Co‑Diagnostics expands in South Asia
Co‑Diagnostics is rolling its PCR Pro and SARAGENE molecular tests into Bangladesh, Pakistan, Nepal and Sri Lanka as part of a push into a $13B market for rapid infectious and genitourinary diagnostics. The move underscores growing demand for PCR‑based screening that cytology labs will increasingly need to interface with. (prnewswire.com)
CoSara Diagnostics is the Indian joint venture formed between Co‑Diagnostics, Inc. and Ambalal Sarabhai Enterprises Limited (ASE Group). (prnewswire.com) Co‑Dx’s at‑home and point‑of‑care PCR platform, including the PCR Pro instrument and associated test kits, remains subject to review by the FDA and other regulatory bodies and is not yet available for sale. (prnewswire.com) Co‑Diagnostics submitted an Emergency Use Authorization package for the PCR Pro device and a COVID‑19 test to the U.S. FDA on December 27, 2023, and reported clinical evaluations showing detection from anterior nasal swabs in approximately 30 minutes. (prnewswire.com) The company has stated the development pipeline for the PCR Pro platform explicitly includes assays for tuberculosis and human papillomavirus (HPV) as well as an upper‑respiratory multiplex panel covering influenza A/B, COVID‑19 and RSV. (prnewswire.com) CoSara says it is establishing distribution channels by evaluating regulatory pathways, identifying priority customer segments and engaging regional partners, and it has scheduled a virtual distributor information session in Q2 2026 with an in‑person distributor meeting and training event planned later in summer 2026. (prnewswire.com) The SARAGENE product line referenced for commercialization comprises real‑time PCR assays such as HBV and HCV tests optimized for plasma/serum samples, according to CoSara’s product information, while the PCR Pro test menu uses Co‑Dx’s patented Co‑Primers real‑time PCR chemistry. (cosara.in)
