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Prevencio Planning Multi-center Validation to Support FDA Bid for CAD Rule-out Test

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Prevencio, a proteomic diagnostic company working with technology licensed from the University of Pittsburgh, is hoping to begin a multi-center validation study within the next year that will support an application for US Food and Drug Administration approval of its multiplex protein test for ruling out obstructive coronary artery disease in chest pain patients in the emergency room.

The company announced Tuesday the appointment of new President and CEO Rhonda Rhyne, who told ProteoMonitor this week that Prevencio hopes to be able to launch the test, called HART, within the next three years.

The HART test is intended as a rule-out mechanism for patients entering the emergency room with chest pain, Rhyne explained. The company is hoping the test can be used to provide a diagnosis within one or two hours to reduce unnecessary additional testing or invasive and expensive cardiac catheterization.

"Within the niche of chest pain patients who present in the ED, 10 percent have conclusive EKG or troponin tests confirming that they have coronary artery disease and need catheterization," Rhyne said. "But for the other 90 percent, these standard tests are not conclusive."

"Physicians can do what they call serialized troponin testing, and sometimes it will be conclusive, or they might do a coronary CT angiogram, which isn’t as invasive as a normal angiogram, but it's not risk-free. And sometimes they send a patient home, and sometimes they send them to the cath lab anyway, just to be safe. So there is a real need for a better way to safely [and quickly] rule out those who can go home," she explained.

Prevencio's initial panel was based on early biomarker discovery work at the University of Pittsburgh that found a group of 32 proteins able to discriminate patients with CAD from those without. Rhyne said Prevencio has since conducted additional studies narrowing that panel down to a set of 10 of the most predictive analytes, including osteopontin, resistin, VCAM, and MMP7.

The company has also further studied that group of 10 markers, identifying a number of different combinations ranging from two to five proteins that have showed a "very good ability" based on statistical analysis to distinguish patients with CAD who require further treatment, from those who can avoid further testing or invasive treatment, she said.

In a set of slides provided by Rhyne, the company reported that the HART test has 95 percent sensitivity, 60 percent specificity, and an area under the receiver operating characteristic curve of 0.85 in distinguishing patients with CAD from those without.

Currently the company is using a sandwich ELISA for the multiplex test, Rhyne said, but is looking for partners to transition the assay to a different platform ahead of its planned multi-center validation. She did not detail what that new platform might be.

"We are going to be doing a [single-center] validation over the next three to six months, and in parallel we are designing the multi-center trial. Depending on how quickly we can get it done, that study should be launched within the next nine to ten months," Rhyne said.

Several molecular tests focused on diagnosing or predicting coronary artery disease have already entered the market, such as CardioDx's Corus CAD test. But Rhyne said HART will be a cheaper, more rapid assay. CardioDX offers Corus CAD as an LDT out of its own laboratory, which means testing takes several days, she said. HART, as a proteomic test conducted on-site at hospitals, would offer a less costly rule-out for patients in the emergency room setting.

"If someone shows up to the ED, you really need an answer within one or two hours. That's where we fit in," she said.

Rhyne said Prevencio is planning for the first iteration of the test to be run out of a hospital's central lab, offering a result within two hours. Following that, she said that the company hopes to adapt the assay to a point-of-care diagnostic that could be used within just one hour.

According to Rhyne, Prevencio's activities so far have been supported by angel investors, who she said will continue to provide funding as the company moves forward with its validation and FDA approval plans, hoping to launch the test within three years.

"The multi-center study will be pivotal for the FDA," Rhyne said, "So once that is concluded we would hope we would be able to move toward launching the test, but realistically, it will probably be three years out before that happens."

Though the company has IP covering other cardiovascular disease areas, like stroke, Rhyne said Prevencio's current focus is entirely on advancing the HART test.

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