Actorius Announces India's First CDSCO‑Approved Clinical CTC Assay
Actorius Innovations and Research Pvt. Ltd has launched OncoDiscover® CTC liquid‑biopsy as the first circulating tumour cell (CTC) assay in India to receive formal approval from the Central Drugs Standard Control Organisation (CDSCO). The company holds the requisite manufacturing and marketing licences under the Medical Devices Rules, making it the first indigenously developed, patented CTC test cleared for clinical application in the country.
The assay’s regulatory legitimacy is complemented by two additional quality pillars. It is certified to ISO 13485:2016 by Intertek, confirming that design, development, manufacturing and post‑market processes meet the global quality‑management standard for medical devices. Moreover, the laboratory that generates the test results is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), independently verifying its technical competence.
Since its introduction, Actorius has performed more than eleven thousand (11,000) OncoDiscover® tests across clinical sites. The platform’s scientific credibility is reinforced by 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).
Dr Jayant Khandare, Founder, Managing Director and Chief Scientific Officer of Actorius, emphasizes that liquid‑biopsy technologies must transition from research novelty to regulated, reproducible clinical tools. Under his leadership, the company has amassed more than 150 scientific publications and multiple patents related to CTC detection and analysis.
The three‑standard framework—CDSCO approval, ISO 13485 certification and NABL accreditation—provides clinicians, hospitals and patients with a clear, verifiable benchmark of reliability when using CTC enumeration to monitor treatment response, detect minimal residual disease, assess relapse risk and guide therapy decisions, especially where conventional imaging may fall short.
Actorius positions this integrated approach as a template for the broader Indian liquid‑biopsy market, arguing that the presence of all three standards will become the practical definition of readiness for clinical scale across the country’s oncology diagnostics landscape.
About Actorius Innovations and Research
Actorius is an Indo‑US biotechnology firm focused on advancing CTC technologies for cancer detection, monitoring and intervention. It operates research facilities in Pune and maintains a growing portfolio of clinical and scientific work that bridges laboratory discovery with regulated clinical application.