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Abbott (ABT) CE-Marked Panbio Test Now Widely Offered in Europe

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Abbott Laboratories ABT recently received the CE Mark for its Panbio COVID-19 Antigen Self-Test for sale directly to consumers. The test, which delivers results in a few minutes, can be used to detect the SARS-CoV-2 virus on symptomatic or asymptomatic (with or without symptoms) adults and children.

For investors’ note, the self-test is already authorized for use in Germany and France as part of national testing programs in schools, universities and workplaces. The Panbio COVID-19 Antigen Rapid Test Device and Panbio COVID-19 Antigen Self-Test are also available in other countries beside the United States, but are subject to local regulatory and commercialization requirements.

The test device for professional use is CE-Marked, and has also received WHO’s Emergency Use Listing for use on asymptomatic individuals and for self-collection of samples using a nasal swab under professional supervision.

It should also be noted that since August 2020, Abbott has shipped 300 million Panbio COVID-19 Antigen Rapid tests for professional use across Europe, the Americas, Asia and Africa.

With the recent regulatory clearance, Abbott aims to fortify its position in the Diagnostic Product business on a global scale.

Significance of the Approval

Rapid antigen testing is less expensive than polymerase chain reaction or PCR testing, thus allowing more frequent testing. As the unrelenting spread of the pandemic has put a check on travel restrictions and increased workplace absenteeism, a test facilitating mass screenings is required.

The over-the-counter approval of the Panbio Self-Test is expected to lead the way for crucial access to fast and reliable self-testing across Europe to check the spread of infection with resumption of economies and daily life activities. Further, regular rapid testing at work, school, home and other facilities enables people to know their infection status. This makes mass screening a vital tool in the mitigation of COVID-19 with the lifting of restrictions and rolling out of vaccines.

The easy-to-use and minimally invasive test is also one of the most widely studied and used rapid antigen tests in the world. The test also has a high accuracy in identifying specimens in its clinical evaluations.

Per management, the regulatory clearance will enable people to be more vigilant in detecting and curbing the spread of the virus and ensure a safer return to daily life activities.

Industry Prospects

Per a report by 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, at a CAGR of 9%. Factors like progress in molecular diagnostics and the growing prevalence of infectious diseases are likely to drive the market.

Given the market potential, Abbott’s Diagnostic Product business is expected to be significantly boosted by the recent regulatory clearance.

Notable Developments

Abbott has witnessed a few notable developments in its Diagnostic Product business over the past few months.

The company, this month, announced a pilot program along with Walgreens, which is included in the United States segment of Walgreens Boots Alliance, Inc. WBA. The program is aimed at increasing access to Abbott's BinaxNOW COVID-19 Antigen Self Tests weekly for Pennsylvania Electronic Benefit Transfer cardholders in the city of Philadelphia at no cost.

Abbott, during its first-quarter 2021 earnings release in April, reported robust worldwide Diagnostics sales, which was driven by demand for the company’s portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms.

The same month, the company began shipping its BinaxNOW COVID-19 Ag Self-Test to retailers across the country.

Price Performance

Shares of the company have gained 27.9% in the past year compared with the industry’s 18.4% rise and the S&P 500 composite’s 39.9% growth.

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Zacks Rank & Stocks to Consider

Currently, Abbott carries a Zacks Rank #5 (Strong Sell).

A couple of better-ranked stocks from the broader medical space are Veeva Systems Inc. VEEV and National Vision Holdings, Inc. EYE.

Veeva Systems’ long-term earnings growth rate is estimated at 15.8%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

National Vision’s long-term earnings growth rate is estimated at 23%. It currently sports a Zacks Rank #1.

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Abbott Laboratories (ABT) : Free Stock Analysis Report

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