Bio-Rad Announces U.S. FDA Pre-Market Approval for the BioPlex 2200 HIV Ag-Ab assay, a Novel Next Generation HIV Diagnostic Test
Hercules, CA — July 28, 2015 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced that it has received U.S. Food and Drug Administration pre-market approval to offer its BioPlex® 2200 HIV Ag-Ab assay, the company's 5th generation HIV diagnostic test.
The BioPlex 2200 HIV Ag-Ab assay offers early detection of HIV by detecting HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection). In addition to the early detection offered by other tests, the 5th generation BioPlex HIV Ag-Ab assay provides more information by specifically identifying which individual HIV-1 or HIV-2 marker is positive. This valuable additional information indicates if the patient was recently infected. Early treatment of these patients and outreach to those they may have infected reduces the risk of further transmission.
"Bio-Rad is proud to launch the next generation in HIV diagnostic testing," said John Hertia, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. "Bio-Rad has a long history of providing laboratories the tools that they need for HIV detection and we are pleased to continue offering solutions that offer more value and help curtail the spread of this disease."
During the first six months after infection virus levels are higher and the risk of transmission is greater. With a 5th generation test, clinicians can use the identification of the HIV-1 antigen to help identify patients with early infection, information that is not available using a 4th generation test.
With the FDA pre-market approval, the BioPlex 2200 HIV Ag-Ab assay is approved for organ donor screening and helps in the diagnosis of infection in pediatric subjects as young as two years old and pregnant women.
In its most recently published data, the Centers for Disease Control and Prevention estimates over 1.2 million people are living with HIV/AIDS in the U.S. and there are about 168,300 individuals who are not aware they are infected. Each year there are approximately 50,000 new HIV infections in the U.S. Early detection and treatment of the disease are key to reducing the spread of HIV.
The release of the BioPlex 2200 HIV Ag-Ab assay is the latest offering in the growing infectious disease menu of the BioPlex® 2200 system, the first and only fully-automated, random access multiplex testing system. The BioPlex 2200 system provides clinical laboratories with the capability to rapidly process or "multiplex" multiple individual tests that are traditionally processed separately, conserving patient sample volume and simplifying workflow.
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) develops, manufactures, and markets a broad range of innovative products and solutions for the life science research and clinical diagnostic markets. The company is renowned for its commitment to quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as the biotechnology, pharmaceutical, and food safety industries. Founded in 1952, Bio-Rad is based in Hercules, California, and serves more than 100,000 research and healthcare industry customers through its global network of operations. The company employs more than 7,600 people worldwide and had revenues exceeding $2.1 billion in 2014. For more information, please visit www.bio-rad.com.
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications