Biosite announced this week a collaboration with Hopitaux Universitaires de Geneve to identify biomarkers linked to acute kidney injury and acute renal failure.
The deal follows an earlier biomarker-identification agreement between San Diego-based Biosite and the Cincinnati Children’s Hospital Medical Center and Columbia University in the area of kidney disease.
Under the terms of the agreement with HUG, Biosite will use its technologies, including the development of high-capacity antibodies, to validate biomarkers that have been discovered by researchers at HUG.
According to a press release, the research groups of Solange Moll and Denis Hochstrasser have discovered more than 10 proteins specific to kidney function that have the potential to yield biomarkers for renal diseases.
There “aren’t that many people who are working on renal injury with respect to proteomic approaches.”
HUG used mass spec analysis to find its biomarkers, which has limited “utility in terms of the number of samples you can analyze,” according to Gunars Valkirs, senior vice president of discovery at Biosite’s research institute. Biosite’s role, therefore, is to select targets and generate the immunoassays to validate their utility.
Ultimately, Biosite’s goal is to develop tests that can confirm that kidney injuries have occurred and that, in some cases, can predict who is likely to progress to renal failure if the patient is given certain procedures such as angiograms.
“As physicians, we perceive the acute need for such a diagnostic, and we are hopeful that our collaboration with Biosite will eventually yield us tools that will help us provide better care to our patients,” Hochstrasser said in the press release.
Founded in 1988,Biosite looks for early-stage research that it believes has commercial potential, then partner with those researchers with the goal of bringing their discoveries to market.
“If they have some intellectual properties or discoveries that they have at a very early stage and generally are not capable themselves of taking these discoveries much farther commercially, we will take their discoveries and generate immunoassays so that they can be validated in much larger patient samples,” Valkirs said.
Biosite’s first product to reach market was its Triage drugs of abuse panels, a drug-screening test, in 1992. During the next few years, tests for intestinal parasitic diseases and heart disease were also developed. In 1997, the company went public.
“We really are in this for the long haul to solve all of the diagnostic and prognostic issues that surround acute kidney injury and acute renal failure. So we’re leaving no stone unturned is the way to put it.”
That same year, it also licensed a protein biomarker from drug maker Scios called BNP, which eventually resulted in a diagnostic for congestive heart failure. Building on the success of BNP, Biosite created in 1999 its Discovery Institute aimed at building a portfolio of diagnostic protein markers.
Before Biosite announced its deal with HUG, its most recent agreement was with Oxford Genome Sciences to develop a test for relapsing colorectal cancer based on a multi-protein biomarker panel [See PM 04/04/06].
But its only very recently that Biosite has delved into the area of kidney injury research
There “aren’t that many people who are working on renal injury with respect to proteomic approaches,” Valkirs said.
He said there is a large market for a diagnostic tool that can predict potential kidney injuries. Each year, for example, about half of the 6 million patients admitted to intensive-care units need to be monitored for potential development of renal complications. If those patients stay in the ICU for one week, Valkirs said, that would translate to a market of 21 million diagnostic exams each year.
Last year, the company entered into a licensing agreement with the Cincinnati Children’s Hospital and Columbia for the use of neutrophil gelatinase-associated lipocalin, a biomarker that has the potential to allow clinicians to identify acute renal failure in hours rather than days.
Under the deal, Biosite will make antibodies to NGAL and test the resulting immunoassays on blood samples to evaluate commercialization potential.
Biosite’s deal with HUG complements the CCHC deal, Valkirs said.
“We really are in this for the long haul to solve all of the diagnostic and prognostic issues that surround acute kidney injury and acute renal failure,” Valkirs said. “So we’re leaving no stone unturned is the way to put it.”
Valkirs declined to release the financial details of the agreement. HUG researchers either declined to comment or did not respond to requests for an interview.
Hochstrasser declined to comment. Moll’s press office did not respond to a request for an interview.