Tuesday September 29, 8:43 am Eastern Time
Company Press Release
SOURCE: Biomerica, Inc.
Biomerica Receives U.S. FDA
Clearance To Market Its New Thyroid Disease Test
NEWPORT BEACH, Calif., Sept. 29 /PRNewswire/ -- Biomerica, Inc. (Nasdaq: BMRA - news)
today announced that the U.S. Food and Drug Administration (FDA) cleared to market its new free
T4 enzyme immunoassay test. The new test completes the Company's line of thyroid endocrinology
products.
The estimated worldwide market for all thyroid testing is approximately $600 million. Biomerica now
has a complete panel, including six FDA cleared tests, to accurately determine thyroid dysfunction.
This newest product determines the amount of free thyroxin (T4) circulating in the bloodstream, a
significant aid in the assessment of thyroid diseases. The panel of thyroid tests, developed and
produced by Biomerica, is important in determining and monitoring the presence of Graves' disease,
Hashimoto's thyroiditis and primary thyroid failure.
''This is an important addition to Biomerica's thyroid product line. In the U.S. free T4 is one of the
two major thyroid tests used in most clinical situations,'' said Biomerica's CEO Zackary S. Irani.
''We are committed to bringing new products to market quickly, efficiently and cost effectively. This
product complements our line of unique medical diagnostic tests for the laboratory.''
Biomerica's free T4 product is sensitive, highly specific, and cost effective, utilizing an industry
standard microwell format capable of determining results of 45 patient samples simultaneously. In
addition, the product does not utilize radioactivity, simplifying the handling of the test and eliminating
radioactive waste. Biomerica's thyroid endocrinology panel of tests has the flexibility of use in a
variety of laboratories for manual testing and automation.
Biomerica (Nasdaq: BMRA - news) is a global medical company devoted to developing,
manufacturing and marketing advanced medical diagnostic products for the early detection of
diseases. The products are used in hospitals, physician's offices and in the home for self-testing.
|
