Companion Diagnostics: Page 4

CAP issues guideline to improve immunotherapy treatment
By Dexter Johnson
The CAP guideline is evidence-based and joins a small number of testing methods based on both the methodology and the status of the biomarker -- i.e., microsatellite testing and deficient mismatch repair process assessment. This stands in contrast to previous guidelines that focused on the cancer type or tumor origin.
August 4, 2022
2022 08 05 17 07 3161 Antibody Immunotherapy 400
Exact Sciences subsidiary nabs FDA clearance for CDx
By LabPulse.com staff writers
The CDx confirms variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
June 29, 2022
2019 05 22 19 44 5254 Dna Red Laser 400
Akoya, Acrivon to develop CDx for cancer treatment
By LabPulse.com staff writers
OncoSignature identifies cancer patients likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy that Acrivon is developing.
June 28, 2022
2019 11 04 21 37 0904 Ovarian Cancer 400
Biocartis, AstraZeneca to develop CDx for EGFR TKI treatment
By LabPulse.com staff writers
The firms aim to obtain applicable premarket notification or approval from the U.S. Food and Drug Administration (FDA) for a CDx test on Biocartis' fully automated molecular Idylla platform.
June 21, 2022
2019 09 09 20 46 2283 Lung Cancer 400
CDx Diagnostics, Avalon ink in-network lab agreement
By LabPulse.com staff writers
The agreement makes CDx's diagnostic platform, WATS3D, available to the 565,000 members of BCBS of South Carolina, including all of its commercial and Medicare Advantage plans.
June 13, 2022
2021 04 27 15 25 5437 Pathology Digital Workstation Microscope 400
Foundation Medicine gets FDA nod for NSCLC CDx
By LabPulse.com staff writers
Rozlytrek is a targeted therapy for the treatment of non-small cell lung cancer (NSCLC) developed by Roche's Genentech.
June 8, 2022
2019 10 09 17 32 0093 Dna Cancer Cell 400
Grail, AstraZeneca to collaborate on companion diagnostic tests
By LabPulse.com staff writers
The firms will focus first on developing CDx tests using Grail's methylation platform to identify and recruit patients with high-risk, early-stage cancer for AstraZeneca's clinical studies.
June 1, 2022
2019 08 12 20 23 3708 Lab Blood Centrifuge 400
Illumina wins new indication for TruSight Oncology in Europe
By LabPulse.com staff writers
Launched in March initially in Europe, TruSight Oncology Comprehensive (EU) assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer, according to the company. The CDx pan-cancer indication will enable identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2, or NTRK3, and who may benefit from targeted therapy with Bayer's Vitravki (larotrectinib) drug.
May 24, 2022
2020 07 08 21 27 3457 Cancer Maze 400
Agilent secures CE-IVD Mark for cervical cancer test
By LabPulse.com staff writers
PD-L1 is an antibody expressed by cervical cancer tumors and is a key biomarker for predicting response to anti-PD-L1 therapies like Keytruda, according to Agilent. The company's PD-L1 IHC 22C3 pharmDx companion diagnostic identifies cervical cancer patients with a PD-L1 combined positive score of one or more, which indicates that they could benefit from treatment with Keytruda, the company said.
May 10, 2022
2019 11 07 23 47 6944 Squamous Epithelial Cells Cervical 400
Foundation Medicine nabs FDA clearance for NSLC diagnostic
By LabPulse.com staff writers
The test received FDA clearance in February for identifying patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab (Keytruda) treatment. FoundationOne CDx can now also be used as a companion diagnostic to identify patients with NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations.
March 17, 2022
2019 10 09 17 32 0093 Dna Cancer Cell 400
Guardant wins new clearances in Japan for liquid biopsy test
By LabPulse.com staff writers
The MHLW has cleared Guardant360 CDx for mutation profiling in patients with advanced solid tumors. In addition, it approved Guardant360 CDx as a companion diagnostic for identifying patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab (Keytruda). What's more, Guardant360 CDx has also been approved for patients with MSI-High advanced colorectal cancer who may benefit from nivolumab (Opdivo).
March 14, 2022
2022 03 08 19 56 8772 Clearance Stamp 400
FDA clears Foundation Medicine's companion diagnostic
By LabPulse.com staff writers
Characterizing these tumors helps clinicians identify patients who could benefit from immunotherapy such as Keytruda, a humanized antibody used in cancer immunotherapy, the company said. MSI-H status is a defining feature of colorectal, endometrial, and gastrointestinal cancers.
February 22, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
Previous Page
Page 4 of 12
Next Page