companion diagnostics

Viewing posts tagged companion diagnostics

22 Jun 2017

NGS Companion Diagnostic Approved by FDA

By Jay Goth

The US Food and Drug Administration today approved the first next-generation sequencing-based companion diagnostic that can analyze alterations in a panel of genes predictive of response across three non-small cell lung cancer treatments.

The panel, however, gauges alterations in 23 genes in total. The test report will not only indicate whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of variants in other genes.

This initial approval makes way for Thermo Fisher to quickly expand the indication of the panel into new markers predictive of drug response. The company is actively working with other drugmakers to expand the indications for the Oncomine Dx Target Test.

Read the entire article at Genome Web.

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13 Jun 2017

Predictive Gene Expressions

By Jay Goth

Qiagen has reported that the company and Bristol-Myers Squibb will explore the use of NGS to develop gene expression profiles as predictive or prognostic tools for use with several BMS immuno-oncology therapies. The companies also plan to enter into a further agreement to develop diagnostic products using the jointly developed profiles to expand the use of NGS technology with other BMS immuno-oncology therapies.

“Greater precision in the treatment of cancer may enable faster decision making to identify which patient populations are most likely to derive benefit from our immuno-oncology agents.”

–Fouad Namouni, Bristol-Myers Squibb

This development is an example of the trend towards companion diagnostics, in which the use of predictive biomarkers identify individually-based therapies.
Read the announcement here.

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