CoSara gets exclusive market rights
Utah-based Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, has inaugurated a joint venture facility for manufacturing in Ranoli, Gujarat.
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.
Dwight Egan, CEO of Co-Diagnostics, and Mohal Sarabhai, CEO of Synbiotics Pvt Ltd, inaugurated the facility on 8 April 2019.
“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 Egan in a release on 16 April 2019.
“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,” he said.
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.
Co-Diagnostics, a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. fiinews.com