A Diagnostics & Imaging Week

Adlyfe (Rockville, Maryland), a privately held firm focused on early diagnostics for animal and human brain diseases, reported being awarded a $650,000, two-year grant from the UK Department of Environment, Food and Rural Affairs (DEFRA) for continued development of a sensitive early blood test for animal prion diseases.

Misfolded prion proteins are correlated to sheep scrapie disease, “mad cow” disease in cattle, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease in humans.

DEFRA is the UK agency whose mission is to fund emerging technologies that can thwart the spread of animal and human disease. The agency has a long history of supporting R&D in chronic diseases that impact animal and human health, along with the safety of the food supply and the environment.

The grant award is focused on addressing issues in the development of the Adlyfe test that will enable early blood detection and live animal screening for disease in both sheep and cattle.

Adlyfe will work in collaboration with the Moredun Institute (Penicuik, Scotland), a leading research institute in the field of animal disease.

“This is an important step for our company to broaden our international base of support and collaboration for development of our test for prion diseases,” said Alan Rudolph, CEO and president.

He added: “These diseases are global, with significant impact on animal and human health. We are pleased that DEFRA recognizes the value of our technology and support[s] continued development of our sensitive blood test for these diseases.”

The danger for humans from cows with mad cow disease is that people who eat the meat of an infected cow can develop the human form of the brain-wasting disease known as Creutzfeldt-Jacob disease. Although there have been confirmed cases of people in the UK contracting the disease through blood transfusions, there still is no way to screen blood or test cattle without first killing them and examining their brain tissue. Mad cow is a neurological disease.

Aside from the UK grant, Adlyfe previously has received about $6 million in federal funding from the National Institutes of Health (NIH; Bethesda, Maryland) and the Defense Advanced Research Projects Agency (DARPA; Arlington, Virginia), not all of it devoted to prion diseases.

“This originated with DARPA and NIH, and it actually had its origins in DARPA’s interest in threats to biosecurity, because in the cattle case, it’s only a few animals [that would have to be affected before one could see] large consequences to agro-economics, such as the closing of export markets,” Rudolph said. “So, it was in that spirit in which DARPA’s interest in the technology was motivated toward providing security against emerging threats.”

The test that is being developed to provide earlier diagnosis of mad cow disease was developed by Cindy Orser, vice president of research and development at Adlyfe.

In addition to the test for mad cow disease, Adlyfe is developing a blood-screening test for humans with a test called BSE-pronucleon. The company said the test provides results in 30 minutes, and because of its sensitivity, it also will have application to bovine byproducts such as gelatin, serum albumin and fetal calf serum. Those are products with human applications such as pharmaceuticals, cell-based therapeutics and cosmetics, meaning that they are regulated by the FDA.

CE mark for OsteoGram system

CompuMed (Los Angeles), developer of computer-aided diagnostic (CAD) solutions for the healthcare industry, said it has received approval to use CE marking to market its OsteoGram system throughout the European Union, following an audit conducted by TUV Rhineland North America.

OsteoGram is a software-based system for screening, diagnosing and monitoring osteoporosis. It provides what the company characterizes as “an accurate, low-cost alternative to DXA bone mineral density (BMD) screening.” CompuMed said that as the global population ages, the costs associated with osteoporosis-related disease are predicted to rise dramatically.

“We believe the OsteoGram is an ideal solution in countries under financial pressure to lower healthcare costs,” said CEO Jerry McLaughlin. “With the CE mark .... CompuMed takes a significant step forward in providing European customers with an exciting new solution for routine osteoporosis testing,” he said. “We can now enter EU markets where demand for low-cost osteoporosis testing methods is growing dramatically, as countries with national health plans are being forced to evaluate inevitable limits on the acquisition of high-cost DXA equipment.”

In addition to CE mark approval, CompuMed also earned certification to ISO 13485, the international standard developed to ensure that companies provide medical devices that meet customer and regulatory requirements. ISO certification verifies that CompuMed meets strict requirements for quality management systems applicable to medical devices and related services.

The company said the ISO certification increases the potential for licensing partnerships with other ISO-certified manufacturers of digital radiographic platforms.

The OsteoGram can be utilized in conjunction with rapidly proliferating digital (i.e., filmless) X-ray equipment, as well as existing film-based machines. CompuMed said its benefits in terms of cost and efficiency facilitate wider osteoporosis screening and treatment of at-risk patients.

The company said the OsteoGram system is “far less costly and cumbersome to use than conventional BMD testing systems, which require dedicated and expensive equipment, computers, office space and staff.”

The UK recently launched a program to utilize peripheral devices, such as the OsteoGram system, for widespread osteoporosis screening. Osteoporosis affects more than 200 million people worldwide, the company said, with the International Osteoporosis Foundation estimating that in Europe alone, 611,000 women and 179,000 men will suffer a hip fracture each year.

The annual direct cost of all osteoporotic fractures in Europe is EUR 25 billion. Costs are expected to increase to EUR 76.7 billion by 2050, based on expected changes in demographics and increasing life expectancies.

In addition to the OsteoGram, CompuMed manufactures the CardioGram system, which remotely interprets electrocardiograms and is used by private practice, government and corporate healthcare providers nationwide.

Focus in license accord on new SARS virus test

Focus Diagnostics (Herndon, Virginia) reported a license agreement with Primagen Holding (Amsterdam, the Netherlands) to develop polymerase chain reaction (PCR) detection for human coronavirus NL63, a newly identified virus related to sudden acute respiratory syndrome (SARS) and other coronaviruses.

The new coronavirus causes severe respiratory disease in children under 5 and is associated with respiratory disease in adults and the elderly.

Focus Diagnostics said the agreement would allow its infectious disease reference laboratory in Cypress, California, to be the first U.S laboratory to bring to market a test for the new infectious agent.

CEO Charles Harwood Jr. said, “Our charter is to develop new diagnostic tests that help physicians make a diagnosis that leads to better patient management.”

The company was the first laboratory in the U.S. to offer PCR testing for SARS coronavirus in 2002 and for human metapneumovirus (hMPV) in 2003, both newly discovered respiratory viruses that previously had no diagnostic test available for physicians.

Focus Diagnostics said its reference laboratory expects to make an announcement later this year regarding the availability of a coronavirus CoV-NL63 assay.

The company said Dr. Lia van der Hoek and her colleagues at the Academic Medical Center (Amsterdam) first described the newly identified coronavirus, related to SARS and other viruses that cause common colds and animal diseases, in 2004. The virus is the subject of a patent application filed by its discoverers, and rights to the patent have been assigned to Primagen Holding.

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