A Diagnostics & Imaging Week

Genesis Bioventures (GBI; New York) said it has granted an exclusive license to Bio Business Development Co. (BBDC) to commercialize the Rapid Prion Detection Assays in 18 Pacific Rim countries. The licensed technology has been developed by Prion Developmental Laboratories (PDL), a portfolio company of GBI.

GBI has the exclusive, worldwide sales, marketing and distribution rights to commercialize the recently patented Rapid Prion Detection Assays, including rapid tests for bovine spongiform encephalopathy (BSE, or "mad cow" disease) in cattle and scrapie in sheep. With the agreement, BBDC, a Canadian business development company, becomes GBI's marketing, sales and distribution partner in the Pacific Rim to launch sales of the assays.

Our commercialization strategy is focused on global partnering, which we believe will get us to market quickly at substantially lower costs," said Douglas Lane, CEO and president of Genesis Bioventures. "Our initial target markets for PDL's BSE Rapid Assay are in the Pacific Rim. BBDC has extensive contacts in Australia, New Zealand, China, and Japan, which has stringent procedures that require all animals used for food production to be tested for BSE."

He added: "Our patented Rapid Prion-Detection Assay is designed to test for prion diseases, such as mad cow disease, directly at the point-of-kill rather than in a laboratory. The assay is an easy-to-use rapid strip test that can be administered by trained individuals at slaughterhouses with visual results produced in less than an hour."

PDL recently achieved 100% sensitivity and 100% specificity in a trial on confirmed positive and negative samples at the Veterinary Laboratory Agency (Weybridge, UK).

The company produces tests for transmissible spongiform encephalopathies such as BSE in cattle, scrapie in sheep and goats, and chronic wasting disease in deer. Formed in 2001, PDL has developed a number of rapid tests that are manufactured on-site.

AlzheimAlert distributor in Korea

Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) said it has entered into a distribution agreement with Kyung Min Meditech (Seoul, South Korea) for the marketing and sale of the company's AlzheimAlert kit in South Korea.

AlzheimAlert provides physicians with a tool for the diagnosis of Alzheimer's disease (AD) by measuring levels of a biomarker for the disease in patient urine samples.

Brian Doyle, Nymox's senior manager for worldwide sales and marketing, said, "Korea represents an important new market for this innovative product. With this agreement, Nymox has a presence in Asia to complement our existing distribution agreements for AlzheimAlert in Europe."

The AlzheimAlert test measures the level of a brain protein called neural thread protein found in higher amounts in the urine of patients suffering from Alzheimer's disease. Nymox said the test is the only one of its kind and aids in the often-difficult task of diagnosing AD in a patient.

There are an estimated 4.5 million people with Alzheimer's disease in the U.S. alone, a number is projected to increase almost three-fold to 13.2 million by 2050. Worldwide estimates of the current number of people with the disease range from 15 million to 20 million.

Cardiac marker market on growth curve

The market for cardiac markers used in primary care is experiencing a tremendous rate of growth across Europe due to their precise diagnostic properties. With rapid turn-around times, these cardiac markers are seen enabling cost reductions and improved patient outcomes.

International consulting firm Frost & Sullivan says that over the next three to four years, cardiac markers will be implemented more effectively in primary care to support decreased bed occupancy, hospital costs and physician time.

Frost & Sullivan said that the European primary care cardiac diagnostics market had revenues of $50.3 million in 2005 and estimates this to reach $149.4 million in 2012.

"Cardiac point-of-care testing [POCT] offers many benefits for primary care, particularly in improving turnaround results and in allowing earlier and more appropriate treatment," said Dr. Fiona Rahman, Frost & Sullivan team leader of clinical diagnostics.

She added: "POCT can better satisfy customer needs with the introduction of new cardiac markers; in addition to boosting patient confidence with on-the-spot tests that improve disease diagnosis and monitoring, these diagnostics also enable the implementation of programs designed to prevent the onset of diseases."

Cardiologists have developed the market by switching from conventional methods of heart disease diagnosis to these markers. The use of cardiac diagnostic tests in primary care is poised to grow due to the introduction of point-of-care technologies.

"These cardiac markers will give more valuable indications during emergencies towards determining appropriate treatments and the level of risk of a heart attack," said Rahman. "The rapid turnaround times of cardiac markers will reduce costs and improve the treatment of patients admitted with chest pain."

She said that although the science behind cardiac assessment is growing, the cardiology community still requires further education and training on the advantages of these risk markers. Rahman said medical communities in the UK and France in particular are hesitant to adopt new methods of diagnosing, treating and managing patients without adequate corroboration that they will make significantly enhanced contributions to patient well-being and cost savings.

"Physicians are sceptical about adopting novel markers and continue to rely on tried and tested methods of diagnosis, which are cheaper and do not require validation and scientific support," she said. "These end users are reluctant to experiment with expensive markers, which are essential to complement more traditional diagnostic methods."

In its report, "European Utilization of Cardiac Markers in Primary Care," Frost & Sullivan said the challenge for manufacturers will be to promote cost-effective cardiac diagnostics markers as well as to encourage end users to trial and adopt risk tests as routine diagnosis.

Ultimately, the report said, increasing awareness about the benefits of using cardiac markers in primary care will benefit both healthcare providers and patients. Informed patients who understand the concept of cardiac markers are more likely to request the most current and novel markers available.

Bracco/VisualSonics development accord

VisualSonics (Toronto), a developer of high-resolution, ultrasound-based, in vivo micro-imaging systems, and the Bracco Group, a maker of ultrasound-based contrast agents, have signed an agreement for the joint development and manufacture of MicroMarker contrast agents optimized for preclinical molecular imaging on VisualSonics' Vevo 770 micro-ultrasound platform.

Bracco will develop and manufacture a complete line of contrast agent kits for VisualSonics' rapidly growing customer base using the Vevo 770 micro-ultrasound platform, specifically designed for the preclinical research market. Bracco will manufacture the agents based on its technology at Bracco Research (Geneva, Switzerland). The two companies will collaborate to develop a complete line of kits and protocols for a variety of biomarkers and research applications including cancer, cardio and vascular applications.

"With the addition of contrast-enhanced molecular imaging capabilities to its micro-ultrasound technology, VisualSonics/Bracco offer the only platform with high spatial and temporal resolution that simultaneously provides anatomical, functional and molecular data," said Dr. Michel Schneider, director of Bracco Research.

VisualSonics CEO Tom Little said, "VisualSonics and Bracco are in an ideal position to penetrate the $500 million incremental annual market potential in preclinical contrast agent revenues. By partnering with Bracco, we are able to leverage their world-class expertise in manufacturing contrast agent kits and quickly provide a variety of application-specific kits and protocols optimized for our customers' specific research and drug discovery and development needs."

The companies said micro-ultrasound is the fastest-growing preclinical imaging modality, facilitating research in areas such as cancer, stem cell research and developmental biology.

U.S. lab firm adds European network

LabConnect (Seattle) said that Synevo-Medicover Laboratory Services has signed a definitive agreement to join the LabConnect network, resulting in LabConnect becoming the first U.S.-based central laboratory with a presence in Central and Eastern Europe.

Synevo-Medicover Laboratory Network is Central and Eastern Europe's largest laboratory services provider. It has 23 facilities and more than 650 employees.

LabConnect and Synevo will jointly provide centralized laboratory services for the European continent from laboratories based in Poland and Romania.

"We're currently managing several global projects with Synevo and we're betting that our clients will increasingly seek out Central and Eastern European investigator sites. Sites in the region are well-known for their recruitment success combined with high-quality and cost-effective research," said LabConnect President and CEO Eric Hayashi.

Synevo is the laboratory diagnostics division of Medicover (Luxembourg), the leading private healthcare provider in Central and Eastern Europe.