Bio-Rad Launches Serology Test to Detect Coronavirus Antibody

Bio-Rad Laboratories, Inc. BIO announced the launch of a blood-based immunoassay kit to detect antibodies stimulated in the human body in response to the SARS-CoV-2 infection. Currently, the kit is undergoing clinical evaluation in various hospitals to further confirm clinical performance after the initial specificity performance of the assay has been established.

Bio-Rad is currently planning to offer the immunoassay kit globally. Notably, the company intends to use the FDA's Emergency Use Authorization (“EUA”) to speed up the availability of the kit in the United States.

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

Significance of the Launch

The human body’s antigen production is stimulated by the viral antigens to fight after being infected by the SARS-CoV-2. Per the company, the kit will enable physicians to identify individuals, who have been infected and have developed an immune response against the SARS-CoV-2.

Per Bio-Rad’s management, a serology test is a better approach for the diagnosis of the coronavirus and screening purposes as it provides a better understanding of the infection rates as well as immunity. The large-scale antibody detection will enable public authorities to decide on containment order status, depending on the serological status of the population.

Further, the kit uses a more sensitive testing approach, unlike most other assays. The test can be used either manually or on an automated immunoassay platform like Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.

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 a collaboration with Biodesix to get a EUA from the FDA for Droplet Digital polymerase chain reaction (PCR) (ddPCR) test to meet the escalating testing requirements in the United States due to the coronavirus outbreak. The partnership was signed after two studies published in the same month showed that the QX200 ddPCR System provided better outcomes, unlike traditional testing methods that use the qPCR technology.

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

In March, 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 31% in the past year against the industry’s 7.9% decline and the S&P 500’s 4.9% fall.

Zacks Rank & Key Picks

Currently, Bio-Rad carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are ResMed Inc. RMD, National Vision Holdings, Inc. EYE and Integra LifeSciences Holdings Corporation IART.

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.

National Vision’s long-term earnings growth rate is estimated at 10.7%. The company presently has a Zacks Rank #2.

Integra’s long-term earnings growth rate is estimated at 11.9%. It currently carries a Zacks Rank #2.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.