Luminex (LMNX) Receives EUA for Coronavirus Detection Test

Zacks Equity Research

Luminex Corporation LMNX recently announced that it has received Emergency Use Authorization (EUA) from the FDA for its ARIES SARS-CoV-2 Assay that can rapidly detect the virus causing COVID-19. This development is likely to enable hospital professionals to decide the appropriate course of treatment for patients, who might be infected with COVID-19, within about two hours.

Notably, the assay runs on the FDA approved ARIES System, which is a sample-to-answer, automated, on-demand molecular diagnostic platform. The system has the capacity to run 144 tests daily without any requirement of specialty training and minimal human interaction.

This development is likely to bolster Luminex’s ARIES platform, which represents a major revenue prospect for the company. This way, Luminex can boost the molecular diagnostics platform and strengthen presence in the global infectious disease diagnostics market.

Significance of the Approval

With this approval, Luminex has been able to provide another cost-effective SARS-CoV-2 test to labs and patients who are in desperate need of quick and accurate results. In order to lend support to hundreds of labs across the United States and worldwide, the company is scaling up production of this assay over the next three weeks.

The labs already have the ARIES System in operation and thus have the ability to run the test rapidly as Luminex makes it widely available.



Recent Regulatory Approval

Last month, Luminex announced that it has received EUA from the FDA for its NxTAGCoV Extended Panel that will be used to detect the SARS-CoV-2 virus. Now, high-complexity molecular laboratories can utilize the NxTAG test on Luminex’s easy-to-use, compact MAGPIX System, which will help detect the virus causing COVID-19 for up to 96 patients in about four hours.

Coronavirus Outbreak and Impact

Coronavirus, which was first detected in central China in December, has turned into a full-blown pandemic, and its panoptic impact has left most of the world rattled and shocked. In fact, more than 360,000 people across the United States have been infected with the novel coronavirus, with more than 10,000 losing their lives.

Amid this crisis, some key players have made significant progress with regard to testing in order to check the spread of the pandemic.

Abbott Laboratories ABT recently announced the receipt of the FDA’s EUA for its molecular point-of-care test, ID NOW COVID-19, for the detection of the novel coronavirus. The test, which is the fastest available molecular point-of-care test available to date, can be used in a variety of healthcare settings like physicians' offices, urgent care clinics and hospital emergency departments. The test will provide positive results within five minutes and negative results in 13 minutes.

Also, PerkinElmer, Inc. PKI, announced that it has received EUA from the FDA for its New Coronavirus RT-PCR (Reverse transcription polymerase chain reaction) test. Clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) can start utilizing this test kit to detect SARS-CoV-2 (virus causing COVID-19) immediately. Notably, this test is marketed as an in-vitro diagnostic (IVD) device on basis of fulfilling the requirements of European In Vitro Diagnostic Directive (IVDD). The test kit is now available in over 30 countries worldwide.

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 has been a well-timed one for Luminex.

Price Performance

Over the past year, shares of this Zacks Rank #2 (Buy) company have gained 13.3% against the industry’s decline of 15.9%.

Another Key Pick

Another top-ranked stock from the broader medical space is The Cooper Companies, Inc. COO, which currently carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cooper Companies has a projected long-term earnings growth rate of 10.8%.

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