Close Menu

NEW YORK (GenomeWeb) – Myriad Genetics has filed the first module with the US Food and Drug Administration for its rolling premarket approval application for myChoice HRD, a test that drugmaker Tesaro used in studies to identify best responders to its PARP inhibitor niraparib.

However, based on FDA's feedback it's unclear whether the agency will view myChoice HRD as a companion or complementary test.

Get the full story with
360Dx Premium

Only $95 for the
first 90 days*

360Dx Premium gives you:
✔ Full site access
✔ Interest-based email alerts
✔ Access to archives

Never miss another important industry story.

Try 360Dx Premium now.

You may already have institutional access!

Check if I qualify.

Already a 360Dx or GenomeWeb Premium member?
Login Now.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.
Mar
18
Sponsored by
Thermo Fisher Scientific

Viruses mutate as they strive to thrive in response to selective pressures.

Mar
29
Sponsored by
Thermo Fisher Scientific

Global genetic surveillance is vital for understanding the evolution of viral pathogens and monitoring for changes in transmissibility, virulence, disease pathology, and impact on the efficacy of diagnostic tests, therapeutics, and vaccines.

Mar
31
Sponsored by
MilliporeSigma

This webinar will outline the development and commercialization journey of a novel CRISPR-based SARS-CoV-2 test. 

Apr
16
Sponsored by
Thermo Fisher Scientific

With COVID-19 vaccines rolling out, clinical labs and test developers are preparing for changes in both demand for testing and types of testing for SARS-CoV-2.