Co-Diagnostics, Inc. (Nasdaq: CODX) announced that CoSara Diagnostics Pvt. Ltd., its joint venture in India, has initiated clinical studies for a tuberculosis test using the CoSara PCR Pro instrument.

The CoSara PCR Pro instrument, a CoSara-branded version of the Co-Dx PCR Pro point-of-care device, is being deployed to select laboratories across India for tuberculosis testing evaluation. The platform uses Co-Diagnostics' patented Co-Primers technology and is designed to deliver real-time PCR results in approximately 30 minutes via a mobile application.

PCR Pro instruments, mycobacterium tuberculosis test kits, and proprietary sample preparation instruments have been shipped to CoSara. Co-Dx PCR platform products, including test kits and the sample lysis instrument, are expected to be manufactured and distributed in India under the CoSara brand.

CoSara Diagnostics was established in 2017 as a joint venture between Co-Diagnostics and Synbiotics Ltd., a subsidiary of Ambalal Sarabhai Enterprises Ltd. The company is based in India and focuses on molecular diagnostic instruments and assays.

The Co-Dx PCR platform remains subject to regulatory review and authorization in applicable jurisdictions, including the U.S. FDA, and is not yet available for sale.