5 December 2019 - - US-based molecular diagnostics company Co-Diagnostics, Inc.'s (NASDAQ: CODX) CoSara Diagnostics Pvt Ltd joint venture for manufacturing has obtained regulatory clearance for five tests to be manufactured and sold as in vitro diagnostics from their facility in Ranoli, India, the company said.

The Saragene tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus meet the requirements of the Central Drug Standard Control Organization Medical Device Rules 2017, File no. 29/Misc./3/2017-DC, to be manufactured and sold as IVDs.

CDSCO approval was granted following the completion of the CoSara manufacturing facility and a comprehensive inspection of the location, presentation of the technology, quality system, procedures, product validation data and performance evaluation by an independent NABL and CAP accredited laboratory.

The licenses and regulatory clearance allow CoSara for the first time to manufacture and sell the tests for the detection of the respective pathogens and microorganisms.

CoSara distributors have begun taking pre-orders for the five IVDs, and the company expects sales to ramp quickly. The JV 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.

Additional tests which are expected to be submitted to the CDSCO for approval consist of those for drug-resistant tuberculosis, HIV and more, including a multiplexed panel specifically for blood-bank screening.

The CoSara plant is one of the first facilities for manufacturing molecular diagnostics in India and has been designed to meet both current and future requirements for medical device manufacturing, which are expected to be implemented by the Indian government.

CoSara is a joint venture between the company and Synbiotics Pvt Ltd, a group company of Asence Inc, a US company that specializes in supplying pharmaceutical products to international markets across 35 countries.

Asence and Synbiotics are both subsidiaries of Ambalal Sarabhai Enterprises Ltd., a continuation of one of the oldest and most respected manufacturing institutions in India in operation TODAY.

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new 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.