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Luminex Files for FDA 510(k) Clearance of RSP Flex Assay

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Zacks Equity Research
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Luminex Corporation LMNX recently submitted an application to the FDA, seeking a 510(k) clearance of the VERIGENE II Respiratory Flex Assay. It is the second VERIGENE II assay to be submitted to the regulatory body.

The VERIGENE II Respiratory Flex (RSP Flex) Assay is a multiplexed, qualitative test designed for simultaneous detection and diagnosis of common viruses and bacteria from nasopharyngeal swabs that are extracted from people most likely to be affected by respiratory tract infection.

Once the regulatory clearance comes through, the company’s Assay portfolio is expected to receive a major boost.

More About the VERIGENE II Respiratory Flex 

This along with the Gastrointestinal (GI) Flex Assay currently runs on Luminex's new VERIGENE II system. The GI Flex Assay is an automated test designed to aid the detection and diagnosis of enteric bacteria, viruses, parasites, and toxins in stool samples.

Both are now currently being reviewed by the FDA and the launch of both the new VERIGENE II assays are being anticipated for mid-2021.

The uniqueness of the automated VERIGENE II System lies in its ability to allow clinical laboratories to select, test and pay for only the targets ordered for each patient.

The RSP Flex Test is performed on the VERIGENE II system by using reverse transcription, polymerase chain reaction, and array hybridization in order to diagnose specific respiratory viral and bacterial pathogen nucleic-acid gene sequences. The VERIGENE II RSP Flex Assay performs a critical test that is developed to address the challenge of widespread respiratory tract infection.

Market Prospects

Per Markets and Markets, the Respiratory syncytial virus diagnostics market is anticipated to reach a worth of $929.2 million by 2022 from $574.3 million in 2017, at a CAGR of 10.1%. Hence, the submission of this assay for FDA approval has happened at an opportune time.

Recent Development

Last year, the company attained regulatory go-ahead for another assay, which has strengthened its diagnostic testing portfolio.

In October 2019, Luminex attained FDA 510(k) clearance for the ARIES MRSA Assay. The assay is an integrated, real-time, polymerase chain reaction-based, qualitative, in-vitro diagnostic test which enables the direct diagnosis of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients who are susceptible to nasal colonization.

Price Performance

Shares of Luminex have dropped 0.9% in the past year compared with the industry’s 3.4% loss.

Zacks Rank & Key Picks

Currently, Luminex carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are ResMed Inc. RMD, Medtronic plc MDT and Hill-Rom Holdings, Inc. HRC.

ResMed has a projected long-term earnings growth rate of 12%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is estimated at 7.4%. The company presently carries a Zacks Rank #2.

Hill-Rom’s long-term earnings growth rate is estimated at 11.1%. It currently carries a Zacks Rank #2.

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