Press Release – Actorius Innovations and Research Pvt. Ltd
Actorius Innovations and Research Pvt. Ltd, an Indo‑US biotechnology company, announced that its OncoDiscover® liquid‑biopsy platform is the first circulating tumour cell (CTC) assay in India to receive formal approval from the Central Drugs Standard Control Organisation (CDSCO). The CDSCO approval confirms that the technology has undergone regulatory scrutiny for safety, performance and intended clinical use under the Medical Devices Rules, and the company holds the requisite manufacturing and marketing licences.
The assay is further underpinned by two internationally recognised quality frameworks: ISO 13485:2016 certification issued by Intertek, which validates that design, development, manufacturing and post‑market processes meet global medical‑device quality standards, and accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL), which independently verifies the technical competence of the laboratory generating the test results.
Since its launch, Actorius has performed more than eleven thousand (11,000) OncoDiscover® tests across clinical sites, and the company’s scientific work has been showcased in over one hundred (100) presentations at leading oncology conferences, including the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), the European Society for Medical Oncology (ESMO) and the International Society for Liquid Biopsy (ISLB).
The press release highlights that the combination of regulatory clearance, ISO‑based quality management and NABL laboratory accreditation provides clinicians, hospitals and patients with a clear benchmark of reliability when using CTC enumeration to monitor treatment response, detect minimal residual disease, assess relapse risk and guide therapy decisions—areas where conventional imaging may fall short.
Founder, Managing Director and Chief Scientific Officer Dr Jayant Khandare, whose background spans polymer chemistry, biomaterials and oncology diagnostics, is quoted as having advocated for liquid‑biopsy platforms that move beyond research novelty to become regulated, reproducible clinical tools. Dr Khandare has authored more than 150 scientific publications, holds multiple patents, and leads the company’s research facilities in Pune.
Actorius positions the triple‑standard framework as the emerging definition of readiness for clinical‑scale liquid‑biopsy and advanced oncology diagnostics in India, arguing that the presence of CDSCO approval, ISO 13485 certification and NABL accreditation raises the overall quality bar for cancer care across the country.
The release notes that it is distributed under an arrangement with NRDPL and that PTI assumes no editorial responsibility for its content.