Close Menu

NEW YORK – Personal Genome Diagnostics said today that it has received an Investigational Device Exemption (IDE) approval from the US Food and Drug Administration for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy. 

Elio tissue complete, a 507-gene NGS test that detects all classes of gene alterations and also reads out measures of microsatellite instability and tumor mutation burden, is being used in the trial to direct patient enrollment and stratification.

To read the full story....

...and receive Weekly News bulletins.

Already have a Precision Oncology News or 360Dx or GenomeWeb account?
Login Now.

Don't have a Precision Oncology News or 360Dx or GenomeWeb account?
Register for Free.

Feb
11
Sponsored by
Foundation Medicine

In this session, the first in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling has identified biomarkers related to homologous recombination deficiency and DNA damage repair.

Feb
25
Sponsored by
Foundation Medicine

In this session, the second in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review cases in which patient genomic profiles exhibit common driver mutations in tumor types considered “off label” for targeted therapies associated with those mutations.

Mar
11
Sponsored by
Foundation Medicine

In this session, the third in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling has identified gene fusions that may or may not serve as druggable targets.

Mar
25
Sponsored by
Foundation Medicine

In this session, the fourth in the Precision Oncology News Virtual Molecular Tumor Board Series, our expert panelists will review patient cases in which genomic profiling identified no clear molecular markers to help guide personalized therapy.