Medical Device Daily

In its continuing R&D activities, the diagnostics divison of Abbott Laboratories (Abbott Park, Illinois) said last week that it has entered a licensing agreement with the Cleveland Clinic (Cleveland) for the development of an automated in vitro diagnostic test to detect myeloperoxidase (MPO), an enzyme found in white blood cells.

Abbott said that detecting elevating, circulating levels of MPO may be useful in determining a person's risk for adverse cardiac events such as a heart attack.

“The Cleveland Clinic's expertise and research in heart disease is well-known, and we are pleased to enter into this agreement,“ said William Brown, PhD, vice president, diagnostic assays and systems development at Abbott. “Heart disease is a major cause of death worldwide, and Abbott is committed to developing new cardiac diagnostic tests that could improve the diagnosis and treatment of patients with cardiovascular diseases.“

The company said that research conducted at the Cleveland Clinic and published in the Oct. 23, 2003, issue of The New England Journal of Medicine linked elevated MPO levels with the risk of heart attack. More than 600 patients presenting with chest pain in the emergency department were evaluated. MPO was identified as a strong predictor for major adverse cardiac events over the following 30-day to six-month period.

The authors of the study concluded that MPO's link to inflammation in coronary arteries from unstable plaque could make it a potential biomarker useful for risk stratification in patients presenting with chest pain.

“Today, cardiac diagnostic tests already influence how treatment recommendations are made,“ said Stanley Hazen, MD, PhD.

Hazen is head of the Section of Preventive Cardiology and Cardiac Rehabilitation at the Cleveland Clinic.

Under the agreement, Abbott obtained non-exclusive rights to the Cleveland Clinic's existing technologies relating to MPO as a risk indicator for cardiovascular disease. Abbott also maintained worldwide rights to commercialize products using the technology. PrognostiX, an affiliated company of the Cleveland Clinic, will provide as-needed support during the development process.

Other terms of the agreement were not disclosed.

With that agreement, Abbott was casting an eye toward the future. But in late January, it reported that it had completed its cardiac panel, for which it introduced its first test, creatine kinase-MB (CK-MB) last July. The company reported that it received a 510(k) clearance from the FDA for a myoglobin test for use on its Architect i2000 Immunoassay System and Architect ci8200 Immunochemistry System.

Myoglobin is a protein found in muscles, and its levels rise quickly following trauma, such as a heart attack. Abbott said that monitoring these levels would help physicians in the early diagnosis of a heart attack and help in evaluating the success of thrombolytic therapy. Another protein marker test, Troponin-I, was added last August (Medical Device Daily, Aug. 20, 2004).

At that time, Carl Trippiedi, senior product manager in global marketing, told Medical Device Daily, “We have a strategy to be, and are striving to be, a leader in cardiac diagnostics.“

Of the three markers, troponin was considered the most important addition to the panel, since myoglobin is ordered by physicians less frequently, an Abbott spokeswoman said. However, all three markers provide information to a physician who is attempting to diagnose a patient presenting with chest pain.

On a separate system, Abbott's AxSYM automated immuno-assay instrument system also provides a cardiac menu of tests: B-type Natriuretic Peptide (BNP), Troponin-I, CK-MB, which was added last fall (MDD, Oct. 25, 2004), and Myoglobin.

Dan Stredler, senior marketing manager, integrated systems, at Abbott, told MDD that the company's “goal is to get all of those markers on one system so that the laboratories can consolidate their workload to one platform.“

A spokeswoman for Abbott said that which system a hospital buys depends on the size of the hospital and its laboratory volume. A smaller hospital with less volume might have the AxSYM system, while a larger hospital could benefit from an integrated system such as the Architect ci8200.

Abbott also reported late last month that it is introducing 10 clinical chemistry tests for specific proteins, also for use on the Architect c8000 and Architect ci8200 immunochemistry systems.

The 10 protein tests include Apolipoprotein A1, Apolipo-protein B, Complement C3, Complement C4, Haptoglobin, Immunoglobin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin.

Specific protein tests are used to gain information about particular diseases or conditions, and the ones just added represent “a potpourri of different markers and different utilities,“ said Mayra Vazquez, marketing manager of reagent initiatives.

The new tests, which also are available for use on Abbott's Aeroset system, are typically run only at mid-to-large hospitals, she said.

Vazquez also told MDD that the immunoglobulins that are “used for the general treatment of immunological disease“ are the highest-volume tests.

Abbott offers 12 protein tests in the U.S. and about 25 in international markets. However, Vazquez said that the company plans to offer all of its protein tests within the U.S. by year's end, “depending on requirements and how things go.“

Abbott also reported in late January that it was introducing an improved progesterone test for the Architect system. Progesterone is a female hormone that works in conjunction with other hormones to help prepare a woman's body for pregnancy.