Bio-Rad Laboratories Receives FDA Approval for New BioPlex 2200 Lyme Total Assay to Accurately Diagnose Lyme Disease

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on April 2, U.S. local time, Bio-Rad Laboratories, headquartered in Hercules, California, announced that its product, the “BioPlex 2200 Lyme Disease Total Assay,” had received FDA approval. The “BioPlex 2200 Lyme Disease Total Assay” employs an innovative multiplex testing method to help physicians accurately diagnose Lyme disease.

Lyme disease is the most common tick-borne illness in the United States. Accurate diagnosis of Lyme disease is challenging because many of its symptoms resemble those of other conditions. Fortunately, with accurate detection, patients can recover quickly after treatment. Bio-Rad Laboratories has developed the “BioPlex 2200 Lyme Total Assay,” which can simultaneously detect multiple targets, providing valuable reference information for early diagnosis of Lyme disease and enabling patients to receive timely treatment.

On February 15 this year, Bio-Rad Laboratories’ QXDx AutoDG ddPCR System received FDA approval, becoming the first digital PCR product worldwide to be approved by the FDA. Less than two months later, another new product from Bio-Rad Laboratories has gained FDA approval. The newly approved “BioPlex 2200 Lyme Total Assay” is the latest addition to the company’s BioPlex 2200 system.

The BioPlex 2200 System is a multiplex immunoassay platform developed by the company for various infectious diseases, capable of detecting up to 100 multiplexed protein biomarkers. This enables clinical laboratory personnel to “multiplex” and rapidly process multiple single-plex tests, thereby conserving patient sample volume and streamlining workflows.

Bio-Rad Laboratories, founded in 1952, is a global leader in the life sciences and clinical diagnostics markets. With more than 8,000 employees, the company operates a network that provides medical services to over 85,000 research institutions and industry clients worldwide. Its primary customer base includes hospitals, research institutions, commercial laboratories, and application laboratories related to biopharmaceuticals and food safety. In 2018, Bio-Rad Laboratories’ annual revenue exceeded $2 billion.

In addition to its FDA-approved PCR products and BioPlex 2200 assay kits, Bio-Rad Laboratories’ portfolio also includes medical products for cell analysis, DNA extraction, protein analysis, chromatography, and protein sample preparation.

“The BioPlex 2200 Lyme Total Assay expands the range of infectious diseases detectable by our BioPlex 2200 system,” said John Hertia, President of Bio-Rad’s Clinical Diagnostics Group. “The BioPlex 2200 Lyme Total Assay empowers diagnostic professionals to detect Lyme disease at an early stage, thereby addressing unmet medical needs in Lyme disease management.”

To date, Bio-Rad Laboratories has completed two investments and thirteen acquisitions. The two largest acquisitions by value were: the acquisition of medical device company DiaMed Holding for $390 million on May 16, 2007; and the acquisition of biotechnology company QuantaLife for $160 million on October 5, 2011.

(Compiled by Wang Chan)