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Abbott's (ABT) Diagnostics Arm to Gain From New & Updated EUAs

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Abbott (ABT - Free Report) has hit the headlines following the announcement of the receipt of the FDA’s Emergency Use Authorization (EUA) for the company’s Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. The latest development is expected to boost the company’s Diagnostics arm.

Per the company, this test will play a vital role in the current situation as these viruses have similar symptoms but require different treatment approaches.

Notably, the Alinity m Resp-4-Plex molecular assay is CE Mark approved.

The Test at a Glance

The Alinity m Resp-4-Plex molecular test, which will run on Abbott's Alinity m system, will be conducted with one swab specimen (anterior nasal or nasopharyngeal). Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. This provides automation and on-demand access. Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and critical-care labs due to the pandemic.

Usefulness of the Test in COVID-19 Times

The Alinity m Resp-4-Plex molecular test will allow all the four aforementioned viruses in one test. Based on just one swab sample, this assay will detect and differentiate the viruses simultaneously and will also simplify sample collection hazards. This is crucial particularly during the time of pandemic when demand for such tests is so high. We expect this test to increasingly contribute to the company Diagnostics arms sales in the coming months.

Alinity m Includes Asymptomatic Cases

The company also announced that its Alinity m SARS-CoV-2 test has received updated EUA for asymptomatic usage. More specifically, Alinity m SARS-CoV-2 test will now detect COVID-19 in individuals who do not have symptoms. According to Abbott, per a recent study, currently more than 60% of COVID-19 infections are present as asymptomatic cases. Accordingly, this test is going to play a vital role in detecting asymptomatic cases before they spread further. Going by the ongoing pandemic situation, this test too is expected to witness strong market demand.

ABT’s Molecular & Rapid Diagnostics Grow Path Amid Pandemic

Abbott has developed and launched several COVID-19 tests across its testing platform for both laboratory and rapid point-of-care settings. In March, the company launched two COVID-19 tests — the ID NOW COVID-19 molecular test (the fastest available molecular point-of-care test delivering results within 13 minutes and positive results in five minutes) and the RealTime SARS-CoV-2 molecular test, which runs on Abbott's m2000 RealTime System located in hospitals and reference laboratories.

In addition to molecular testing during this period, the company also anticipated increased demand for other types of tests, including both antigen and antibody. In October, the company received EUA for the its AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT and Alinity platforms. The company also launched BinaxNOW rapid antigen test, which can detect COVID-19 infection in just 15 minutes with no instrument required. In April 2020, the company rolled out its serology blood test for the detection of the antibody, IgG, on its lab-based immunoassay testing platforms.

Abbott’s last-reported fourth-quarter 2020 performance was led by its diagnostics business. Sales grew nearly 110% in the quarter with $2.4 billion contribution coming from COVID testing-related sales. The biggest contribution in the fourth quarter came from rapid lateral flow test to detect the virus, which includes BinaxNOW in the United States and Panbio internationally.

Price Performance

Shares of the company have gained 52.2% in a year’s time compared with the industry’s growth of 27.6%.

Zacks Rank and Key Pick

Currently, Abbott carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are Envista Holding Corporation (NVST - Free Report) , Owens & Minor, Inc. (OMI - Free Report) and Meridian Biosciences Inc. , each carrying a Zacks Rank #1 (Strong Buy). You can seethe complete list of Zacks #1 Rank stocks here.

Envista has a projected long-term earnings growth rate of 24%.

Owens & Minor has a projected long-term earnings growth rate 61%.

Meridian Biosciences has an estimated long-term earnings growth rate of 49%.

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