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Acarix Positions Acoustic Test for Ruling out CAD as Alternative to Invasive Methods

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NEW YORK (GenomeWeb) – Acarix recently began placing its CADScor system with European laboratories, marketing the acoustic diagnostic as a noninvasive first-line test for ruling out coronary artery disease for patients presenting with chest pains.

Since it launched CADscor in the second quarter, Acarix has announced clients in Germany, Denmark, and Sweden. Earlier this month, the cardiology department at Skåne University Hospital in Lund decided to introduce the test, which has been cleared for clinical use in Europe since 2015.

CEO Søren Rysholt Christiansen said that CADscor, which relies on acoustic detection to monitor patient's arteries for the telltale turbulence associated with CAD, is an alternative to the conventional stress tests and invasive angiographies used to diagnose CAD.

"The current diagnostic pathway actually has significant room for improvement, because 90 percent of the patients that are seeking medical care don't actually have CAD, and there is no device on the market to rule out these patients early on in the diagnostic pathway," he said. "Our solution is acoustic detection of turbulence in the blood flow, combined with algorithms that enable the rule out of CAD in patients with absolutely no invasive testing."

The test could also be considered as competitive against molecular tests, such as gene expression panels, that are designed to detect markers associated with the disease.

"We offer a result in two minutes, but a gene expression test could take up to three days," said Christiansen. He also said that CADscor, which has an approximate cost of €20 ($23) per test, would likely be competitive with any of the molecular tests on the market or in development.

"Another issue that could be prohibitive for gene expression tests, especially if you talk reimbursement, is the price point," he noted.

Many test developers have gone the molecular root to address the issue of catching, or ruling out, CAD early, however. CardioDx's Corus CAD, for instance, uses a 23 gene, real-time PCR-based panel to help physicians rule out CAD in patients. Prevencio, meantime, has developed an assay called HART CAD that can identify patients at high risk of CAD who should undergo more invasive testing.

While Acarix also caters to hospitals in need of better first-line tests to rule out, or confirm, CAD, the Danish company's approach is quite different from those selling molecular tests. Spun off from the Danish medical technology firm Coloplast in 2009, Acarix has worked for the past eight years on perfecting its acoustic device. Its technology is based on the principle of monitoring normal cardiac contraction movements, which generate lower-frequency sounds, and turbulence in the flow of blood caused by obstruction, which create higher-frequency sounds.

Once attached to a patient's chest, Acarix's CADscor system records, processes, and displays the patient's results as a score on the device's screen. Based on these scores, patients are stratified into three risk categories. Those with a lower risk can typically be sent home, while those with higher risk scores will advance into more intensive screening.

While most patients are currently put through the conventional diagnostic pathway, Christiansen claimed that roughly half of those who present with symptoms of chest pains can be ruled out on the basis of CADscor. That, in turn, should reduce costs associated with the diagnosis of CAD.

"We have a negative predictive value of 97 percent," said Christiansen. "Obviously that translates into economic gains if you can avoid expensive, downstream diagnostic tests."

In addition to its placement at Skåne University Hospital, Acarix has placed CADscor systems at a private cardiology clinic in Berlin, as well as Herning Hospital in Denmark.

David Erlinge, a professor of cardiology at Lund University and head of the cardiology department at Skåne University Hospital, said he decided to adopt the device for ruling out CAD because "noninvasive methods should always be step one." Erlinge added that the hospital's aim by using CADscor is to "ensure that only the patients that need to be referred to further, appropriate diagnostic tests get them and that patients with symptoms unrelated to CAD do not."

According to Christiansen, Acarix, which is headquartered just north of Copenhagen in Kongens Lyngby, has decided to initially focus on building its customer base in Scandinavia and Germany.

The company, which currently employs a dozen people, sells directly in those markets, and is trying to establish a "solid local footprint" while it eyes other markets, Christiansen said. While its operations are run from Denmark, the company's legal parent company is in nearby Malmö, Sweden. Acarix also recently opened a German subsidiary, Christiansen noted.

Last December, it began trading on Nasdaq's First North Premier market in Stockholm. According to Christiansen, Acarix has a current market capitalization of about €45 million. All of this is a turnaround from just a year ago, when the company was still private and mainly backed by local venture firms Seed Capital and Sunstone Life Science Ventures.

"In the past year, we have transformed from being a development company to being a commercial company," Christiansen said. Looking ahead, Acarix aims to win over more customers in its target markets, and to refine its test algorithms based on their feedback. Christiansen said that Acarix currently has data from 2,600 tests in its database.