Get 40% Off
👀 👁 🧿 All eyes on Biogen, up +4,56% after posting earnings. Our AI picked it in March 2024.
Which stocks will surge next?
Unlock AI-picked Stocks

FDA EUA for Coronavirus Tests Boosts MedTech: 3 Stocks in Focus (Revised)

Published 03/30/2020, 04:41 AM
Updated 07/09/2023, 06:31 AM

The coronavirus pandemic continues to weigh on the global stock market.Most U.S. companies across industry domains have slashed their first-quarter guidance owing to expectations of revenue losses.Last month, a study by The Guardian estimated that the outbreak might cost the global economy more than $1 trillion.

FDA Steps Up Efforts

Amid this crisis, the FDA has been continuously stepping up its efforts to bring swift and efficient solutions, which can bring respite to patients and healthcare professionals. On Feb 29, the FDA decided to allow certain certified laboratories to urgently begin developing validated coronavirus diagnostics, subject to the condition that the test is submitted for review within 15 days to the federal agency.

Several key biotech and molecular diagnostic players received FDA’s Emergency Use Authorization (EUA) for COVID-19 tests, which they have been rigorously working on developing and launching commercially lately. Through this, the federal regulatory body expedited the approval procedure for the companies’ tests so that diagnostic professionals could begin conducting the same in any state health laboratory immediately.

Recently Mesa Biotech attained FDA’s EUA for its point-of-care COVID-19 test.This comes right on the heels of diagnostics firm Cepheid attaining the same for its rapid molecular diagnostic test, Xpert Xpress SARS-CoV-2.

Quest Diagnostics DGX had launched a COVID-19 test service on Mar 9, 2020. This test too attained the FDA’s EUA on Mar 17. As of Mar 23, the company performed and reported results for 106,000 COVID-19 tests.

Hologic HOLX too announced the receipt of the FDA’s EUA for its latest molecular diagnostic test, Panther Fusion SARS-CoV-2 assay, a real-time polymerase chain reaction (RT-PCR) in-vitro diagnostic test, which is intended to be used for the qualitative detection of RNA from the SARS-CoV-2.

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

3 Stocks to Focus On

The following Zacks Rank #3 (Hold) companies have already attained EUA for their newly developed coronavirus tests, banking on which the stocks are currently outperforming the broader industries they belong to. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

PerkinElmer (NYSE:PKI) PKI: This Zacks Rank #3 company recently attained EUA from the FDA for its New Coronavirus RT-PCR 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 more than 30 countries worldwide.

In the past six months, the company’s shares have outperformed the industry.The stock has lost 10.4% compared with the industry’s 12.7% decline.

Abbott Laboratories (NYSE:ABT) ABT:This Zacks Rank #3 global major recently announced the receipt of the EUA from the FDA to use its molecular test RealTime SARS-CoV-2 EUA to detect 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.

In the past year, the company’s shares have outperformed the industry.The stock has lost 6.4% compared with the industry’s 15.5% decline.

3rd party Ad. Not an offer or recommendation by Investing.com. See disclosure here or remove ads .

Thermo Fisher TMO: This Zacks Rank #3 global manufacturer of scientific instruments recently attained EUA from the FDA for its diagnostic test to be used immediately by CLIA high-complexity laboratories in the United States. The test has been developed for the detection of nucleic acid exclusively from SARS-CoV-2. The authorized test utilizes the Applied Biosystems TaqPath Assay technology and has been developed to deliver patient outcomes within four hours of a sample reaching a laboratory. The estimated time-to-result constitutes of time for sample preparation and instrument analysis. The EUA test is optimized for use on the company's Applied Biosystems 7500 Fast Dx Real-time PCR instrument. The instrument is covered under the EUA and is already utilized in clinical laboratories across the globe.

In the past year, the company’s shares have outperformed the industry.The stock has lost 0.6% compared with the industry’s 15.1% decline.

(We are reissuing this article to correct a mistake. The original article, issued on March 27, 2020, should no longer be relied upon.)



Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Quest Diagnostics Incorporated (NYSE:DGX): Free Stock Analysis Report

Hologic, Inc. (HOLX): Free Stock Analysis Report

PerkinElmer, Inc. (PKI): Free Stock Analysis Report

Abbott Laboratories (ABT): Free Stock Analysis Report

Thermo Fisher Scientific Inc. (NYSE:TMO): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.