Companion Diagnostics

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

UnitedHealthcare to offer coverage for Foundation Medicine CDx tests for multiple cancer types

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

The collaboration involves numerous companion diagnostics technologies, including immunohistochemistry, digital pathology, next generation sequencing, PCR, and immunoassays.

February 9, 2023

Guardant360 CDx breast cancer liquid biopsy test receives FDA approval as companion diagnostic

The Guardant360 CDx blood test uses genomic profiling to identify patients with ESR1 mutations who may benefit from Orserdu therapy.

January 30, 2023

Qiagen obtains FDA approval for NSCLC companion diagnostic assay

Therascreen KRAS is a tissue-based polymerase chain reaction (PCR) assay designed to identify NSCLC patients likely to respond to treatment with Mirati Therapeutics’ Krazati (adagrasib).

December 13, 2022

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AmoyDx PLC Panel gets Japanese approval as companion diagnostic for NSCLC

Invivoscribe files for FDA approval for acute myeloid leukemia CDx

The filing supports Daiichi Sankyo's new drug application (NDA) for quizartinib for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML. The application has been granted Priority Review status by the FDA.

October 24, 2022

Tempus, Kartos Therapeutics collaborate on CDx for Merkel cell carcinoma treatment

The collaboration is aimed at developing a companion diagnostic (CDx) test to identify patients with TP53 wild-type (TP53WT) Merkel cell carcinoma (MCC) who may be responsive to treatment with navtemadlin.

October 7, 2022

Roche gets FDA approval for metastatic breast cancer CDx

The Pathway anti-HER2 (4B5) test is now FDA-approved for use in the assessment of metastatic breast cancer patients who may be eligible for Enhertu, an HER2-directed antibody drug conjugate.

October 4, 2022

Nucleai, Propath partner on immuno-oncology panel

Propath will develop a novel protocol using the Lunaphore Comet platform for analysis of 30 high-value protein targets from a single tissue section. The platform enables rapid development of highly multiplexed panels, with robust and reproducible staining, Nucleai said.

September 20, 2022

Qiagen, Neuron23 to develop CDx for Parkinson’s

Under the agreement, Qiagen will develop and validate a clinical trial assay that will detect a combination of biomarkers discovered by Neuron23 that together predict the responsiveness of Parkinson's disease to a LRRK2 inhibitor.

September 13, 2022

Foundation Medicine, Relay Therapeutics to collaborate

RLY-4008 is a work-in-progress oral small-molecule inhibitor of FGFR2, which is part of a set of proteins that can mutate into diseases such as cholangiocarcinoma, according to Foundation Medicine. Under the collaboration, FoundationOne CDx would be used to help clinicians identify patients with FGFR2 mutations and select those who could benefit from treatment with RLY-4008.

September 11, 2022

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