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Abbott Launches Coronavirus Detection Test After FDA Gives EUA

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Abbott Laboratories (ABT - Free Report) announced the receipt of the Emergency Use Authorization (EUA) from the FDA to use its molecular test RealTime SARS-CoV-2 EUA to detect the novel coronavirus (COVID-19). Notably, the test will run on the company’s m2000 RealTime System.

Abbott is on track to ship 150,000 RealTime SARS-CoV-2 EUA tests to existing customers in the United States. At the same time, the company will coordinate with health systems and government authorities to supply additional m2000 systems per requirement.

With the steps, Abbott aims to strengthen its foothold in the global Diagnostic Products market.

 



 

Significance of the Approval

Per Abbott, its m2000 systems are capable of running high test volumes in a day, thus meeting the increasing demand for testing.

 


 

As soon as the EUA was received, the company started distributing the tests. Notably, it already distributed the tests to hospitals and academic medical center labs in 18 states in the United States, including Illinois, California, New York, Massachusetts and Washington.  It aims to ramp up production capacities to the highest possible level and supply up to 1 million test kits per week by the end of March. Notably, the tests are currently being manufactured in the United States.

Industry Prospects

Per a report published on Grand View Research, the global molecular diagnostics market size 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 as well as the rising prevalence of infectious diseases are likely to drive the market.

Recent Regulatory Approvals

The company received the CE Mark for the new FlexNav delivery system for tits Portico transcatheter aortic valve implantation (TAVI) system in March, thus enabling marketing authorization in Europe.

In February, Abbott received the CE Mark for the Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices. This will likely aid people in Europe, who are suffering from abnormal heart rhythms and heart failure. Further, the company received the Breakthrough Device designation from the FDA for its in-development Fully Implantable Left Ventricular Assist System.

Abbott announced the receipt of the CE Mark for its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system in January. With the approval, TMVI can be used in Europe for treating significant mitral regurgitation in patients that require a heart valve replacement procedure. Further, the company received the FDA’s approval for a new and expanded indication for its Infinity Deep Brain Stimulation system to include the targeting of the internal globus pallidus in the brain.

Price Performance

Shares of Abbott have moved down 0.9% in the past year compared with the industry’s 23.6% decline.

Zacks Rank & Key Picks

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

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

ResMed has a projected long-term earnings growth rate of 14.4%. 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 has 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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