A Medical Device Daily

Cambridge Heart (Bedford, Massachusetts) said last week that its Canadian REFINE (for Risk Estimation Following Infarction-Noninvasive Evaluation) study has completed its enrollment of 350 patients.

The company's Microvolt T-Wave Alternans Test measures subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. Cambridge Heart said these tiny heartbeat variations, which are measured at one millionth of a volt, are detected in any clinical setting where titration of the heart rate is possible.

Clinical research has shown that patients with symptoms of or at risk of life-threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events, including sudden death, while those who test negative are at minimal risk.

The study enrolled patients who had experienced a recent myocardial infarction or heart attack and who also had impaired pumping efficiency of the heart as determined by an ejection fraction of 50% or less.

Derek Exner, MD, associate professor of medicine at the University of Calgary's (Calgary, Alberta) Libin Cardio- vascular Institute of Alberta, is principal investigator for the trial.

All patients were being treated with optimal medical therapy. In addition to Microvolt T-Wave Alternans (MTWA), the trial evaluates various non-invasive parameters, including signal-averaged ECG, baroreceptor sensitivity and several Holter measures such as heart rate variability.

In the trial, each parameter will be evaluated singly and in combination.

A primary hypothesis of the trial is that MTWA assessment as a single test will have the greatest prognostic utility in predicting the endpoints of sudden cardiac death, resuscitated ventricular fibrillation or sustained ventricular tachycardia.

Exner said the REFINE trial “evaluates the usefulness of MTWA and the other tests in patients with varying degrees of heart muscle weakness after a heart attack. It will also define the optimal time for patients to undergo assessment of MTWA and the other noninvasive tests after a heart attack.“

Cambridge Heart CEO David Chazanovitz said, “While we have numerous studies on MTWA in the ischemic population, this is the first study to look at ejection fraction as high as 50% and also accomplished serial testing. The evaluation of individuals up to a 50% ejection fraction will no doubt identify individuals whose level of risk would not otherwise be fully appreciated.“

Patient follow-up in the study will continue through 2005, with results expected to be available in the first half of 2006.

Collaboration on genetic markers

Sequenom (San Diego) and Iceland Genomics (Reykjavik, Iceland) reported entering into a research collaboration to analyze Sequenom's proprietary panels of genetic markers associated with breast and prostate cancer in Icelandic patient samples.

The U.S. firm said the results of this collaboration could provide further validation of its genetic markers predisposing for breast and prostate cancer, and improve the understanding of the role of the markers in disease onset, progression and therapeutic response.

Sequenom's genetic markers were discovered through a series of genome-wide association studies and subsequently replicated in multiple independent clinical collections. Among the markers to be studied in the Icelandic population are single-nucleotide polymorphisms (SNPs) from the ICAM and NuMA gene regions.

Iceland Genomics and Sequenom will jointly analyze the resulting data to determine to what extent the disease predisposition markers are associated with specific clinical endpoints.

“The collaboration between our two companies may lead to important breast and prostate cancer diagnostic and prognostic applications in the field of molecular medicine,“ said Steve Zaniboni, acting CEO of Sequenom. “The study should provide insight to what extent genetic markers that predispose an individual to a higher disease risk affect disease progression and therapeutic outcome.“

Zaniboni said the company has identified and validated more than 60 high-confidence candidate gene regions in 11 major disease areas. “This collaboration is part of a program to establish the diagnostic value of [our] disease gene portfolio beyond disease predisposition,“ he said.

Dana Hosseini, CEO of privately held Iceland Genomics, said, “Iceland is a very exciting and rewarding place for performing genetic analysis of complex diseases such as cancer. Comprehensive clinical data combined with the participation and goodwill of Icelanders and the clinical community provides an unparalleled basis for a successful research effort.“

Iceland Genomics will utilize its large collections of breast and prostate cancer patient samples and clinical databases to test and validate the markers. The results of the collaboration are expected to increase the utility and value of Iceland Genomics' cancer genomic database.

Sequenom has commercialization rights for products developed as a result of the collaboration, with Iceland Genomics to receive royalties from sales of any such products.

Sequenom's MassARRAY system is a high-performance DNA analysis platform that precisely measures the amount of genetic target material and variations therein.

VScan test kits on sale in Russia

Medical Services International (Edmonton, Alberta) said it has begun shipping its VScan HIV test kits into Russia. It said that in addition to the HIV kits, there has been an expressed interest and demand for the VScan TB test kit.

The company said marketing studies for the region show that it is reasonable to expect that there will be a demand for 2 million to 3 million VScan test kits a year. It said the distributors that have been signed for Eastern Europe have indicated that the demand for test kits for HIV and TB is increasing substantially and the fact that VScan is easy to use, very accurate using whole blood and requires no refrigeration will create a significant demand for the kits.

The VScan rapid test kit is a single-use test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, Dengue fever, West Nile virus and syphilis.