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Bio-Rad, Biodesix Partner to Get EUA for Coronavirus Test

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Bio-Rad Laboratories, Inc. (BIO - Free Report) announced a collaboration with Biodesix to get an Emergency Use Authorization (EUA) approval from the FDA for Droplet Digital polymerase chain reaction (PCR) (ddPCR) test to meet the escalating testing requirements in the United States under due to the coronavirus outbreak.

Notably, the partnership has been signed after two studies published this month showed that the ddPCR testing provided better outcomes, unlike traditional testing methods that use the qPCR technology. The companies are currently working to get the EUA so that Biodesix can start the tests in the United States at the earliest.

With the partnership, Bio-Rad aims to strengthen its position in the Clinical Diagnostics business globally.

 



 

Rationale Behind the Collaboration

The studies, which have been published ahead of peer review, show that the ddPCR testing method reduces false-negative results of COVID-19, without any increase in false positives. The second study concludes that ddPCR testing significantly improves the diagnostic detection accuracy of SARS-CoV-2, thereby further reducing cases of false negatives. Hence, ddPCR testing could be a powerful complement to the current testing standards.

 



 

Industry Prospects

Per a report by Grand View Research, the global in vitro diagnostics market size was valued at $60.8 billion in 2019, and is expected to witness a CAGR of 4.4% between 2020 and 2027. Factors like the growing adoption of fully automated instruments, automation in laboratories and increasing adoption of point-of-care testing are likely to drive the market.

Recent Developments in Clinical Diagnostics

Of late, Bio-Rad has been working impressively to meet the testing requirements for COVID-19.

In March, the company announced that the performance of its QX200 ddPCR System for the clinical detection of SARS-CoV-2 proved to be more accurate compared to the existing testing procedures that use qPCR. The findings were published in two studies this month, ahead of peer review.

Further, Bio-Rad announced that it is providing its Real-Time qPCR products to testing laboratories worldwide to screen for COVID-19. The products include the company’s CFX Real-Time PCR Detection Systems and reagents such as its Reliance One-Step Multiplex RT-qPCR Supermix.

Bio-Rad further announced the launch of SARS CoV-2 Standard to support laboratory assay authentication of coronavirus testing and accelerate the access to testing through its Exact Diagnostics product line.

Price Performance

Shares of the company have climbed 5.6% in the past year against the industry’s 26% decline.

Zacks Rank & Stocks to Consider

Currently, Bio-Rad carries a Zacks Rank #4 (Sell).

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 7.1%. 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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