Biosite (San Diego) said it is developing a second-generation Triage Cardio ProfilER Panel that will include myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. The company said it believes the addition of MPO can advance the diagnostic utility of the product, which is used for emergency assessment of chest pain patients. The Triage Cardio ProfilER Panel currently measures the levels of troponin I, CK-MB, BNP and myoglobin in blood and is used as an aid in the diagnosis of myocardial infarction, diagnosis and assessment of severity of congestive heart failure and risk stratification of patients with acute coronary syndromes. Biosite said it expects to begin clinical trials for the Triage Cardio ProfilER Panel that will include MPO in 3Q05. Pending the completion of clinical trials for the product, the company said it anticipates filing a premarket 510(k) notification with the FDA by 4Q05.
Power3 Medical Products (The Woodlands, Texas), a proteomics company, reported that to date, it has enrolled 137 participants from three participating locations — the Clinical Research Center of Houston, Obstetrical and Gynecological Associates at Mercy Women's Center in Oklahoma City and NYU Medical Center — in its multi-site clinical validation study for the early detection of breast cancer. The validation study involves the collection of nipple aspirate fluid (NAF) and blood serum samples from several hundred women. The NAF fluid and blood serum samples are collected at the three clinical sites and shipped to Power3 for analysis, using proprietary technologies that monitor a select group of breast cancer related protein biomarkers. The company believes that these specific NAF and blood serum protein profiles can be used to determine if a woman has a normal proteomic pattern or one suggestive of cancer or benign disease.