SALT LAKE CITY–(BUSINESS WIRE)–Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, proprietary platform for the development of molecular diagnostics, announced today a product shipment to India containing tests to be sold as Research Use Only as well as others to be used in validation studies in that country.
The validation study for the most recent iteration of the Company’s test for tuberculosis will be conducted at the All India Institute of Medical Sciences (“AIIMS”). With nearly 20% of the world’s tuberculosis cases in India, a substantial market exists in that country for affordable, accurate diagnostic solutions. Results of the study will be used to complete the application to the Central Drugs Standard Control Organization (“CDSCO”), the Indian regulatory body for pharmaceuticals and medical devices, to allow for free sale of the diagnostic test across the country. Prior to approval by the CDSCO the tests will be sold as Research Use Only, until authorization has been granted for use as an in-vitro diagnostic. Ten thousand such tests were also included with the shipment to be sold by CoSara Diagnostics Pvt Ltd, the Company’s Joint Venture in India.
The shipment also contained other Co-Diagnostics products to be used in third party performance validation studies, including a test for human papillomavirus (HPV). Certain strains of HPV, HPV 16 and HPV 18, are known to account for nearly 70% of cases of cervical cancers in women. The HPV test included in the shipment was built on the Company’s patent-pending CoPrimer™ technology specifically to identify the existence of these two strains of the virus.
Dwight Egan, Co-Diagnostics CEO, remarked, “Completion of the AIIMS study is the final hurdle before being able to pursue approval by CDSCO, and we are confident that the results will bear out the quality and competitiveness of Co-Diagnostics’ products. The distribution network already in place with CoSara Diagnostics is eager to commence sales of the newest version of our flagship tuberculosis test. And with nearly a half million new cases every year, and one quarter million female deaths worldwide per year from cervical cancers, we also look forward to being able to introduce our HPV test into the addressable market.”
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that has developed and intends to manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), and to sell diagnostic equipment from other manufacturers as self-contained lab systems.
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