A Medical Device Daily

Inverness Medical Innovations (Waltham, Massachusetts) said that its Wampole Laboratories (Princeton, New Jersey) subsidiary has signed an agreement with Roche Diagnostics (Indianapolis) to collaborate on the first fully automated diagnostic test for ischemia-modified albumin (IMA).

The current plan is for the albumin cobalt binding (ACB) test for detection of IMA to be available on the Roche Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems, and Inverness is currently preparing to submit a premarket notification with the FDA for clearance.

IMA is a key marker of cardiac ischemia used in the assessment of patients with chest pain suggestive of a heart attack.

The agreement states that Wampole will sell and distribute the IMA test for Roche Diagnostics analyzers, and that they will be working with Roche Diagnostics on a co-marketing agreement for the IMA test.

The IMA assay also is available on other analyzers from Roche Diagnostics, including the Roche/Hitachi Modular Analytics Plus, the Roche/Hitachi 917, the Roche/Hitachi 911, and the Roche Cobas Mira Plus analyzers.

IMA is a serum biomarker that, when used in conjunction with echocardiogram (ECG) and cardiac troponin tests, assists in the early evaluation of acute coronary syndromes (ACS) in patients presenting to hospital emergency departments with chest pain.

DaVita (El Segundo, California) said that the Centers for Medicare & Medicaid Services (CMS; Baltimore) has selected RMS Disease Management, a wholly owned subsidiary of DaVita, to operate a three-year demonstration project to help Medicare beneficiaries with chronic kidney disease improve their quality of life while reducing their medical expenses and Medicare program costs.

“This demonstration project will focus on Medicare beneficiaries who have the most to gain from our healthcare system but who too often don’t get the best possible prevention-oriented care,” said CMS Administrator Mark McClellan, MD, PhD. “They often see numerous doctors without the continuity of care and support needed to enable the health professionals to work together effectively, and they often are unable to take advantage of evidence-based steps to prevent the complications of their diseases.”

RMS Disease Management is one of six organizations selected by CMS for the Care Management for High Cost Beneficiaries demonstration. The demonstration will test the ability of direct-care provider models to coordinate care for high-cost/high-risk beneficiaries by providing such beneficiaries with support to manage their conditions and enjoy a better quality of life.

MedicAlert (Turlock, California) has entered into a strategic alliance with Honeywell HomMed (Brookfield, Wisconsin), which focuses on home healthcare and remote vital signs tracking and assessment. MedicAlert will soon offer the Health Enhancement System to its members nationwide.

MedicAlert Health Enhancement System is designed to help patients keep track of their health. Using voice and text prompts, the Health Enhancement System guides patients through a simple three minute procedure to collect information such as weight, blood pressure and answers to disease-specific questions.

After each session, the information is automatically and securely transmitted to MedicAlert and becomes part of the patient’s personal electronic health record stored at the MedicAlert repository.

The information can be made available to the patient, their physician and any designated family members. If the information collected indicates a need for intervention of if the patient fails or forgets to use the system when prompted, they are contacted by MedicAlert to determine appropriate course of action.

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