Geenius HIV-1/HIV-2 Supplemental Assay Press Release

Date: 
11/21/14

Bio-Rad's Geenius™ HIV-1/HIV-2 Supplemental Assay detects and differentiates circulating antibodies to HIV Types 1 and 2

HERCULES, CA – November 24, 2014 – Bio-Rad Laboratories, Inc.'s (NYSE: BIO and BIOb) Geenius HIV-1/HIV-2 Supplemental Assay can differentiate circulating antibodies to Human Immunodeficiency Virus Types 1 and 2 in whole blood, serum and plasma. Earlier this month, the company announced that it received Premarket Application Approval from the U.S. Food and Drug Administration for the assay.

The Geenius HIV-1/HIV-2 Supplemental Assay, a faster and easier alternative to Western Blot and an objective alternative to the company's Multispot HIV-1/HIV-2 Rapid Test, offers a three-step procedure that produces clear, onscreen results in 30 minutes with full traceability. The Geenius Reader can then analyze and interpret reaction results for HIV-1 (p31 HIV-1 polymerase peptide, gp160 HIV-1 recombinant protein envelope, p24 HIV-1 recombinant protein core, and gp41 Group M and O HIV-1 peptide envelope) and for HIV-2 (gp 36 and gp 140 HIV-2 peptide envelope).

In designing the Geenius HIV-1/HIV-2 Supplemental Assay, Bio-Rad developers worked closely with the Centers for Disease Control and Prevention (CDC) to ensure the assay would align with the second step of the HIV testing algorithm that the CDC recommended in June 2014.

"We are pleased to receive the FDA Premarket Application Approval for what we consider to be a great improvement in HIV diagnostic testing," said Patrice Deletoille, Bio-Rad Vice President and General Manager, Infectious Disease Division.

Key Benefits:

  • Minimal training required – the clinician simply needs to dispense 15 µl of whole blood or 5 µl of serum/plasma into the cassette well, add 2 drops of buffer, wait 5-7 minutes, and then add 5 drops of buffer into a second well. After 20 minutes, the user can insert the cassette into the Geenius Reader for the automatic reading and interpretation.
  • Qualitative interpretation – interpretation of six individual HIV-1 and HIV-2 band results is provided along with a permanent record of the results and an image of the cassette. The data can later be uploaded to a Laboratory Information System.
  • User-friendly graphical interface – the interface on the notebook computer displays results of the interpretation of the six bands once the cassette is inserted into the reader. A unique 2D barcode on the cassette, read by the Geenius software, positively identifies each cassette, allowing the result and the patient ID to be recorded on a single document.

About Bio-Rad
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 7,800 people worldwide and had revenues exceeding $2.1 billion in 2013. For more information, please visit our website at www.bio‑rad.com.

This release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally can be identified by the use of forward-looking terminology such as, "believe," "expect," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. For further information regarding the Company's risks and uncertainties, please refer to the "Risk Factors" in the Company's public reports filed with the Securities and Exchange Commission, including the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. The Company cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. Bio-Rad Laboratories, Inc., disclaims any obligation to update these forward-looking statements.

Press Contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communicatons
510-741-6063
tina_cuccia@bio-rad.com