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The New Diagnostics Companies

This article was originally published in Start Up

Executive Summary

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.
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