The New Diagnostics Companies

A small number of start-ups are developing novel specilalty-focused diagnostics that capture drug-like revenues and margins without taking drug-like development and regulatory risks. Questions about the business model abound, since most companies need multiple tests to reach profitability and a changing regulatory climate may force these companies to seek FDA approval for their tests, dramatically increasing development risk and cost.

By Ellen Foster Licking and Roger Longman

Diagnostics have had an image problem for decades. That's why, when Ken Conway started up a new diagnostics effort at...

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