New Delhi | 17 December 2025: ErlySign, the Nagpur‑based biotech startup developing India’s first salivary biomarker–based screening test for early‑stage oral cancer, today announced the successful completion of its large‑scale clinical trial conducted across 1,000 patients. With this milestone achieved, the company is now preparing to launch its first commercial product by April 2026.
The multi‑centre clinical study was conducted across leading cancer care institutions, including HCG Nagpur, HCG Ranchi, HCG Bangalore, and the Regional Cancer Hospital (Rashtrasant Tukdoji Cancer Hospital, Nagpur) – a Government of India–recognised centre of excellence.
Strong Scientific Validation Across Multiple Study Phases
Interim analyses from the large‑scale trial mirrored the findings of ErlySign’s earlier small‑scale study, confirming:
- High reproducibility
- Strong diagnostic consistency
- Scientifically validated performance
- Robust biomarker reliability across diverse patient groups
This consistency across independent studies reinforces the scientific validity of ErlySign’s approach to early oral cancer detection using saliva‑based biomarkers.
Breakthrough Finding: Detecting High‑Risk Cases Before Clinical Symptoms
A notable outcome of the study was the identification of individuals flagged as high‑risk by ErlySign’s test despite being clinically assessed as healthy.
Follow‑up monitoring over six months later confirmed these cases as positive, demonstrating the test’s ability to detect extremely early‑stage abnormalities that traditional clinical examinations may miss.
This finding highlights ErlySign’s potential to shift India’s oral cancer landscape from late‑stage diagnosis to true early detection and prevention.
Shubhendra Singh, CEO, ErlySign, said: “This trial success strengthens our belief that early detection can truly change cancer outcomes. Oral cancer claims more than 1,45,000 lives annually in India, largely due to delayed diagnosis. With our upcoming product, detecting precancerous changes will be possible in a simple, painless 15‑minute saliva test; long before tumors develop.”
Dr (Prof) U. S. Vishal Rao, distinguished Head & Neck Surgical Oncologist, Robotic Surgeon, and Member, Governing Council, National Cancer Grid (India), added: “India loses over 1.45 lakh lives every year to oral cancer – deaths that are largely preventable. ErlySign’s salivary biomarker test is the kind of innovation our country urgently needs. The fact that the test flagged clinically healthy individuals who later developed lesions is particularly compelling. This is the paradigm shift we need: from reactive treatment to genuine prevention.”
Next Steps: Regulatory Approvals, Manufacturing Scale‑Up & Commercial Rollout
With the successful trial outcomes, ErlySign is now:
- Initiating the CDSCO regulatory approval process
- Scaling manufacturing for commercial deployment
- Building clinical partnerships across India
- Preparing for nationwide rollout by April 2026
ErlySign’s screening kit will be India’s first non‑invasive, saliva‑based diagnostic enabling oral cancer risk assessment with results classified as low, moderate, or high risk, empowering clinicians and individuals with actionable insights.
