Home >> Tag Archives: Bio-Rad Laboratories—

Tag Archives: Bio-Rad Laboratories—

FDA clears digital PCR test for monitoring CML therapy

Feb. 19, 2019—Bio-Rad Laboratories announced that its QXDx AutoDG ddPCR System, which uses the company’s droplet digital PCR technology, and the QXDx BCR-ABL %IS Kit received FDA clearance. The system and kit, when used together, can monitor molecular response to treatment in patients with chronic myeloid leukemia. “Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” ...

Read More »

Bio-Rad’s digital PCR lands CE

March 24, 2016—Bio-Rad Laboratories announced CE IVD marking for its QX200 Droplet Digital PCR System for highly accurate detection and quantification of nucleic acids, aiding clinical decision-making in the treatment of diseases ranging from cancer to transplant rejection and viral infection. One aspect of cancer precision medicine that will be rapidly influenced by the QX200 system is liquid biopsy, Bio-Rad ...

Read More »

Bio-Rad’s Tango Infinity cleared

Jan. 6, 2016—Bio-Rad Laboratories has received FDA clearance to market its Tango Infinity system that automates routine blood typing and screening testing procedures for patients and donors. Introduced in markets outside the U.S. in 2014, the Tango Infinity is next in the series following Bio-Rad’s Tango Optimo system and offers solid-phase and hemagglutination testing methodologies, state-of-the art components, and sophisticated ...

Read More »

FDA clears Bio-Rad’s D-100 A1c test system

Dec. 22, 2015—Bio-Rad Laboratories announced that its D-100 System for A1c testing has obtained clearance from the FDA to monitor the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes, and to help identify those who may be at risk for developing the disease. The D-100 is a fully automated instrument using high-performance ...

Read More »

Newsbytes, 10/15

October 2015—A decade later, online laboratory handbook gets makeover: Ten years ago, when Massachusetts General Hospital created an online laboratory handbook, the event crowned many hours of programming and coding by a team of pathologists, who were convinced their labors would dramatically streamline access to information.

Read More »

Bio-Rad releases allergy test QC controls

Sept. 10, 2015—Bio-Rad Laboratories has released human-serum based Lyphochek Allergen sIgE quality controls to monitor the precision of in vitro allergy test procedures. Lyphochek Allergen sIgE Control (Negative and Panel A) are multiconstituent controls that eliminate the need for multiple, single-analyte controls. The controls are analyzed for 15 frequently tested allergen-specific immunoglobin E antibodies that include dust mites, mold, dander, ...

Read More »

Bio-Rad offers lab quality-control software

Sept. 1, 2015—Bio-Rad Laboratories has launched risk-management software designed to help labs identify the best quality-control rules and the right QC frequency to develop a customized quality control plan and deliver reliable test results. The product—Bio-Rad Mission: Control—uniquely quantifies a laboratory’s risk tolerance, going beyond traditional risk assessments. Using the software, a laboratory is able to establish a QC strategy ...

Read More »

Bio-Rad launches fifth-gen HIV test

Aug. 4, 2015—Bio-Rad Laboratories recently announced the U.S. introduction of the BioPlex 2200 HIV Ag-Ab Assay, a fifth-generation multiplex diagnostic test for use on the BioPlex 2200 automated platform. The Food and Drug Administration has given Bio-Rad premarket approval for the BioPlex 2200 HIV Ag-Ab kit, which is already offered in Europe. The assay is designed to simultaneously detect and ...

Read More »

Bio-Rad offers vitamin D kit for BioPlex 2200

May 8, 2015 —Bio-Rad Laboratories recently launched the BioPlex 2200 25-OH Vitamin D kit for use on the company’s BioPlex 2200 system in U.S. markets. The assay offers a fully automated method for the quantitative measurement of total 25-hydroxyvitamin D in human serum. “We are pleased to extend availability of our BioPlex 2200 25-OH Vitamin D kit to U.S. markets,” Bio-Rad ...

Read More »