Actorius Innovations & Research Pvt. Ltd., an Indo‑US biotechnology firm based in Pune, announced that its OncoDiscover® circulating tumour cell (CTC) liquid‑biopsy assay has received formal approval from the Central Drugs Standard Control Organisation (CDSCO). This marks the first CDSCO‑approved, indigenously developed, patented CTC test cleared for clinical application in India, and the company holds the requisite manufacturing and marketing licences under the Medical Devices Rules. In addition to regulatory clearance, the assay is supported by ISO 13485:2016 certification issued by Intertek, confirming that design, development, manufacturing and post‑market processes meet the global quality‑management standard for medical devices, and by National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation, which independently verifies the technical competence of the laboratory that generates the test results. The three‑fold framework—CDSCO approval, ISO certification and NABL accreditation—provides clinicians, hospitals and patients with a clear benchmark of regulatory legitimacy, organisational quality systems and analytical reliability. To date, Actorius has performed more than eleven thousand OncoDiscover® tests across India and has disseminated its findings through over one hundred scientific presentations at leading oncology conferences, including ASCO, AACR, ESMO and ISLB. The company’s founder, Dr. Jayant Khandare, who serves as Managing Director and Chief Scientific Officer, brings a background in polymer chemistry, biomaterials and oncology diagnostics, and has authored more than 150 scientific publications and holds multiple patents. Dr. Khandare emphasizes that liquid‑biopsy platforms must transition from research novelty to regulated, reproducible clinical tools, and that the alignment of regulatory approval, quality‑system certification and laboratory accreditation constitutes the essential pathway for trustworthy cancer diagnostics in India. The press release is distributed under an arrangement with NRDPL, with PTI noting no editorial responsibility for the content.