A Diagnostics & Imaging Week

The U.S. Army has signed a Collaborative Research and Development Agreement with Vicor Technologies (Boca Raton, Florida) to investigate technology that could assess the severity of injury and probability of survival, of critically injured combat casualties and critically ill civilian patients.

Vicor’s PD2i Cardiac Analyzer risk stratifies patients who are at high or low risk of suffering a fatal arrhythmic event or sudden cardiac death (SCD) within a six-month time frame. But the technology can be adapted to analyze any biological stream of data.

“Our initial application is focused on stratifying patients at risk for sudden cardiac death,” Vicor president/CEO David Fater told Diagnostics & Imaging Week. “Our technology is being looked at as another vital sign that can be collected relatively easily because it’s based on a digital EKG recording. Our algorithm and software can analyze those heartbeats and can identify those patients who are in need of life-saving intervention.”

The army and Vicor will test the PD2i algorithm in several diverse cohorts of animal data as well as in human trauma, ICU patients and combat casualties. It is expected that the effort will lead to lead to development of new comprehensive decision support tools.

Vicor’s PD2i Cardiac Analyzer is based on an algorithm that the company intends to guard close to home.

“If FDA-approved, we intend to operate like a Quest Laboratory model,” Fater said. “Physicians send us a digital EKG file with 1,000 heartbeats. It gets processed through our software and a report comes back that says the patient is positive or negative. Right now, we’re not letting go of the software in the commercial applications because we don’t want any software piracy.”

The military application, however, may eventually include hardware loaded with the software.

Vicor’s VITAL Trial (a prospective, multicenter study of the ability of the PD2i Cardiac Analyzer to predict risk of VentrIcular TachyArrhythmic events such as sudden cardiac death, ventricuLar fibrillation or ventricular tachycardia in high-risk patients) was initiated in August 2006 and is being conducted by Harvard Clinical Research Institute (Boston).

The FDA, in pre-investigational device exemption meetings, has agreed to final PD2i protocol and study design for the pivotal VITAL study.

The Vicor product’s closest competitor is Cambridge Heart’s (Bedford, Massachusetts) HearTwave II Microvolt T-Wave Alternans test, which measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person’s electrocardiogram.

Fater said a primary difference between the two technologies is that Vicor will offer it as a service ($100 per patient analysis), rather than as a standalone product that physicians must purchase and keep in their offices.

He added that the technology could eventually be adapted to assess a vast array of conditions and diseases from burn victims to Alzheimer’s disease risk.

In other agreement news:

• Luminex (Austin, Texas) said it has renewed and expanded Invitrogen’s (Carlsbad, California) license and supply agreement for Luminex’s multiplexed analyte detection technology and systems. The new agreement extends the lifetime of the license and provides Invitrogen with access to Luminex’s next-generation multiplex detection platforms.

xMAP Technology and Luminex instrument platforms use proprietary microspheres — micron-sized beads —encoded with combinations of spectrally distinct fluorescent dyes to rapidly and reproducibly determine the relative concentrations of many different proteins or peptides at the same time in the same sample.

Invitrogen offers more than 200 assays based on xMAP Technology. Invitrogen also has a large number of new multiplexed assays in its product development pipeline to expand the number of targets accessible to scientists. The company will offer custom assay development services using the next-generation platform that complement its existing service of rapid, affordable multiplex assay development on the original Luminex platform.

“We are pleased with this new agreement and committed to our relationship with Luminex,” said Kip Miller, Invitrogen’s senior VP, BioDiscovery. “It is another step in our strategy of building on our position as the leading cell biology reagent provider to offer our customers integrated systems and solutions.”

Luminex develops biological testing technologies with applications throughout the diagnostic and life sciences industries.

• Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology for the ablation of cancer and other chronic health conditions, reported an agreement with Medline Industries (Mundelein, Illinois) for the domestic distribution of the SonicOne Ultrasonic Wound Debridement System has expired.

In a limited-release test market, Misonix and Medline have been working together to determine the best distribution model for the product. Both companies said the best opportunity for market success would be sales of the product by Misonix through a proprietary distribution network. Medline will continue to close pending SonicOne sales opportunities through March of this year.