Biosite (San Diego) reported that the FDA has granted a Clinical Laboratory Improvements Amendment (CLIA) waiver for its Triage BNP test, which it said would result in "substantially expanding" physicians' access to the test, designed for the diagnosis and assessment of patients with symptoms of heart failure.
The Triage BNP Test is a rapid immunoassay blood test that aids in the diagnosis of congestive heart failure, assessment of disease severity and in the risk stratification of patients with acute coronary syndromes.
Biosite said the CLIA waiver would expand access to the test among physicians' offices and decentralized hospital sites of service, allowing more patients to benefit from the 15-minute blood test.
"This is a significant competitive advantage for us," Biosite Chairman and CEO Kim Blickenstaff told Diagnostics & Imaging Week, adding that it is a "significant reduction of barriers." He noted that there are no other companies with CLIA waivers for the BNP test.
In other cardiac test news, Olympus (Melville, New York) said it received FDA clearance for its C-reactive protein (CRP) Latex assay as an independent cardiac risk marker. It said that measurement of CRP "can have a role in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases."
The company said that "high sensitive application measurements, when used in conjunction with traditional clinical laboratory evaluations, may be useful as an independent marker of prognosis for recurrent events in patients with either stable coronary disease or acute coronary syndromes."
The Olympus CRP Latex assay offers three applications covering a variety of measuring ranges to quantify C-reactive protein in human serum, including normal (5 mg/L to 170 mg/L), sensitive (cardiac) (0.5 mg/L to 20 mg/L) and highly sensitive (neonatal) (0.05 mg/L to 2.00 mg/L). The assay is designed for use on Olympus' full line of chemistry-immuno analyzers, including the AU400/400e, AU600, AU640/640e, AU2700 and AU5400.
Biosite secured FDA clearance to market its BNP test in November 2002. It is one of three licensees for the technology from Scios (Fremont, California), which became a subsidiary of Johnson & Johnson (New Brunswick, New Jersey) in 2003. The other two licensees are Roche Diagnostics (Indianapolis) and Bayer Diagnostics (Tarrytown, New York).
"Receiving waived status for the Triage BNP test is a significant milestone that nearly triples the number of cardiology, family practice and internal medicine practices with access to BNP testing," Blickenstaff said in a company statement. "While approximately 103,000 U.S. physician offices laboratories can perform .... the Triage BNP Test, our efforts will focus on the 55,000 physician practices that most commonly treat heart failure patients."
Previously, use of the test in physicians' office laboratories was limited to the approximately 18,000 facilities licensed to perform moderately complex tests, Biosite said.
In 2004 alone, sales of the Biosite Triage test with just FDA clearance totaled $165 million, Blickenstaff told D&IW, giving Biosite about "80% of the market."
"It [has generated] well over half our revenues in the four short years in the marketplace," he said, noting that he believes the physician-office market "could be equivalent to the hospital market."
BNP, or b-type natriuretic peptide, is a naturally occurring hormone in the body. When the heart is unable to pump efficiently, BNP is produced to ease the workload, the company said. BNP "appears to relax blood vessels .... increase the excretion of sodium and fluid and decrease neurohormones that lead to vessel constriction, fluid retention and elevated blood pressure.
Because the Triage BNP test is completed in about 15 minutes, the company said it is "well-suited" for use in physician office laboratories and other point-of-care sites.
Unlike Roche and Bayer, which operate on large immunoassay systems, Blickenstaff said the Biosite Triage Meter device is "about the size of a telephone and operates on batteries" The procedure involves placing a few drops of blood on a disposable test device, which then is inserted into the Biosite Triage Meter. The instrument scans the test device and uses fluorescence technology to measure the level of BNP in a patient's blood sample.
"The capacity to rapidly measure BNP in clinical settings such as physician offices and outpatient clinics will provide clinicians with an important tool to catch heart failure in the earlier stages and improve patient management," Norman Paradis, MD, vice president of medical affairs at Biosite, said in a statement.
The American Heart Association (Dallas) estimates that about 550,000 new cases of heart failure were diagnosed in 2002; however, it said that many are not diagnosed until the disease has reached an advanced stage, according to Biosite. The disorder has been estimated to be the cause for 12 million to 15 million physician office visits and 6.5 million hospital days annually.