NEW YORK (360Dx) – New Jersey-based HealthCheck Diagnostics aims to commercialize an ELISA test that people could take during routine doctors' visits, or whenever they are experiencing chest pain, to assess the risk of getting a heart attack.
"By looking at the inflammatory response of the body to atherosclerotic disease, the test will be able to stratify the risk of a heart attack in a clinically relevant way," said Henry Joseph Runge, an administrator in the tech transfer office of the University of Nebraska Medical Center, which exclusively licensed its atherosclerotic test to HealthCheck.
By finding out definitively whether they may be at heightened risk for a heart attack, more people would seek testing for atherosclerotic disease, Runge said, adding they would be even more likely to take a test if it's more affordable than the current standard of care, which HealthCheck aims to address with its technology.
He added that the buildup of plaque in arteries begins far earlier than some people think, and without testing, it can lead to heart failure in people without symptoms.
The key to HealthCheck's test is a malondialdehyde-acetaldehyde adduct (MMA) biomarker. When malondialdehyde and acetaldehyde react, they form hybrid protein adducts. In 2014, researchers at UNMC published the results of a study in the journal PLOS One, indicating that MAA biomarkers could provide a basis for detecting atherosclerotic disease.
Specifically, they noted that IgM, IgG, and IgA anti-MAA-human serum albumin antibody isotypes are "differentially and significantly" associated with non-obstructive coronary artery disease, acute myocardial infarction, or obstructive multivessel coronary artery disease, and "may serve as biomarkers of atherosclerotic disease."
Virtually everyone who is more than 20 years old has plaque buildup in their coronary arteries, Runge noted, adding that, "It's not a question of if you have atherosclerotic disease, it's more a question of whether you have a disease that's going to gradually progress through your life and leave you with some intermittent chest pain when you are an older person, or it's the kind of condition that is going to be unstable and…give you a heart attack."
By looking for the presence or absence of these pro-inflammatory molecules, he said, the UNMC researchers were able to predict patients at risk for developing heart attacks from those who were not..
Runge noted that UNMC has had inquiries about the biomarker test from "a couple of major diagnostic companies." However, it was difficult for the inventors to put together the type of data needed to "advance the project," he said, until it collaborated with Academic Technology Ventures, a firm that specializes in licensing technologies developed in universities and government laboratories, and which launched HealthCheck Diagnostics around the middle of 2016 to bring the MMA biomarker diagnostic test to market.
"Now that HealthCheck has a business model wrapped around the opportunity," it gives the executives an option to revisit some earlier conversations, he added.
Academic Technology Ventures CEO Jason Pottinger said that the venture company is confident that there is broad market potential for use of the biomarker in a diagnostic test.
The firm expects to raise capital to take its proof of concept through additional clinical trials with "a greater number of patient samples," Pottinger said.
Coronary artery disease is a problem not only for older people, he said, but also for people in their 20s and 30s. However, because of the expense involved, they often get tested when it's already too late and they are experiencing chest pain prior to a possible heart attack, he added.
What's needed, Pottinger said, is an inexpensive, quick test that can be completed for hundreds, rather than thousands, of dollars and that could eventually be incorporated into routine physician exams.
The HealthCheck test would be conducted initially in a laboratory, but the firm also envisions its eventual use in a clinic at the point of care, he said.
James Hurwitz, a clinical general surgeon in daily practice who is cofounder of HealthCheck with Academic Technology Ventures founder Corey Park, said that the firm hoped to launch an in vitro diagnostic test "that's better than or could replace the current standard of care, which is drawing three troponin levels, eight hours apart, over 24 hours."
"When people walk into an emergency room with chest pain, we expect that we will be able to tell them within an hour that they either have a heart problem or there's something far less serious," he said, adding that, "Getting an answer quicker might also save the healthcare system some money," by sending people with less serious conditions home quickly after a test result, rather than keeping them in observation for 24 hours.
The inventors at the University of Nebraska Medical Center have successfully tested the biomarker in 400 patient samples, which was a contributing driver to its interest in commercializing the technology, Pottinger said.
The test's UNMC inventors Daniel Anderson, a cardiologist and researcher, and Geoff Thiele, a professor of internal medicine, had been studying MAA for many years. Thiele had been working on identifying molecules that are disease related and associated with oxidative stress since the 1990s. His interest, then, was in developing a test that identified alcohol liver disease and differentiating liver damage from other inflammatory responses. That led to the identification of MMAs as "immunological distinctions on molecules that have been oxidized," Runge said.
During the past two years, Thiele began working with Anderson, who, based on his research, viewed the accumulation of plaque associated with atherosclerotic disease as an inflammatory process.
The researchers at UNMC adapted the diagnostic test that Thiele had been working on and conducted the prospective study that was published in PLOS One.
What comes next will come down to the selected commercial play, Runge said, and HealthCheck is keeping several options on the table. One is to try to get to market quickly by creating a fee-for-service laboratory test, he said.
HealthCheck Diagnostics and Academic Technology Ventures would use the funding that they hope to raise to build a CLIA-certified laboratory. Or they could, alternatively, collaborate with a laboratory that already has CLIA certification, Pottinger said.
He said that he expects it could take HealthCheck about a year after a successful capital raise to begin earning revenues through a CLIA-certified lab. Longer term, it could pursue US Food and Drug Administration clearance. In the meantime, he noted, the firm will also consider obtaining regulatory approvals to launch the test in China and Europe.
HealthCheck will face stiff competition in the atherosclerotic disease diagnostic space. The Mayo Clinic markets a biomarker test that has been cleared by the FDA. Its chemiluminometric immunoassay measures troponin I, running on Siemen's Advia Centaur XP instrument.
Troponin I is released into the bloodstream within hours of the onset of symptoms of myocardial infarction or ischemic damage, and it can be detected at 3 to 6 hours following onset of chest pain, according to the Mayo Clinic.
Also, in March, proteomic diagnostic firm Prevencio and collaborating researchers published a study in the Journal of the American College of Cardiology that indicates the company's protein test for obstructive coronary artery disease could significantly outperform existing tests for the condition.
The firm is developing an assay kit for a study it plans to launch next year to generate data for an FDA submission, and it plans to open a $20 million Series C funding round in the second quarter of this year to fund the assay kit development and FDA study.
Its test for coronary artery disease measures the quantity of four proteins — adiponectin, apolipoprotein C-1, kidney injury molecule-1, and midkine.
Singulex, another company developing a test for cardiac care, received the CE mark in Europe for its Sgx Clarity immunodiagnostics system, which uses single-molecule counting as a basis of its in vitro diagnostics system.
The firm has also said that it is expanding the clinical testing of its Sgx Clarity automated immunodiagnostics system at four European clinical research sites to evaluate its utility in cardiac care. And earlier this year, the company said it was developing a point-of-care instrument and planned to have a prototype by the end of the year.