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Companion Diagnostics: Page 2
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
Foundation Medicine to collaborate with Bristol Myers Squibb on companion diagnostic for solid tumors
By
LabPulse.com staff writers
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
By
LabPulse.com staff writers
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
By
LabPulse.com staff writers
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
By
LabPulse.com staff writers
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
UnitedHealthcare to offer coverage for Foundation Medicine CDx tests for multiple cancer types
By
LabPulse.com staff writers
Both tests can be used to identify patients who may benefit for treatment from specific targeted therapies. UnitedHealthcare’s coverage for the tests will be effective beginning April 1, 2023.
February 9, 2023
Roche, Janssen expand collaboration to develop CDx tests for targeted therapies
By
LabPulse.com staff writers
The collaboration involves numerous companion diagnostics technologies, including immunohistochemistry, digital pathology, next generation sequencing, PCR, and immunoassays.
February 9, 2023
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