Actorius Innovations and Research has built its OncoDiscover®️ CTC liquid biopsy on precisely these three pillars. The result is India’s first and only CDSCO-approved clinical circulating tumour cell assay, supported by an ISO 13485:2016-certified quality management system and a NABL-accredited laboratory.
Each standard answers a different question of confidence. CDSCO approval establishes that the technology has undergone formal regulatory scrutiny for safety, performance and intended clinical use. Actorius Innovations & Research Pvt. Ltd. holds the relevant manufacturing and marketing licences under the Medical Devices Rules, confirming its status as the first indigenously developed, patented CTC test cleared for clinical application in the country. ISO 13485:2016 certification, issued by Intertek, ensures that design, development, manufacturing and post-market processes meet the global quality management standard required for medical devices. NABL accreditation independently verifies the technical competence of the laboratory that generates the results. These are not overlapping claims. One confirms regulatory legitimacy, another organisational quality systems, and the third analytical reliability.
From a scientist’s perspective, healthcare innovation remains incomplete until it is matched by validation, reproducibility and quality infrastructure. Circulating tumour cells sit at the frontier of understanding metastasis and minimal residual disease. Before any such technology can responsibly guide treatment, it must clear the thresholds of regulatory clearance, quality systems and laboratory competence. Dr Jayant Khandare, Founder, Managing Director and Chief Scientific Officer of Actorius, has long argued that liquid biopsy platforms must move beyond research novelty into regulated, reproducible clinical tools. OncoDiscover®️ was developed with that principle at its core.
The company has already performed more than eleven thousand tests, supported by over a hundred scientific presentations at ASCO, AACR, ESMO and ISLB, while maintaining the triple framework of CDSCO approval, ISO 13485 certification and NABL accreditation.
For oncologists, the combination offers a clearer signal of reliability when CTC enumeration is used to monitor treatment response, detect minimal residual disease, assess risk of relapse and guide therapy decisions; insights that conventional imaging often misses. For hospitals and diagnostic networks, it provides a practical benchmark against which other liquid biopsy offerings can be evaluated. For patients, it translates into greater assurance that the test they undergo rests on independently verified regulatory, quality and laboratory foundations rather than promotional claims alone.
The larger significance lies beyond any single company. As liquid biopsy and advanced oncology diagnostics expand across India, the presence of all three standards is becoming the practical definition of readiness for clinical scale. Actorius’ approach with OncoDiscover®️ shows how an Indian innovator can build technology that meets this emerging expectation rather than treating certifications as afterthoughts.
In a field where a single circulating tumour cell can carry the potential for relapse or metastasis, the demand for trustworthy, reproducible and regulated diagnostics continues to intensify. The alignment of CDSCO approval, ISO 13485:2016 quality systems and NABL laboratory accreditation offers one clear pathway for the industry to meet that demand,and in doing so, raise the quality bar for cancer care across the country.
About Actorius Innovations and Research
Actorius Innovations and Research is an Indo-US biotechnology company focused on advancing circulating tumour cell technologies for cancer detection, monitoring and intervention. With research facilities in Pune and a growing body of clinical and scientific work, the company continues to bridge laboratory discovery with regulated clinical application. At its helm is Dr Jayant Khandare, Founder, Managing Director and Chief Scientific Officer, whose career spans polymer chemistry, biomaterials and oncology diagnostics. With more than one hundred and fifty scientific publications and multiple patents to his name, Dr Khandare has long advocated that meaningful innovation in cancer care must rest on rigorous validation, quality systems and reproducible science; principles that now define both Actorius and the OncoDiscover®️ platform.
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