Ischemia Technologies, Inc. (ITI) plans to sell its Albumin Cobalt Binding ( ACB ) test for $30 when it begins a controlled market release in March.

The in vitro blood test gained 510(k) clearance Feb. 14 for use with troponin protein tests and an electrocardiogram to help rule out heart attacks for the roughly 6 mil. Americans who present with chest pains at emergency rooms each year.

The test's list price is comparable with that of B-type natriuretic peptide tests for diagnosing congestive heart failure, and ITI hopes to receive the same $47 reimbursement rate, although the two tests will not compete with each other, according to the firm. ITI is awaiting a CPT code from the American Medical Association.

The ACB test is the "first new blood test for evaluation of heart attacks" since troponin testing was introduced in 1994, FDA notes in a "talk paper."

Because only about 20% of patients presenting with chest pain in the ER are later diagnosed with acute coronary syndromes, the ACB test will be able to further stratify patients who can be safely sent home. A study of 200 high-risk patients supporting the marketing submission showed that the test increased accuracy in ruling out heart attacks to 70% from 50% with ECG and troponin alone.

According to ITI, testing via ECG and biomarkers of cardiac necrosis (troponin, CKMB, myoglobin) can diagnose 12% of patients; an additional 13% of patients can be discharged based on their history and physical findings, leaving 75% of patients in a "gray zone." The company maintains, however, that up to 40% of chest pain patients could be discharged safely within a few hours by adding the ACB test, generating considerable cost savings. Based on the principle that the structure of albumin changes during a heart attack, the test detects Ischemia Modified Albumin by measuring how much cobalt binds to it when added to a blood sample. Results are read on a chemistry analyzer.

Privately held ITI is in the process of hiring a direct sales force and initially plans to target marketing efforts at medical centers that participated in the clinical trial. The effort will expand to other hospitals after the first year. Denver, Colo.-based ITI, which has about 30 employees, also is developing a point-of-care version of the test and a dedicated analyzer.

ITI Test To Help Rule Out Heart Attacks Has $180 Mil. U.S. Market Potential

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