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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
Foundation Medicine enters companion diagnostic collaboration with Merck KGaA
By
LabPulse.com staff writers
The agreement builds on a partnership the firms entered in 2020 to accelerate the development of novel targeted therapies.
June 5, 2023
Tempus granted FDA premarket approval for colorectal cancer CDx
By
LabPulse.com staff writers
The NGS test detects substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status.
May 1, 2023
Veracyte announces data for prostate cancer classifier in micrometastatic disease
By
LabPulse.com staff writers
The published data show that the Decipher Prostate scores for patients with high-risk and very high-risk disease were highly correlated with the upstaging predictions by a clinically-validated algorithm.
April 17, 2023
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