A Medical Device Daily
Abbott Diagnostics (Abbott Park, Illinois) said it has signed an exclusive agreement with Cincinnati Children'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 report-ed 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 he 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.
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.
The World Health Organization (Geneva, Switzerland) recommends that CD4 be measured in all HIV/AIDS patients every three months.
Dr. Petra Krauledat, PointCare Technology's president and CEO, said of the agreement, “Working together, we plan to make immune hematological testing easier and more broadly usable.”
Krauledat said an invention by Dr. Peter Hansen, PointCare's chief scientific officer, brought CD4 testing out of the research laboratory and into the clinical setting, 25 years ago by eliminating “complex and cumbersome” sample preparation techniques.
Richard DePiano, Escalon chairman and CEO, said, “This collaboration will extend our product portfolio and, by offering a fully integrated, low-cost instrument that will be unique in its ability to perform both a full hematology test and a CD4 test, will provide us the opportunity to develop new markets for our hematology business.”