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NEWS

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…
February 2, 2026

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…
January 23, 2026

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Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC Oncomine Dx Target Test, first…
November 21, 2025

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Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…
November 12, 2025

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Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…
November 11, 2025

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Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots: The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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Agilent Technologies Reports the US FDA’s Approval of MMR IHC Panel pharmDx (Dako Omnis) as a Companion Diagnostic Test for Colorectal Cancer

Shots: Agilent Technologies has received the US FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) test for colorectal cancer Agilent & BMS partnered to develop the MMR IHC Panel pharmDx (Dako Omnis) to identify dMMR colorectal cancer pts eligible for Opdivo monotx. or Opdivo + Yervoy treatment The…
August 21, 2025

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Viewpoints_Garret Hampton
VIEWPOINTS

Garret Hampton, President, Clinical Sequencing & Oncology at Thermo Fisher Scientific Shares Insights from the Approval of the First NGS-Based Companion Diagnostic for HER2-Mutant NSCLC

Shots: Garret spoke about the approval of the first NGS-based companion diagnostic to aid in selecting NSCLC patients with HER2  activating mutations for treatment with ENHERTU Garret also talked about the Oncomine Dx Target Test and its availability for different targeted therapies in multiple geographies The interview highlights how Thermo Fisher is working to develop accessible CDx solutions…
October 25, 2022

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