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Luminex Corporation LMNX recently announced that it has received Emergency Use Authorization (EUA) from the FDA for its xMAP SARS-CoV-2 Multi-Antigen immunoglobulin class G (IgG) Assay. Clinical laboratories can now utilize this serology assay to detect the presence of antibodies in people affected by the virus causing COVID-19. Notably, this is the company’s third COVID-19 test to receive EUA since March 2020.
This development is likely to boost Luminex’s molecular diagnostics platform and strengthen presence in the global infectious disease diagnostics market.
Notably, antibody test identifies prior COVID-19 infection with high specificity and sensitivity in clinical studies. Such tests provide extensive, accurate results while simultaneously reducing the risk of both false positives and false negatives.
More on the Antibody Test
It is important to note here that this antibody test can be run on any of Luminex’s xMAP-based high-throughput, gold standard multiplex platforms. This, in turn, will help in delivering a more thorough and reliable assessment of immune response in comparison to traditional serology testing methods.
Notably, the xMAP SARS-CoV-2 Multi-Antigen IgG Assay has been developed to simultaneously identify antibodies against three antigens. Plus, it delivers high-quality results for up to 96 patient samples in less than three hours.
This antibody test marks the first of the several serology tests, which are being developed by the company with intentions to market with the help of a EUA amid this unprecedented public health crisis.
The new test can be run on all xMAP platforms that includes MAGPIX, FLEXMAP 3D and the Luminex 200.
With more than 17,000 xMAP systems already sold to laboratories around the world, this FDA authorization presents new opportunities for such labs to expand their COVID-19 testing capabilities rapidly with a highly accurate serology-based assay.
In April, the company announced that it has received 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.
In March, the company announced that it has received EUA from the FDA for its NxTAG CoV Extended Panel that can 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.
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.
Over the past year, shares of this Zacks Rank #3 (Hold) company have gained 79.2% compared with the industry’s growth of 13.6%.
Stocks to Consider
Some better-ranked stocks from the broader medical space include Quest Diagnostics Incorporated DGX, West Pharmaceutical Services, Inc. WST and Laboratory Corporation of America Holdings LH. While Quest Diagnostics and Laboratory Corporation sport a Zacks Rank #1 (Strong Buy), West Pharmaceutical carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Quest Diagnostics has an estimated long-term earnings growth rate of 13.2%.
Laboratory Corporation has an estimated long-term earnings growth rate of 7.5%.
West Pharmaceutical has a projected long-term earnings growth rate of 9.2%.
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