Bio-Rad Laboratories has secured approval from the US Food and Drug Administration (FDA) for its BioPlex 2200 Lyme Total assay.


Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.

The BioPlex 2200 Lyme Total assay is an advanced multiplex test method, which will be used in the diagnosis of Lyme disease.

Lyme disease is the common tick-borne illness in the US, and most if its signs and symptom are similar to other conditions which make diagnosis complicated.

According to the company, the individuals immediately treated for the disease usually recover rapidly and completely.

BioPlex 2200 Lyme Total assay holds capacity to simultaneously detect multiple targets, enabling laboratories to collect valuable information in the early stages of Lyme disease to facilitate quick treatment for patients.

BioPlex 2200 Lyme Total assay is the latest product in Bio-Rad’s infectious disease menu for the BioPlex 2200 system, which is an automated multiplex technology platform.

The BioPlex 2200 system allows clinical laboratories to rapidly process or multiplex multiple individual tests that are traditionally processed separately, helping to conserve patient sample volume and simplify workflow.

Bio-Rad clinical diagnostics group president John Hertia said: “The addition of the BioPlex 2200 Lyme Total assay broadens our BioPlex 2200 System infectious disease menu, offering laboratories the ability to detect Lyme disease at an early stage and thus fulfilling an important medical need in the management of Lyme disease.”

Based in Hercules of California, Bio-Rad Laboratories is engaged in the development, manufacturing and marketing a range of advanced products for the life science research and clinical diagnostic markets.

Bio-Rad produces IH-Complete family of immunohematology test systems, which include quality controls, competency kits and data management that serve as an effective quality control system.

The company’s customers include university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality.

With revenues of more than $2.2bn in 2018, the company has a global network of operations that employs more than 8,000 people.