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coronary artery disease

The Finnish diagnostics company is working to expand US and European sales of its ceramide lipid-based cardiovascular risk assessment assay, CERT.

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

The company has been focused on commercializing its technology for heart attack assessment, but the new data shows how it could be used for CAD risk, as well.

Investigators came up with a 182-variant risk score for early-onset coronary artery disease, which they tested on SNP data from UK Biobank participants with or without the condition.

Since it launched CADscor, which could compete against molecular tests, in the second quarter, Acarix has announced clients in Germany, Denmark, and Sweden.

The test is the first offered for the Sgx Clarity system, a fully automated in vitro diagnostic platform leveraging single-molecule counting technology.

The firm has settled on a set of metabolite biomarkers, along with an algorithm, for its first version of a test for arterial plaque buildup.

The company plans to open a $20 million Series C round in Q2 of this year and launch a study to support a US Food and Drug Administration submission in mid-2018.

The developer has presented clinical results that provide a base for completing development of a multi-protein test kit and conducting a clinical trial in advance of FDA submission.  

Theranos CEO Elizabeth Holmes speaks at the AACC 2016 meeting

At the American Association for Clinical Chemistry meeting, Theranos CEO Elizabeth Holmes said her company is working on third-party review and publications of the firm's technologies and tests.