Co-Diagnostics JV CoSara Receives Indian Regulatory Approval for Five Diagnostic Assays
CoSara Saragene™ tests for tuberculosis, malaria, hepatitis B, hepatitis C, and human papillomavirus now available for sale and distribution as in vitro diagnostics
The Saragene™ tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) meet the requirements of the
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
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
“We are honored to be the manufacturer of the first indigenous PCR-based diagnostic kits in India,” said Mr.
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.
Head of Investor Relations