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Roche to Acquire PathAI for ~$1.05B

Shots: Roche has entered into a definitive merger agreement to acquire PathAI, building on their 2021 partnership, which scaled up in 2024 to incl. the development of AI-enabled companion diagnostic algorithms As per the deal, Roche will acquire PathAI for $750M upfront & ~$300M in additional milestone payments; closing is expected in H2’26 The acquisition…
May 7, 2026

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant) Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…
May 5, 2026

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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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