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Roche’s diagnostics division has been on a tear in recent weeks, scoring key nods that will also be a boon for fellow pharma giants. 

A companion diagnostic that’s part of Roche’s Ventana product line notched an FDA breakthrough designation in late April for non-small cell lung cancer. The test, which could become the first AI-driven diagnostic approved by the agency for NSCLC, is used to identify patients who’d be a good fit for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Datroway. 

Roche also got the go-ahead this week for a different Ventana lung cancer test that helped enroll patients in a trial for AbbVie’s Emrelis.

Both wins demonstrate the pivotal role diagnostics play in drug development. But a major goal is yet to be scored — a device that can quickly run tests on the spot with a fingerprick draw of blood. Theranos once sought to pioneer that tech, but the company’s leadership lied about its viability and fell from grace. Now, a stealth-mode biotech that happens to be led by former Theranos CEO Elizabeth Holmes’ partner is resurrecting that quest. Today, we’re looking at the new company’s approach and how the blood testing market has changed since Theranos was on the scene. 

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