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companion diagnostics

PharmaDeviceNews companion diagnostics
Representative image: A pathology specialist reviews PTEN biomarker staining as NeoGenomics launches an FDA-approved companion diagnostic to identify prostate cancer patients who may be eligible for AstraZeneca’s Truqap.
Medical Devices & Diagnostics

How the NeoGenomics PTEN IHC test supports targeted prostate cancer treatment

NeoGenomics launches an FDA-approved PTEN IHC companion diagnostic to identify prostate cancer patients eligible for AstraZeneca’s Truqap.

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Representative image of a modern pathology laboratory where automated PD-L1 cancer diagnostic testing is supporting faster immuno-oncology treatment decisions, reflecting Agilent Technologies’ expanded FDA approval for PD-L1 IHC 22C3 pharmDx on the Dako Omnis platform.
Medical Devices & Diagnostics

Agilent wins FDA backing to move more Keytruda-linked PD-L1 testing onto Dako Omnis

Find out how Agilent’s expanded PD-L1 test approval could change automated cancer diagnostics and oncology lab workflows.

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Medical Devices & Diagnostics

What Natera’s Signatera CDx approval changes for adjuvant Tecentriq use in bladder cancer

MRD testing just crossed into treatment selection. Natera’s Signatera FDA win could reshape adjuvant bladder cancer care.

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Representative image: Roche’s $1.05bn PathAI acquisition highlights how AI-powered digital pathology could accelerate tissue analysis, companion diagnostics, and precision oncology workflows across modern diagnostics laboratories.
Medical Devices & Diagnostics

What Roche’s $1.05bn PathAI move reveals about the future of pathology labs

Roche wants AI pathology at scale. PathAI gives it the tissue-analysis layer needed to tighten diagnostics, trials, and precision oncology.

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Pharma & Biotech

How Agilent’s PD-L1 companion diagnostic now shapes pembrolizumab access in esophageal carcinoma

FDA approves Agilent's PD-L1 IHC 22C3 pharmDx for esophageal and GEJ carcinoma, marking the eighth companion diagnostic indication alongside pembrolizumab. Read the analysis.

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Pharma & Biotech

Myriad Genetics expands precision oncology role with Zejula companion diagnostic approval

Myriad Genetics secures FDA approval for MyChoice CDx in ovarian cancer. Discover how HRD testing could reshape PARP inhibitor treatment decisions.

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Medical Devices & Diagnostics

Guardant Health and Merck sign global deal to co-develop cancer companion diagnostics

Guardant Health and Merck announce global CDx collaboration using Infinity Smart liquid biopsy platform. Find out what this means for oncology drug development.

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Medical Devices & Diagnostics

Can Sanyou Biopharmaceuticals and KanryBio Biotechnology disrupt the global companion diagnostics market?

Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. and Wenzhou KanryBio Biotechnology Co., Ltd. have entered into a strategic collaboration focused on co-developing high-value reagents and products for biomarker assay kits. Announced on December 10, 2025, this partnership aims to combine Sanyou Biopharmaceuticals’ global leadership in AI-driven molecular discovery with KanryBio Biotechnology’s capabilities in kit product development and

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