Nagpur-based biotech startup ErlySign has received Breakthrough Device Designation from the US Food and Drug Administration for its saliva-based oral cancer early detection test, marking a significant regulatory milestone for the company.
The designation is granted to medical devices that demonstrate the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. The recognition places ErlySign’s diagnostic platform on an accelerated regulatory pathway in the United States and strengthens its prospects for global market entry.
ErlySign’s test is positioned as India’s first saliva-based, non-invasive diagnostic solution designed to detect precancerous changes before visible tumours or lesions appear in the oral cavity, lips, tongue, throat or larynx. The test requires a small saliva sample of 2–5 ml and delivers results within 10–15 minutes, enabling rapid screening in outpatient clinics and community healthcare settings.
The technology has undergone large-scale, multi-city clinical validation in collaboration with Healthcare Global and Rashtrasant Tukdoji Cancer Hospital. Trials involving around 1,000 patients across Nagpur, Bengaluru and Ranchi reported 98% sensitivity and 100% specificity, supporting the test’s diagnostic accuracy.
With oral cancer remaining one of the most prevalent cancers in India, particularly among tobacco users, early detection tools that are rapid, accessible and non-invasive could play a critical role in improving survival outcomes and reducing treatment burden.
