FierceBiotech

In a first for companion diagnostics, FDA approves test for use with BioMarin's hemophilia gene therapy

The FDA’s approval on Thursday for BioMarin’s Roctavian gene therapy for severe hemophilia A came with a second approval attached: for a companion diagnostic that can identify which patients may be ...
MedCity News

Siemens will develop companion diagnostics for Pfizer drugs as part of personalized medicine push

Pharmaceutical companies are keen to have a stake in the personalized medicine market, viewed as a growing trend in the future of healthcare and a significant source of life science innovation. As ...
FierceBiotech

NanoString to produce companion test for Celgene's blockbuster cancer drug Revlimid

Seattle's NanoString Technologies ($NSTG) stands to make up to $45 million if it can come up with a successful companion diagnostic test to screen for a subset of ...
Nasdaq

Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first ...
Nasdaq

Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer

Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved companion diagnostic for Zejula in the United States SALT LAKE CITY, March 17 ...
Business Insider

Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer

SALT LAKE CITY, March 17, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced that the U.S. Food and Drug ...