Companion Diagnostics

FDA approves Illumina IVD kit as CDx

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology Comprehensive cancer biomarker IVD kit for use as a companion diagnostic to match patients to two targeted therapies, Bayer's Vitrakvi and Lilly's Retevmo.

August 27, 2024

Thermo Fisher gets FDA 510(k) clearance for HLA typing CDx

By LabPulse.com staff writers

Thermo Fisher's SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra for synovial sarcoma.

August 7, 2024

Tempus introduces HER2 and FOLR1 tests for solid tumor cancers

By LabPulse.com staff writers

Precision medicine firm Tempus has launched two new tests to help identify patients with HER2- or FOLR1-expressing tumors who may be eligible for targeted therapies such as antibody-drug conjugates.

June 3, 2024

Pillar Biosciences gets FDA approval for NGS solid tumor profiling test

By Matt Limb

Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.

April 26, 2024

Roche's breast cancer CDx receives CE Mark

By LabPulse.com staff writers

Roche has received the CE Mark for the first companion diagnostic (CDx) test to identify patients with HER2-low metastatic breast cancer who may be eligible for treatment with Enhertu.

April 10, 2024

Qiagen, Myriad Genetics to collaborate on cancer companion diagnostics

By LabPulse.com staff writers

Qiagen and Myriad Genetics have formed a new master collaboration agreement on the development of companion diagnostic tests for cancer.

October 27, 2023

ProciseDx receives FDA de novo authorization for therapeutic drug monitoring tests

By LabPulse.com staff writers

ProciseDx has received U.S. Food and Drug Administrtion (FDA) de novo marketing authorization for its point-of-care tests for monitoring levels of infliximab and adalimumab in patients being treated for inflammatory bowel diseases.

October 5, 2023

Navigate BioPharma, Becton Dickinson collaborate on CDx solutions

By LabPulse.com staff writers

Navigate BioPharma and Becton Dickinson have formed a strategic collaboration to use flow cytometry to develop and commercialize companion diagnostics (CDx) and clinical decision-making solutions.

September 11, 2023

Amoy Diagnostics, AstraZeneca partner on CDx for lung cancer therapy

By LabPulse.com staff writers

This agreement is the latest in ongoing collaborations to develop and commercialize AmoyDx assays for companion diagnostic use with AstraZeneca's prostate, breast, and ovarian cancer therapies.

August 16, 2023

Foundation Medicine wins FDA approval for companion diagnostic to prostate cancer treatment

By Nick Paul Taylor

FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations. The ability of the product to test for alterations and select gene rearrangements and genomic signatures has led to its approval as a CDx for multiple products.

August 16, 2023

TScan teams with Tempus to develop companion diagnostic for cancer cell therapy

By Nick Paul Taylor

The biotech firm TScan has identified Tempus as a company that can help it select the right treatments for patients. Tempus is the developer of xT CDx, a companion diagnostic that the FDA approved earlier this year.

July 11, 2023

With pilot program, FDA seeks to reduce risks of LDTs that identify cancer biomarkers

By LabPulse.com staff writers

The agency said it has become increasingly concerned that some companion diagnostic tests made by laboratories that it has not authorized may not provide accurate and reliable test results.

June 20, 2023

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