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Prevencio Launches Clinical Trial Business, Targets End of Year for LDT Cardio Test Release

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NEW YORK (360Dx) – Proteomic diagnostics firm Prevencio has released a research-use-only version of its HART cardiovascular biomarker panels and is planning to launch laboratory-developed tests for predicting the presence of obstructive coronary artery disease (HART CAD) and predicting major adverse cardiac events (HART CVE) in either late 2018 or early 2019.

The company also this week presented data at the American Diabetes Association 2018 Scientific Sessions demonstrating that its HART CAD and HART CVE tests are as effective in diabetic patients as in patients without diabetes.

Additionally, Prevencio is planning to launch this summer and fall external validation studies for the CAD and CVE tests and for its test for diagnosing peripheral artery disease, called HART PAD. In all, the company has developed six proteomic panels around cardiovascular health, the CAD, CVE, and PAD test, as well as panels for determining the severity of aortic valve stenosis (HART AS), for identifying the risk of amputation (HART AMP) and another test it has not publicly discussed but that Rhonda Rhyne, Prevencio's president and CEO said it has submitted for consideration for a presentation at the 2018 American Heart Association meeting.

The company has been working to commercialize some version of these tests since at least 2013. At that time, Prevencio was planning a multicenter validation study for a proteomic test for ruling out obstructive coronary artery disease in chest pain patients in the emergency room with an eye toward submitting the test for US Food and Drug Administration clearance and a launch in 2016 or 2017.

That launch did not occur, with Prevencio instead continuing its research and test development efforts primarily through a collaboration with James Januzzi, professor of medicine at Harvard Medical School and a cardiologist at Massachusetts General Hospital. Januzzi is the principal investigator on the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study, which has driven much of Prevencio's recent test development work. In that study, Januzzi and his colleagues obtained blood from 1,251 patients undergoing diagnostic coronary angiography in the Mass General cath lab and then followed them for a mean of four years for cardiovascular events including stroke, non-fatal myocardial infarction, and cardiovascular death.

The data on diabetic patients the company presented this week came from this study, Januzzi said, noting that the results suggest the CAD and CVE test could prove useful in this patient population, which is at elevated risk for cardiac issues.

"Patients with diabetes have an increased risk for development of coronary artery disease compared to patients without diabetes, and of course they are at higher risk for major adverse cardiovascular events," Januzzi said. "So on the one hand, one might expect that any diagnostic or prognostic tool might perform at least equally well if not better in patients with diabetes. But on the other side of the coin is that the very signals that make some of these markers abnormal might be even louder in patients with diabetes who don't suffer events — it might attenuate the performance. So, it was an important question to look at."

In the data presented this week, the CAD panel identified diabetic patients with coronary artery disease with an area under the curve of 0.81, a positive predictive value of 90 percent, and a negative predictive value of roughly 60 percent, Januzzi said. The CVE panel predicted one-year risk of a major adverse cardiovascular event with an AUC of 0.80, a PPV of 50 percent, and an NPV of 90 percent. Both tests, he said, performed as well in diabetic patients as in the larger CASABLANCA study cohort.

The results also highlighted diabetes patients' increased risk of cardiovascular events, he said, noting that diabetes patients with an elevated CVE score had a 50 percent one-year risk of an event, compared to a 20 percent one-year risk for non-diabetic patients with elevated CVE scores.

"The potential here for a clinical application is quite substantial both from a diagnostic perspective, to predict presence of coronary disease in a very high-risk patient population, as well as to prognosticate [one-year risk of events] in those patients," Januzzi said.

He added the tests could also be potentially useful for clinical trials investigating diabetes drugs, allowing researchers to, for instance, enrich their trials with individuals at the highest risk of suffering a cardiac event.

Clinical research first

The clinical research market is Prevencio's most immediate target for its tests generally. Rhyne said the company launched its RUO panels on March 1, targeting them for use for clinical trial enrichment and for monitoring drug efficacy. She said the company has received one order for the RUO panels thus far.

In addition to building out its RUO business, Prevencio is launching external validation studies of the CAD, CVE, and PAD tests. The CAD and CVE study will look at around 1,500 patients at two centers, while the PAD study will look at between 300 and 400 patients at three sites. Rhyne said the company plans to complete those studies by the end of the year and launch LDT versions of those tests in late 2018 or early 2019.

She said that with regard to in vitro diagnostic versions of its tests, Prevencio plans to either license the panels to an IVD firm that could develop and bring those products to market or sell them outright. She added that Prevencio was also open to acquisition by a company interested in its tests.

Rhyne said the company is currently funded by "high net worth angel [investors]," and that it had sufficient funds to support the external validation trials for the CAD, CVE, and PAD tests.

"Once we have results from those trials, we will be either looking for corporate venture investment or some other type of financing if we need additional funds to continue to move forward," she said.

Prevencio had said in 2017 it planned to open a $20 million funding round, but Rhyne said this week that it chose to launch its RUO services business first with the aim of producing revenue and increasing its valuation.

"In the interim, we did a $4 million convertible note financing," she said.