Bio-Rad's (BIO) IH-500 System Secures 510(K) From the FDA

Bio-Rad Laboratories Inc. BIO recently received 510(k) clearance from the FDA for its automated random-access system for blood typing and screening — IH-500.

Bio-Rad is a global pioneer in the field of life science research and clinical diagnostic products. This regulatory go-ahead is in line with the company’s strategy of strengthening in the transfusion medicine market of the United States.

More About IH-500 System

The system, designed to cater to small and medium-sized laboratories, provides automated blood typing and screening services based on the gel card technology. It is equipped to process the entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody identification, single antigen testing, direct AHG testing (DAT) and crossmatch offered by Bio-Rad. The system requires minimal user intervention and delivers safe and precise results.

Bio-Rad has a diverse portfolio of platforms, reagents, data management and connectivity solutions to cater to different blood typing needs. Using Bio-Rad’s IH-Com patient data management software and IH-Web remote results management interface, the IH-500 and other blood typing and screening equipment can be easily integrated into a laboratory setting to enable efficient management of blood testing workload.

Market Prospects

Per Markets And Markets, the global blood group typing market is estimated to reach a worth of $3.12 billion by 2021, at a CAGR of 9.8% in the 2016-2021 period. Considering the abundant market potential, the FDA approval of the IH-500 system is strategically timed.

Recent Regulatory Clearances

Bio-Rad is currently focusing on product innovation and is effectively spending on research and development. In the recent past, the company achieved several regulatory approvals for its broad product line.

Last October, the company received 510(k) clearance from the FDA for the IH-Reader 24, a semi-automated blood typing instrument designed for medium-to small-volume laboratories. Earlier in 2018, Bio-Rad had received 510(k) clearance for the IH-Incubator L and IH-Centrifuge L instruments to be used with the full range of Bio-Rad’s IH-System Gel Reagents for manual blood typing methods. These approvals led to the expansion of the company’s portfolio of blood testing products.

In February 2019, Bio-Rad received FDA clearance for its BioPlex 2200 Lyme Total Assay, an innovative multiplex test method which enables the diagnosis of Lyme disease. This approval expanded the company’s BioPlex 2200 System infectious disease portfolio.

Price Performance

Over the past year, Bio-Rad has outperformed the industry it belongs to. The stock has rallied 23.9%, compared with the industry’s rise of 11.3%.

Zacks Ranks and Other Key Picks

Bio-Rad currently sports a Zacks Rank #1 (Strong Buy).

A few other top-ranked stocks in the broader medical space are Stryker Corporation SYK, Penumbra, Inc. PEN and Amedisys, Inc. AMED. Notably, each of these stocks currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Stryker’s long-term earnings growth rate is projected at 10%

Penumbra’s long-term earnings growth rate is estimated at 20.9%.

Amedisys’s long-term earnings growth rate is projected at 19.7%.