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Luminex (LMNX) Files EUA Application for New Respiratory Assay

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Luminex Corporation recently submitted an Emergency Use Authorization application (EUA) to the FDA for the company's new multi-analyte respiratory panel pairing Flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target.

This submission indicates completion of a crucial milestone in a Luminex funding award from the Biomedical Advanced Research and Development Authority (BARDA), which enabled the rapid development and authorization of the assay.

This development is likely to boost Luminex’s molecular diagnostics platform and strengthen presence in the global infectious disease diagnostics market.

More on the Assay

The ARIES Flu A/B & RSV+SARS-CoV-2 Assay can be run on all Luminex ARIES Systems. Notably, the ARIES System is an FDA-cleared, sample-to-answer, automated molecular diagnostics platform developed for use in moderate and high complexity labs.

Luminex developed the combined assay to swiftly deliver clear solutions about respiratory infections from a single test, thereby helping medical teams treat patients with more efficiency. The ARIES Flu A/B & RSV+SARS-CoV-2 Assay can be run on six-unit and 12-unit ARIES Systems with minimal hands-on time, generating results in around two hours.

Importantly, the ARIES Flu A/B & RSV+SARS-CoV-2 Assay is expected to identify new variants of the coronavirus. For investors’ notice, Luminex developed the original ARIES SARS-CoV-2 Assay with financial support from BARDA earlier this year.

Recent Development

In March 2021, the company clinched the FDA EUA for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.

Market Prospects

Per a report published on Grand View Research, the global molecular diagnostics market was valued at $9.2 billion in 2019 and is expected to reach $18.2 billion by 2027, witnessing a CAGR of 9% between 2020 and 2027. Factors like technological advancements in molecular diagnostics and the rising prevalence of infectious diseases are likely to drive the market. Hence, the latest development is time opportune for Luminex.

Price Performance

Over the past three months, shares of this currently Zacks Rank #3 (Hold) company have gained 39.6% compared with the industry’s growth of 0.1%.

Stocks to Consider

Some better-ranked stocks from the broader medical space are Align Technology (ALGN - Free Report) , Abbott Laboratories (ABT - Free Report) and Hologic (HOLX - Free Report) . While Align Technology currently sports a Zacks Rank #1 (Strong Buy), the other two presently carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Align Technology has a projected long-term earnings growth rate of 19%.

Abbott has a projected long-term earnings growth rate of 14.1%.

Hologic has an estimated long-term earnings growth rate of 15.4%.

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