Unmet Need, Actionable Results, Clinical Utility: 3 Non-Negotiables for New Diagnostics

Originally published on MedCityNews.com.

Originally published on MedCityNews.com.

There are thousands of genetic test products on the market today, and more being introduced all the time. As targeted drugs and personalized medicine become reality, the diagnostics market has become a welcoming place for startups.

That doesn’t mean the market has room for every new kind of test, though. “Having great science is a good place to start,” said Dr. Mark Monane, the chief medical officer of molecular diagnostics company CardioDx. “It’s not a good place to finish.”

CardioDx’s flagship product is Corus, a lab-based blood test to help physicians rule out obstructive coronary artery disease in patients presenting with suggestive symptoms. Chest pain and shortness of breath, for example, can be symptoms of CAD. But they can also be signs of gastrointestinal, psychological or musculoskeletal conditions.

As a physician by training, a former managing director of equity research at Needham & Company and the CMO of a commercial-stage company, Monane shared a few crucial qualities a diagnostic test must have in order to find traction in today’s market.

Fundamentally, the diagnostic needs to address a clear unmet need. “If it just gives (doctors) more confidence, or lets them check another box, that makes it hard to convince anyone to pay for it,” Monane said. The value for CardioDx’s test was reducing unnecessary referrals to cardiologists and diagnostic tests, which result in excessive costs and exposure to radiation for patients.

The 23-gene expression test is also sex-specific, taking into account the differences between how coronary artery disease presents in men and women, something other diagnostic mechanisms for CAD don’t do, Monane said.

Secondly, the diagnostic needs to produce actionable results. Clinicians must understand when to use it and what the results will tell them. It must demonstrate that it can peform accurately, conveniently, reliably and safely, Monane said.

Third, physicians must be able to incorporate it into their clinical decision-making. In CardioDx’s 430-patient study (PDF), 46 percent of patients who presented with suggested symptoms but tested below the risk threshold did not require additional diagnostic screening. Monane said this provided evidence that the results were influencing physicians’ decision-making and reducing the number of unnecessary referrals.

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