ErlySign granted US FDA breakthrough device designation for its saliva-based oral cancer detection test

New Delhi: ErlySign, the innovative biotech company from Nagpur that is transforming early cancer detection with non-invasive diagnostics, has been granted the US Food and Drug Administration (FDA) Breakthrough Device Designation for its saliva-based oral cancer early detection kit.

The designation marks a significant global regulatory milestone for the company and underscores the potential of its technology to advance early cancer detection across international markets. 

The FDA Breakthrough Device Designation is awarded to medical devices that demonstrate reasonable clinical evidence of providing more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. Devices under this program benefit from accelerated development, prioritised regulatory review, and enhanced interaction with the FDA, enabling faster patient access to innovative medical technologies.

Commenting on the milestone, Shubhendra Singh Thakur, CEO & Founder of ErlySign, said, “Receiving the US FDA Breakthrough Device Designation is a pivotal milestone for ErlySign. Beyond recognition, this designation enables priority regulatory review, closer and more interactive engagement with the FDA, and greater flexibility in clinical evidence requirements, significantly accelerating our path to market. It also strengthens our ability to engage with global healthcare systems and payers, helping ensure that a truly non-invasive, early cancer detection solution reaches patients faster, where it is needed most.”

ErlySign’s oral cancer detection test is India’s first saliva-based, non-invasive diagnostic solution designed to identify precancerous conditions even before visible tumours or lesions appear in the oral cavity, lips, tongue, throat, or larynx. The test requires only a 2–5 ml saliva sample and delivers results within 10–15 minutes, making it quick, painless, and easy to deploy across diverse healthcare settings.

The technology has been clinically validated through large-scale, multi-city trials conducted in collaboration with Healthcare Global Ltd. (HCG) and the Regional Cancer Hospital (Rashtrasant Tukdoji Cancer Hospital), Nagpur. The studies, conducted across approximately 1,000 patients in Nagpur, Bengaluru, and Ranchi, demonstrated 98% sensitivity and 100% specificity, validating the test’s accuracy and effectiveness.

From a scientific and clinical standpoint, the Breakthrough Device Designation validates the robustness of our biomarker-driven approach and the depth of our clinical evidence. Detecting precancerous changes in a simple saliva sample before visible symptoms appear has long been a challenge in oncology. This recognition reinforces our belief that precision biology combined with non-invasive diagnostics can fundamentally change how cancers are detected, monitored, and managed globally,” said  Dr Deovrat Begde, CSO & Co-founder, ErlySign.

India bears one of the world’s highest burdens of oral cancer, with mouth cancer being the second most common malignancy in the country, accounting for over 143,000 new cases and nearly 80,000 deaths annually. Despite this, early detection remains a major challenge, with many cases diagnosed at advanced stages due to limited access to screening. The cost-effectiveness of ErlySign’s saliva-based test could support integrating early oral cancer screening into routine care, particularly for underserved and high-risk populations.

With the US FDA Breakthrough Device Designation, ErlySign strengthens its position in advancing early, non-invasive cancer detection and is actively exploring partnerships with healthcare providers and public health stakeholders to enable broader screening programs and pilot deployments globally.