Biocircuits regulatory update

BIOC filed a 510(k) with the FDA to market its Thyroid Stimulating Hormone (TSH) assay. The assay is designed for use with BIOC's IOS immunodiagnostic system for point-of-care diagnosis. BIOC said that more than 21 million TSH tests are ordered every year by physicians, of which two-thirds are sent to outside laboratories.

BIOC already sells a combined T4 and T Uptake assay to assess thyroid function. The company took $96,000 worth of orders for the two assays within the first month of sales, of which BIOC booked $45,000 in first quarter results. ...