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Navigate BioPharma, Becton Dickinson collaborate on CDx solutions
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
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
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
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
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
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
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
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
Foundation Medicine to collaborate with Bristol Myers Squibb on companion diagnostic for solid tumors
The FoundationOne CDx test would be used in identifying patients likely to respond to treatment with repotrectinib if both the treatment and the test are approved.
April 11, 2023
Oncocyte announces results for gene expression test in colorectal cancer clinical trial
The results, published in Clinical Cancer Research, show that DetermaIO identified more patients who were potentially responsive to immune checkpoint inhibitor treatment than current biomarkers identified.
April 10, 2023
AmoyDx PLC Panel gets Japanese approval as companion diagnostic for NSCLC
The AmoyDx PLC Panel has been approved in Japan for the identification of activating alterations in seven driver genes, including RET, to be used in identifying patients whose NSCLC is likely to respond to treatment with selpercatinib.
March 27, 2023
Servier, Qiagen partner to develop companion diagnostic test for AML
Under a master collaboration agreement, Qiagen will develop and validate a real-time PCR-based in vitro diagnostic test that can be used to detect IDH1 gene mutations in whole blood and bone marrow aspirates in AML.
March 9, 2023
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