Biosite plans diagnostic tests in six new areas

By Jennifer Lanning Drey

Eugene, Ore., June 21 - Biosite, Inc. is developing new diagnostic testing products in six areas in an effort to broaden its revenue base and decrease its reliance on any one product, said Dr. Gunars Valkirs, senior vice president of discovery for Biosite.

The company's objective is to develop diagnostic panels in areas where testing is limited or not currently available, Valkirs said Wednesday at the Nasdaq investor program.

"By identifying high value opportunities where there is a diagnostic need and no diagnostic [test] exists, we'll be able to command premium prices for those products," said Valkirs.

"The novel nature of these products also reduces the company's threat because we're working in areas where no existing diagnostic is present, and we don't believe anybody is actually attempting to develop diagnostics for any of these products," he also said Wednesday.

The Food and Drug Administration is currently reviewing a myeloperoxidase assay developed by Biosite to diagnose and determine the prognosis of patients who suffer from adverse cardiac events.

In addition, the company is in negotiations with the FDA regarding its stroke panel diagnostic, which is approved and being launched in Europe. Biosite withdrew its first Pre-Market Approval application in the United States due to inherent problems with the application, Valkirs said.

The FDA is providing Biosite with guidance on how to design a new protocol, and the company intends to begin another clinical trial and submit a new Pre-Market Approval, he said.

Biosite is also developing early and later stage testing products for patients with sepsis. The first will aim to diagnose the disease upon a patient's arrival in an emergency room, and the later will be a prognostic test used to determine which sepsis patients are likely to progress to severe disease.

Biosite has enrolled 1,100 patients at 10 sites in a discovery clinical trial for the products and expects to begin a validation trial in the second half of the year, Valkirs said.

Further back in its pipeline, the company is developing a diagnostic test to detect kidney injury. Kidney injury usually precedes acute renal failure by two to three days, and an early diagnosis could allow for therapeutic intervention, Valkirs said.

"If you can give the physician two to three days lead time, it's very likely that therapeutic intervention will enable the minimization of damage to the kidney," he said.

Biosite has also begun development of a colorectal screening panel, which is its first diagnostic test for a chronic disease.

The company's initial objective is to develop a test that will diagnose the reoccurrence of colorectal cancer in patients who have previously been diagnosed and been treated for it, and the company believes the test could possibly be used to monitor patients on a quarterly basis.

Biosite's eventual goal is to also develop a colorectal screening panel that could be used in asymptomatic patients.

"If we actually were successful in that application, we would probably find that the test would be used in every person over the age of 50 to screen out the presence of colorectal cancer," Valkirs said.

The company's final diagnostic product in development is a testing panel to diagnose the cause of abdominal pain.

BNP Triage will provide model

Biosite will use the commercialization process of its BNP Triage product line as a model for launching its new products, Valkirs said Wednesday.

"We'll leverage our growing market presence in order to get these new tests adopted clinically, and we've already demonstrated we can do that with the BNP test, so that will be our model going forward for how to drive clinical adoption of these novel tests," said Valkirs.

Biosite's BNP Triage product line, which is used to diagnose cardiac patients in four areas, provides the company with its current cash flow.

Biosite is a San Diego biomedical company commercializing proteomics discoveries for the advancement of medical diagnosis. Biosite's Triage rapid diagnostics are used in about 50% of U.S. hospitals and in more than 50 international markets.

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