ErlySign gets CDSCO nod for large-scale clinical trials for oral cancer detection technology
Overview
ErlySign, a Nagpur-based biotech start-up received the approval from the Central Drugs Standard Control Organization (CDSCO) for its active salivary biomarker study designed for early cancer detection.
Approval for Large-Scale Trial
- 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, ErlySign's active salivary biomarker study showcased remarkable performance, demonstrating a sensitivity of 98% and an unparalleled specificity of 100%.
Revolutionizing Technology
- The proprietary technology developed by ErlySign promises to revolutionise cancer detection through its advanced approach.
- The company has also 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.
Words from CEO: ErlySign
"Our mission is to provide an easy, accurate, affordable, and painless solution for early cancer detection. The active salivary biomarker study, now approved by CDSCO, marks a significant step towards achieving this goal. 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,” stated Shubhendra Singh Thakur, CEO, ErlySign.
Oral Cancer Detection Kit
- The company said that its 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.