ErlySign Receives US FDA Breakthrough Device Designation for Saliva-Based Oral Cancer Test

The company’s diagnostic kit is designed to detect precancerous changes before visible tumors or lesions develop in the oral cavity, including the lips, tongue, throat, and larynx.

ErlySign, a Nagpur-based biotechnology startup, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its saliva-based oral cancer early detection test. The designation is granted to medical devices that show potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.

The company’s diagnostic kit is designed to detect precancerous changes before visible tumors or lesions develop in the oral cavity, including the lips, tongue, throat, and larynx. The test requires a 2–5 ml saliva sample and delivers results within 10–15 minutes.

According to the FDA, the Breakthrough Device Designation program is intended to accelerate the development and review of technologies that address unmet medical needs. The recognition enables closer regulatory interaction and priority review processes.

ErlySign states that its solution is India’s first saliva-based, non-invasive diagnostic test aimed at identifying early-stage oral cancer risk through a rapid screening approach. The test is designed for use across varied healthcare settings, including clinics and community screening programs.

Clinical validation of the technology was conducted through multi-city trials in collaboration with Healthcare Global (HCG) and the Regional Cancer Hospital (Rashtrasant Tukdoji Cancer Hospital) in Nagpur. The studies involved approximately 1,000 patients across Nagpur, Bengaluru, and Ranchi.

Trial data showed 98% sensitivity and 100% specificity in detecting relevant markers associated with oral cancer risk, according to the company. Sensitivity measures the test’s ability to correctly identify patients with the condition, while specificity reflects its ability to correctly identify those without it.

Oral cancer remains a significant public health concern, particularly in India, where late-stage diagnosis is common. Early detection tools are considered critical in improving treatment outcomes and survival rates.

With the FDA Breakthrough Device Designation, ErlySign moves into the next phase of regulatory engagement in the United States as it advances development and commercialization plans for its oral cancer detection platform.

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