Co-Diagnostics, a renowned US-based molecular diagnostics company, having a patented, unique platform to develop diagnostics tests reportedly announced that CoSara Diagnostics, the company’s JV for production, has received regulatory clearance for five tests to be produced and marketed as IVDs (in vitro diagnostics) from its unit located in Ranoli, India.

The Saragene tests for malaria, Mycobacterium tuberculosis, human papillomavirus (HPV), hepatitis B and hepatitis C met the demands of the CDSCO (Central Drug Standard Control Organization) MDR (Medical Device Rules) 2017 to be produced and sold as IVDs.

The CDSCO authorization was granted after the CoSara manufacturing facility was completed and a proper inspection of the plant location, presentation of quality system, technology, procedures, product validation data, and performance assessment by an independent CAP and NABL accredited laboratory.

The new licenses and regulatory clearance enable the company to produce and sell these tests for the detection of the respective microorganisms and pathogens

Dwight Egan, CEO of CoSara Diagnostics, stated that India would soon become the biggest healthcare industry on the planet. The country would be marked as the best place for production and distribution of CoPrimer-powered products.

Egan further added that having the ability to sell fully authorized IVDs to the Indian market represents the next step in the company’s growth as it establishes Co-Diagnostics to be a top innovator of affordable, high-quality diagnostics solutions. The company is thrilled to be taking this step in its growth with such a well-known partner. CoSara is now eager to see outcomes on the effort and time it has spent to get it up to this point.

The distributors of the company have initiated the pre-orders of these five IVDs. The company expects to witness heavy sales growth in coming time. It also has its exclusive production rights in the country for the entire menu of Co-Diagnostics infectious disease molecular diagnostics kits. These kits are designed by Co-Diagnostics through their patented CoPrimer technology platform.    

Source credit: http://codiagnostics.com/co-diagnostics-jv-receives-indian-regulatory-approval-for-5-assays/