Indian biotech ErlySign has received US FDA Breakthrough Device Designation for its saliva-based oral cancer detection test, enabling accelerated regulatory review and development.
An Indian biotech startup has reached a significant regulatory milestone in the fight against oral cancer.
ErlySign, based in Nagpur, has been granted Breakthrough Device Designation by the US Food and Drug Administration for its saliva-based oral cancer early detection kit. The designation is awarded to medical devices that show potential to provide more effective diagnosis or treatment for life-threatening conditions.
The recognition places ErlySign among a limited group of healthtech innovators receiving accelerated regulatory support from the FDA.
What the designation means
The Breakthrough Device program is designed to expedite development and review processes for qualifying medical technologies. Devices under the program benefit from prioritized regulatory engagement, interactive guidance with the FDA, and potential flexibility in clinical evidence requirements.
For ErlySign, this status could significantly shorten timelines toward US market entry, while strengthening its credibility with global healthcare systems and payers.
CEO and Founder Shubhendra Singh Thakur described the designation as a “pivotal milestone,” emphasizing its role in accelerating patient access to non-invasive cancer detection tools.
A non-invasive approach to early detection
ErlySign’s test requires only a 2–5 ml saliva sample and delivers results within 10–15 minutes. The company says the diagnostic kit is designed to identify precancerous changes before visible tumors or lesions appear in the oral cavity, lips, tongue, throat, or larynx.
Early-stage detection remains one of the largest unmet needs in oncology. Many oral cancer cases are diagnosed only after symptoms become pronounced, reducing survival rates and increasing treatment complexity.
By eliminating the need for invasive biopsies in early screening stages, saliva-based diagnostics aim to lower barriers to testing.
Clinical validation and data
The company conducted multi-city clinical trials in collaboration with Healthcare Global Ltd. (HCG) and the Regional Cancer Hospital in Nagpur. According to ErlySign, trials involving approximately 1,000 patients across Nagpur, Bengaluru, and Ranchi demonstrated 98% sensitivity and 100% specificity.
Such metrics, if sustained through further validation and regulatory review, could position the test as a viable large-scale screening tool.
Chief Scientific Officer Dr. Deovrat Begde noted that detecting precancerous changes via saliva has historically been challenging in oncology, adding that the FDA designation validates the company’s biomarker-driven approach.
Addressing India’s oral cancer burden
India accounts for one of the highest global burdens of oral cancer, with over 143,000 new cases annually and nearly 80,000 deaths. Tobacco use, including smokeless forms, remains a major risk factor.
Despite the prevalence, early screening access remains limited, particularly in underserved regions.
A rapid, non-invasive, and potentially cost-effective saliva test could support integration into routine checkups, community health programs, and workplace screenings.
Commercial and global implications
Breakthrough designation does not constitute full FDA approval. However, it strengthens ErlySign’s regulatory pathway and enhances its positioning in international markets.
The company is exploring partnerships with healthcare providers and public health stakeholders to expand pilot programs and screening initiatives.
For Indian biotech startups, global regulatory recognition represents a critical validation step — both scientifically and commercially.
The broader shift toward non-invasive diagnostics
The designation reflects a larger healthcare trend toward minimally invasive and point-of-care testing.
Advances in biomarker science and molecular diagnostics are reshaping early detection strategies across oncology.
If scalable and affordable, saliva-based diagnostics could complement imaging and biopsy workflows, particularly in high-risk populations.
ErlySign’s milestone underscores how innovation emerging from India’s biotech ecosystem is increasingly intersecting with global regulatory frameworks.
The next phase will depend on continued clinical validation, regulatory clearance, and real-world deployment.
But for early cancer detection — where time often defines survival — accelerating innovation could carry life-saving implications.
