Panel that has been cleared for sale in Europe has 19 assays as opposed to the 12 on the version cleared here in the US. Luminex had initially been discussing with the FDA including all 19 targets on the product.

“The difference between those roughly seven viruses are viruses that are relatively rare,” Balthrop said during the call. “We cover 85 percent of all respiratory viral infections” in the US in the xTAG RVP Panel, he said.

 
“If we were to add the other seven that are available in the product that has been cleared by European regulatory authorities that number would increase to the low 92 percent range or so,” he added.
 
Balthrop also noted that the RVP panel is the firm’s first molecular diagnostic product to gain FDA clearance since it purchased Tm Biosciences in a $44 million stock-for-stock deal last March and renamed the firm Luminex Molecular Diagnostics.

In Thursday trade on the Nasdaq, Luminex’s shares closed up 4.9 percent at $17.02, after trading as high as $17.87 during the session.

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