MIAMI LAKES, Fla., Jan. 21, 2015 (GLOBE NEWSWIRE) -- ERBA Diagnostics, Inc. (NYSE MKT:ERB), has attained CE Mark clearance for the HB Vario A1c detection system and associated reagents. Monitoring A1c values can help healthcare providers manage complications from diabetes in patients.
The CE Mark registration provides marketing authorization in the 28 member states of the European Union and can be used for registration in additional countries who recognize the CE Mark. Following CE Mark clearance in December 2014, ERBA Diagnostics has commenced a limited launch of the HB Vario A1c detection system and associated reagents in Europe through its direct sales team and a limited launch in India through its distributor, and indirect parent company, Transasia Bio-Medicals.
"This clearance provides our customers with a valuable new product, which we will be able to commercialize through our existing global network of distributors and direct sales representatives," said Suresh Vazirani, Executive Chairman of ERBA Diagnostics. "The proprietary system and associated reagents are ideally suited for the underserved market of smaller hospitals, physicians clinics and reference labs who are looking for more cost-effective and accurate options. We are in the early launch phase and look forward to a broader release later this year."
The Hb-Vario is capable of processing up to 10 samples at a time with an assay time of just around 4 minutes per sample. The Hb-Vario can sample from a wide number of sample tubes. The touchscreen of the Hb-Vario, the interactive software and user-friendly features makes the unit extremely easy to use.
Diabetes continues to be one of the major challenges worldwide to the healthcare industry, a challenge that is pronounced in developing countries and emerging markets. It is currently estimated by the World Health Organization that 347 million people worldwide are afflicted with diabetes.
About ERBA Diagnostics, Inc.
ERBA Diagnostics, Inc. (NYSE MKT:ERB), is a fully integrated in vitro diagnostics company, offering a comprehensive suite of clinical testing products throughout the U.S. and emerging markets. The Company serves as a one-stop shop for the testing needs of the growing number of smaller hospitals, reference labs, and physician clinics. ERBA Diagnostics' line of proprietary and automated instruments, test kits, and reagents provide customers with autoimmune, infectious diseases, clinical chemistry, hematology, and diabetes testing. www.erbadiagnostics.com
Safe Harbor Statement
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of ERBA Diagnostics, Inc., including, without limitation, the risks and uncertainties related to: the ability of ERBA Diagnostics to more broadly commercially launch the HB Vario and associated reagents when expected, or at all; the impact of the anticipated timing of the more broad commercial launch of the HB Vario and associated reagents on the judgments and estimates ERBA Diagnostics has made with respect to its financial condition, operating results and cash flows; ERBA Diagnostics' ability to successfully market the HB Vario and associated reagents; the ability of the HB Vario and associated reagents to perform as expected; the ability of the HB Vario and associated reagents to complement and enhance ERBA Diagnostics' existing portfolio of instruments and reagent kits; the ability of the HB Vario and associated reagents to be a source of revenue growth for ERBA Diagnostics in the future; constantly changing, and ERBA Diagnostics' compliance with, domestic and international governmental regulation; ERBA Diagnostics' ability to achieve cost advantages from its own manufacture of instrument systems and reagents test kits; and economic, competitive, political, governmental and other factors affecting ERBA Diagnostics and its operations, markets and products. In addition to the risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in ERBA Diagnostics' filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading "Risk Factors" in such filings.