Business Wire

Inotrem Secures Strategic Licensing Agreement for a Companion Diagnostics Test in Septic Shock

PARIS--(BUSINESS WIRE)--Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic ...
The American Journal of Managed Care

First-of-a-Kind Companion Test for Cancer Gene Profiling Gets FDA Approval

The FDA has approved Foundation Medicine's FoundationOne CDx, the first-of-a-kind comprehensive companion diagnostic test for solid tumors. The test looks for hundreds of cancer genes, providing ...
GEN

Companion Diagnostics for Cancer

Will NGS Play a Role? Companion diagnostics (CDx), in vitro diagnostic devices or imaging tools that provide information essential to the safe and effective use of a corresponding therapeutic product, ...
GEN

bioMérieux to Design Companion Test for Ipsen Breast Cancer Compound

Assay will predict which patients are best suited to the therapeutic that targets the steroid sulfatase enzyme. bioMérieux agreed to develop a companion test for Ipsen’s Phase I breast cancer drug ...
FierceBiotech

Foundation Medicine nabs 19th companion Dx approval, for Novartis' aspiring breast cancer blockbuster Piqray

Foundation Medicine received a new companion diagnostic approval from the FDA for its FoundationOne CDx test—the product’s 19th indication, now for selecting breast cancer patients for treatment with ...
FiercePharma

FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer

The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most ...
technologynetworks

bioMerieux and Ipsen Sign Theragnostics Agreement to Develop Companion Test for new Breast Cancer Treatment

bioMerieux and Ipsen announced that they have signed an agreement by which bioMerieux will develop a companion test for a new breast cancer drug undergoing clinical evaluation by Ipsen. The ...
RAPS

FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics

The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) ...
Business Wire

CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ ...

ALPHARETTA, Ga.--(BUSINESS WIRE)--CSI Laboratories, a nationally renowned laboratory specializing in comprehensive cancer diagnostics, today announced that it has added the newly approved VENTANA ...
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 ...
Monthly Prescribing Reference

Companion Dx Test for Iressa Receives Marketing Approval

Qiagen announced that it has received marketing approval from the Food and Drug Administration (FDA) for its therascreen EFGR RGQ PCR Kit as a companion diagnostic to Iressa (geftinib; AstraZeneca) ...