Skip to main content
Premium Trial:

Request an Annual Quote

Asuragen Gets CE Mark for QuantideX BCR-ABL Kits on Roche Platform

NEW YORK (GenomeWeb) – Asuragen announced today it has expanded its CE mark on two BCR-ABL tests to enable their use on a Roche platform.

The multiplexed qPCR tests are part of the firms QuantideX portfolio and support therapy cessation for long-term responders to tyrosine kinase inhibitor therapies.

The tests include the QuantideX qPCR BCR-ABL IS Kit, which identifies major (e13a2, e14a2) fusions and was granted premarket approval by the US Food and Drug Administration in 2016, as well as the QuantideX qPCR BCR-ABL minor kit for identifying minor (e1a2) BCR-ABL fusion transcripts in patients with chronic myeloid leukemia.

Both tests are currently CE marked to run on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument. The new designation expands their use to the Roche Diagnostics Cobas z 480 Analyzer.

"Making our BCR-ABL portfolio compatible with the 7500 Fast Dx and Cobas z 480 platforms will help ensure that we can serve even more patients around the world," Matthew McManus, Asuragen's president and CEO said in a statement.

The Scan

Less Than Half

An effort to reproduce key findings from high-profile preclinical cancer studies finds less than half could be replicated, according to the Scientist.

Still Some SARS-CoV-2 Sequencing Holes

The Wall Street Journal reports that viral genomic surveillance has improved in the US, though says there are still gaps.

Avoiding Passing Them On

People with known disease-linked genetic variants are turning to in vitro fertilization so as to not pass those variants to their children, the Washington Post says.

PNAS Papers on Long Cell-Free DNA in Maternal Plasma, Genetic Propensity for Voting

In PNAS this week: long, cell-free DNA of maternal and fetal origins identified in maternal plasma, and more.