A Diagnostics & Imaging Week

Abbott Diagnostics (Abbott Park, Illinois) said it has signed an exclusive agreement with Cincinnati Child-ren's Hospital to develop a urine-based diagnostic assay to detect kidney injury and disease using the protein neutrophil gelatinase-associated lipocalin (NGAL).

NGAL is a biomarker reported to be valuable in diagnosing acute kidney failure in a matter of hours, compared to tests that may take up to several days.

"We are excited to begin our work in developing a test that may help clinicians address kidney failure much earlier and with greater precision," said William Brown, PhD, vice president, diagnostic assays and systems development at Abbott. "When available, this will be an important addition to our menus."

Acute kidney failure is present in 5% of all hospital admissions and in up to 30% of patients in intensive care units (ICUs). When advanced kidney failure is observed in the ICU, mortality rates of 40% to 80% have been reported. Studies show that the cost of treating advanced kidney failure in the ICU is $50,000 per patient.

"Early identification of acute kidney failure is the key to helping physicians manage and treat the condition more effectively," said Prasad Devarajan, MD, director of the division of nephrology and hypertension at Cincinnati Children's.

A study in the April 2005 edition of The Lancet reported that concentrations of NGAL were "strikingly raised" in the urine and serum of children with acute kidney failure after undergoing cardiopulmonary bypass surgery. Another study, in the May 2006 edition of the American Journal of Transplantation, reported that NGAL may be used to predict kidney failure in patients following kidney transplantation.

"The work carried out by Dr. Devarajan represents a pioneering effort to move medicine into a more individualized and prospective mode," said Tom Boat, MD, chairman of pediatrics and director of the Cincinnati Children's Research Foundation.

Abbott said NGAL is one of several innovative biomarkers that its scientists are working with to develop assays for the company's analyzers. The company is developing automated assays to help physicians diagnose patients with pre-eclampsia and small-cell lung cancer.

Brown said that Abbott expects to introduce such assays, among others, over the next several years.

Fonterra (Singapore), a global dairy business and expert in nutritional dairy products, and GE Healthcare's (Waukesha, Wisconsin) Lunar (Madison, Wisconsin) business, termed the industry leader in bone assessment technologies, reported a partnership to tackle the growing global health problem of osteoporosis using Fonterra's Anlene bone health products and GE Healthcare's bone mineral density technology.

Representatives from Fonterra and GE Healthcare signed the three-year agreement in Singapore. Financial terms of the partnership were not announced.

The partnership's first initiative is the Anlene Bone Health Check, a consumer awareness campaign to provide free ultrasound bone health screenings to an estimated 3 million people across nine Asian countries over the next two years. The next phase is likely to extend to Australia and New Zealand.

Fonterra Brands Managing Director Sanjay Khosla said the partnership is about bringing together the innovation and expertise of two leading companies to reach a new level of understanding about osteoporosis and bone health.

Jennie Hanson, president of the Lunar business, said, "Osteoporosis is a global healthcare concern. Our bone mineral density technologies play an important role in the fight against the disease. By understanding and addressing this manageable disease before symptoms appear, doctors and patients can be equipped with the information they need to act earlier, with better clarity and more precise tailored treatments."

She termed Fonterra "a progressive and innovative company" that she said "shares our vision of promoting 'early health' on a large scale in a large region." Saying "both GE Healthcare and Fonterra are known to bring innovative products to their respective customers," Hanson said, "We will work together to leverage these strengths to provide an effective bone health solution."

Khosla said the program would capture a comprehensive bank of data on bone health that will be shared with other majoragencies addressing osteoporosis and bone health problems, including the International Osteoporosis Foundation (IOF).

The IOF estimates that by 2050 the worldwide cost of osteoporosis will increase to $131.5 billion. The current direct cost of treating osteoporosis fractures in the workplace in the U.S., Canada and Europe is about $48 billion. It said that more than 50% of the world's hip fractures are likely to occur in Asia by 2050, resulting in increased health costs for governments, health authorities, families and individuals.

"This partnership will highlight the problem of poor bone health while people still have time to do something about it," Khosla said.

He said the Anlene Bone Health Check has the potential to generate extensive public awareness about the importance of bone health by taking the bone health message into the streets, shopping malls and work places. "We are offering the service first in Asia where osteoporosis is a major health issue," Khosla said. "The bone health screenings will raise awareness and also provide an opportunity to give people practical steps they can take towards improving their bone health."

Fonterra is a multi-national dairy company and one of the world's leading dairy ingredients and consumer businesses. It said it is the world's largest exporter of dairy products, with annual revenues of around $7.8 billion. Its consumer dairy business operates in 40 countries and its products are among the best known dairy brands in the world.

Its Anlene unit has a long history in bone health and has relationships with leading bone health specialists and researchers. Over the last 10 years, it has funded and been involved with 13 clinical trials relating to bone health.

In other agreement news:

• Asterand (Detroit), a human tissue provider, said it has signed a partnership with Rubicon Genomics (Ann Arbor, Michigan) to discover novel biomarkers for cancer diagnosis. Asterand will supply tissue and biofluid samples from its biorepository and its network of clinical collaborators. Rubicon will perform studies with the samples using its MethylPlex technology to discover more sensitive and specific methylated DNA markers for cancer diagnosis and prognosis.

DNA methylation is a mechanism by which cells become cancerous and grow out of control. Studies have shown that methylated DNA sequences can be detected in the blood of cancer patients, so these modified DNAs can be sensitive markers for the presence of cancer.

"The current tests to detect cancer are often not sufficiently sensitive to detect cancer at an early stage," said Asterand Chief Scientific Officer Dr. James Eliason.

"Collaborating with Asterand will allow us to accelerate development of our diagnostic products," said Dr. John Langmore, Rubicon vice president for commercial development.

• Escalon Medical (Wayne, Pennsylvania) said that its Drew Scientific subsidiary has signed a manufacturing, worldwide distribution and co-marketing agreement with PointCare Technologies (Boston), a diagnostics company providing CD4 blood cell testing systems to monitor immune system functions and progression of HIV/AIDS.

Drew will expand its Excell 22 five-part differential hematology platform to perform PointCare's CD4 test, and PointCare will modify its chemical reagents to run on the Excell 22.

The diagnostic platform is expected to be launched in the first half of 2007, assuming 510(K) FDA clearance. Both companies will have the rights to market the instrument and reagents.

The companies said that this test platform is expected to be the first system to provide the combination of hematology and CD4 testing on an affordable, fully automated instrument and "much easier" to use than existing CD4 techniques, so it can be used in HIV/AIDS clinics worldwide even if highly trained laboratory specialists are not available.

• NIR Diagnostics (Campbellville, Ontario), a developer of hand-held spectroscopy-based instruments, reported a license and royalty agreement with Shaklee (Pleasanton, California) to develop, manufacture and distribute NIR's in vivo light-based technology and the HemoNIR CO-oximeter device. The agreement, still requiring various approvals, includes applications of NIR's light-based technology for the medical device and laboratory device and food supplement markets.

Shaklee will market NIR Diagnostics' multi-analyte light-based device to its distributors worldwide, with Shaklee to make an upfront payment of $2 million upon satisfaction of various conditions and a $1 million milestone payment upon completion of a food supplement device within one year.

NIR also will receive what it termed "an industry-standard royalty" from the sales of a food supplement device. If the prototype device is not completed within the one year, NIR will issue to Shaklee a purchase warrant for 13.3 million warrants exercisable into common shares of NIR.

NIR also has provided Shaklee with an exclusive license in certain countries to the HemoNIR CO-oximeter device, with NIR to receive a maximum payment of $1 million – $250,000 upon finalizing the rights in three Asian countries and additional options of up to $750,000 for three other regions. Shaklee and NIR will share revenues 50/50 from the sale of in vivo devices for medical applications from all sources.

"The basis of this agreement is the trend toward healthier dietary and lifestyle choices and the potential impact of a low cost, non-invasive consumer device to encourage those choices. Historically diagnostic devices, whether point-of-care or laboratory based, were considered to have only disease state application," said Duncan MacIntyre, president/CEO and executive vice chairman of NIR.

The agreement is expected to become effective about July 31.

NIR develops optical, electronic and algorithm-related products in the field of in vitro and in vivo blood analysis.

• Medicsight (London), parent company to both Medicsight plc, a developer of computer-aided detection (CAD) technologies and software, and Medicexchange.com, an online sales channel for diagnostic, treatment and surgery planning solutions, reported that Medicexchange.com has signed an agreement with AuntMinnie.com, an online resource for radiologists, for the development of the Software Center, a centralized directory of downloadable medical imaging software solutions.

AuntMinnie.com will create the Software Center as an exclusive section within its "Communities" area that will house descriptions of and provide links to the latest software applications for demo and download. The section will include links to Medicexchange.com's downloadable imaging solutions and enable other imaging software vendors to list their applications.

The center is expected to launch in August.

AuntMinnie.com said it would provide its users with technical requirements and downloading instructions for each of the software offerings, plus descriptions and previews of applications.

Initially, Medicexchange.com's software listings through AuntMinnie.com will focus on thoracic, cardiac, orthopedic, abdominal and women's imaging. David Mason, executive vice president, corporate development for Medicsight, called AuntMinnie.com a "premier online resource" for radiologists. "AuntMinnie.com's established relationships with and access to radiologists will be invaluable as we introduce Medicexchange.com."

Ashok Shah, general manager of AuntMinnie.com, said, "We believe that better access to these software tools will not only help radiologists in their practice, but improve the level of care provided to patients as well."

Medicsight plc's software solutions help clinicians identify, measure and analyze suspicious pathology, such as colorectal polyps and lung lesions.

The company's CAD products include ColonCAD API, the first CAD technology available for CT colonography, and LungCAD API.

• BioSurplus (San Diego), a provider of pre-owned laboratory instruments and equipment management services, has been invited to join the Biocom Purchasing Group, giving Biocom members discounted access to the company's goods and services.

The purchasing group is designed to help Biocom members achieve the same purchasing economies of scale of large institutions by combining the volume of its member companies in a purchasing consortium that negotiates for set discounts with suppliers.

BioSurplus carries an extensive inventory of laboratory and process equipment, including manufacturer demos, refurbished instruments and other pre-owned items. It maintains a large warehouse facility and showroom.

"Whether a company is in the midst of a corporate merger, acquisition, upsizing, downsizing or liquidation, our turnkey services eliminate equipment-related head-aches while maximizing equipment value, control and accountability," says CEO Preston "Cinco" Plumb.

BioSurplus's services include inventorying, managing, valuing, redeploying, acquiring and reselling equipment. It says it is the leading provider of pre-owned laboratory instrument resale and equipment management services for biotechnology companies, colleges and universities.

Biocom is a life science industry association representing nearly 500 member companies.