SALT LAKE CITY--(BUSINESS WIRE)--Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today the inauguration of its Indian joint venture facility for manufacturing in Ranoli, India.
The manufacturing facility for CoSara Diagnostics Pvt Ltd (CoSara) is one of the first facilities for manufacturing molecular diagnostics in India and is intended to meet both current and future requirements for medical device manufacturing, which are expected to be implemented by the Indian government over the next few years. The facility was also designed to be in compliance with ISO 13485:2016, cGMP (Current Good Manufacturing Practices) regulations, and audits for WHO qualification and CE-marking of diagnostics products.
Mr. Dwight Egan, CEO of Co-Diagnostics Inc., and Mr. Mohal Sarabhai, CEO of Synbiotics Pvt Ltd, inaugurated the facility on April 8, 2019. The inauguration was attended by officers and department heads of CoSara, Co-Diagnostics, and Synbiotics, as well as suppliers, distributors, and other invited guests. Company personnel also conducted additional trainings, and attended press conferences and other receptions to help introduce CoSara to the Indian market.
“We are honored to be a part of such an auspicious occasion with such prestigious partners in this endeavor, and proud of the hard work of all involved that has brought us to this point,” remarked Mr. Egan. “We believe that the new facility, its high standards of quality, and room for future expansion will accelerate our infectious disease initiative as it addresses the need for diagnostic solutions in one of the largest health care markets in the world.”
Mr. Sarabhai commented, “CoSara brings cutting-edge molecular technology to India through this joint venture. The opening of this facility is truly well-timed and sets in well with the ‘make in India’ initiative, as well as the almost imperative transition to NAAT-based screening for blood banks and management of diseases. This will be a breakthrough for highly accurate diagnostics which lead to early detection and conclude with well-timed treatment responses.”
CoSara has the exclusive manufacturing rights in India for the complete menu of Co-Diagnostics infectious disease molecular diagnostics kits, designed by Co-Diagnostics using their patented CoPrimer™ technology platform. The initial market launch includes in vitro diagnostic kits for the detection of mycobacterium tuberculosis (TB), drug-resistant tuberculosis, malaria, hepatitis B, hepatitis C, human papillomavirus, and HIV. Future tests include expansion into the oncology and hemorrhagic fever markets and several other hospital-acquired infectious organisms.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in liquid biopsy and SNP detection, (iv) use of the Company’s liquid biopsy tests by laboratories, (v) capital resources and runway needed to advance the Company’s products and markets, (vi) increased sales in the near-term, (vii) flexibility in managing the Company’s balance sheet, (viii) anticipation of business expansion, and (ix) benefits in research and worldwide accessibility of the CoPrimer technology and its cost-saving and scientific advantages. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.