CDSCO approves ErlySign’s oral cancer detection technology for large-scale clinical trials

New Delhi: ErlySign announces a significant milestone in the fight against cancer with approval from the Indian regulatory agency Central Drugs Standard Control Organisation (CDSCO) for its active salivary biomarker study designed for early cancer detection.

Following a comprehensive year-long investigation and based on in-house validation data of 150 test samples, the Indian Regulatory Authority CDSCO has granted permission to ErlySign to proceed with large-scale clinical trials. Notably, during the initial studies, The active salivary biomarker study showcased remarkable performance, demonstrating a sensitivity of 98 per cent and an unparalleled specificity of 100 per cent.

The proprietary technology developed by the start-up promises to revolutionise cancer detection through its advanced approach with patents secured in both the US and India for their oral cancer detection kit. Moreover, the company's dedication to advancing cancer diagnostics extends to its lung cancer detection kit, for which a patent is currently pending.

In a recent development, the start-up launched an automated multi-sample reader for its oral cancer detection kit. This streamlines the testing process, allowing multiple tests to be processed within a mere 15-20 minutes.

Shubhendra Singh Thakur, CEO, ErlySign, said, “With our technology, individuals can now detect precancerous conditions even before the appearance of any oral lesion or tumour formation, empowering proactive intervention and potentially saving countless lives.”

The oral cancer detection kit offers a semi-quantitative approach, allowing for the assessment of pre-cancerous conditions through saliva biomarkers. Results are provided as low, moderate, or high risk, providing individuals with actionable insights into their cancer risk profile.