Bio-Rad Laboratories

Hercules,  CA 
United States
http://www.bio-rad.com/diagnostics

• Booth: 3239

Bio-Rad Laboratories is a leading global clinical diagnostics and life sciences company. We are focused on meeting the diagnostic testing needs of our customers in all areas of the hospital and reference laboratories. Bio-Rad delivers on this commitment by offering a broad portfolio of quality products backed by superior service. Bio-Rad holds leadership position in diabetes monitoring, quality control (QC) system, autoimmune testing, HIV test systems, blood bank reagents and instrumentation.

 Press Releases

• Bio-Rad Receives U.S. FDA Clearance for the IH-500, Expanding Its Offering for the Blood Testing Market (Apr 17, 2019)

  HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Bio-Rad’s IH-500, an automated random access system for blood typing and screening.

  The IH-500 system was designed for small- to medium-size laboratories, offering automated blood typing and screening based on gel card technology with minimal user intervention. The system can process Bio-Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing (DAT), and crossmatch, to deliver safe and accurate results.

  “We are pleased to receive FDA clearance for our IH-500 and look forward to extending our reach in the U.S. transfusion medicine market,” said John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics Group. "This addition rounds out our offering, specifically benefitting mid and smaller volume laboratories using gel technology to test blood in an automated way,” he said.

  Bio-Rad offers a wide variety of platforms, reagents, data management, and connectivity solutions to address different volume 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 Bio-Rad blood typing and screening instruments can be seamlessly integrated to help laboratories to more efficiently manage their blood testing workload.

  Bio-Rad is a trademark of Bio-Rad Laboratories, Inc. and IH-500 and IH-Com are trademarks of Bio-Rad Europe GmbH in certain jurisdictions

• Bio-Rad Announces Innovative Test to Aid in the Diagnosis of Lyme Disease with the FDA Clearance of the BioPlex 2200 Lyme Total Assay (Apr 17, 2019)

  HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its BioPlex 2200 Lyme Total Assay, an innovative multiplex test method to aid in the diagnosis of Lyme disease.

  Lyme disease is the most common tick-borne illness in the United States. Many signs and symptoms of the disease are similar to other conditions so diagnosis can be challenging; however, individuals immediately treated for the disease usually recover rapidly and completely. The BioPlex 2200 Lyme Total Assay can simultaneously detect multiple targets, providing laboratories valuable information in the early stages of Lyme disease so patients are able to receive treatment as quickly as possible.

  “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,” said John Hertia, Bio-Rad President, Clinical Diagnostics Group.

  The release of the BioPlex 2200 Lyme Total assay is the latest offering in Bio-Rad's infectious disease menu for the BioPlex 2200 System, an automated multiplex technology platform. The BioPlex 2200 System provides clinical laboratories the capability to rapidly process or "multiplex" multiple individual tests that are traditionally processed separately, conserving patient sample volume and simplifying workflow.

  Bio-Plex and Bio-Rad are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions

• Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response (Apr 17, 2019)

  HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products to receive U.S. Food and Drug Administration (FDA) clearance. Used together, Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).

  “Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” said Annette Tumolo, Bio-Rad EVP and President, Life Science Group. “The QXDx AutoDG ddPCR System and QXDx BCR-ABL %IS Kit represent the first-ever digital PCR solution that can monitor and directly quantitate the molecular response of patients with chronic myeloid leukemia under tyrosine kinase inhibitor therapy.”

  CML is a cancer of white blood cells that is characterized by a fusion of the BCR and ABL genes. Tyrosine kinase inhibitor (TKI) therapy has transformed CML into a manageable chronic disease for many patients. The current standard for monitoring treatment response in patients with CML is using reverse transcription quantitative PCR (RT-qPCR), but this method can produce variable results, particularly when measuring low levels of the disease. Using the QXDx BCR-ABL %IS Kit, clinicians can accurately and reproducibly monitor residual disease in patients with CML, even at low levels, offering physicians better insight into the management of this disease.

  The QXDx AutoDG ddPCR System is designed to be flexible, allowing users to run either FDA-cleared in vitro diagnostic tests or lab developed tests on the platform.

  Bio-Rad introduced Droplet Digital PCR (ddPCR) technology to the market as a research tool in 2012, and it was quickly adopted in clinical cancer research for liquid biopsy and rare mutation detection. The portfolio of ddPCR products offers reproducible, absolute quantification with precision, sensitivity, and a scalable workflow. To date, there are more than 3,400 publications citing Bio-Rad’s ddPCR technology, including more than 900 publications focused on liquid biopsy.

  Bio-Rad, Droplet Digital, ddPCR, and QuantaSoft are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions