Bio-Rad

The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.

The kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.

The project builds on a collaboration between Bio-Rad and Genetic Analysis using the GA-map clinical test for gut dysbiosis.

An increase in sale growth for its life science segment was offset by a flat quarter year over year for its diagnostics sales.

The instrument is a centrifuge/reader combo that automatically reads and transfers blood type and antibody screening results to patient data management software.

The approach could allow doctors to more accurately and more easily identify which patients are free from cancer after radiation treatment.

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

The company said Q2 sales increased 11 percent on a currency-neutral basis, driven by growth in both its Life Science and Clinical Diagnostics segments.

In June, the FDA cleared tests for a broad range of conditions, including Group B strep, systemic rheumatic disease, and chlamydial or gonococcal urogenital disease.

The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.

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