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After Two Decades Under PMA, Oncology ISH Companion Tests Get A Lighter Regulatory Path
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Fusion42 · 20 August 2026 · Fusion42 review
The US FDA is easing regulatory requirements for oncology in situ hybridisation (ISH) companion diagnostic tests by shifting them from the premarket approval (PMA) pathway to a lighter regulatory process. This change comes after two decades and is designed to streamline market entry for these tests that guide targeted cancer therapies.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Medtech founders in oncology diagnostics can move faster to market as the FDA reduces the regulatory burden. You should revisit your regulatory strategy now to align with the new pathways and identify quicker routes to approval.
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1 source · 20 Aug 2026
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