In a groundbreaking development in the field of cancer diagnostics, Nagpur-based biotech startup ErlySign has introduced India’s first saliva-based test for detecting oral precancerous conditions. The innovative test delivers results in just 15 minutes and leverages biomarkers MMP2 and MMP9 to offer a highly accurate, non-invasive solution for early cancer detection.
Revolutionizing Early Detection with Biomarkers
The saliva test’s remarkable sensitivity (98.04%) and specificity (100%) highlight its potential to transform oral cancer diagnostics. Biomarkers MMP2 and MMP9 are critical indicators of oral cancer progression, making this test an invaluable tool for early detection. According to ErlySign, this innovation aims to significantly reduce the healthcare burden of oral cancer, which is diagnosed in an estimated 1.5 lakh individuals annually in India. Late detection often leads to high mortality rates, a challenge ErlySign’s test seeks to address effectively.
Founder Shubhendra Singh Thakur elaborated, “Our test targets specific salivary biomarkers that indicate early stages of oral cancer. By providing a non-invasive and affordable solution, we aim to improve early detection rates and save countless lives. We believe this technology has the potential to revolutionize oral cancer diagnostics.”
Funding to Drive Clinical Trials and Market Launch
To bring this technology to the market, ErlySign recently secured ₹16 crore in pre-Series A funding, led by prominent investor Ashish Kacholia. The funding will be instrumental in finalizing clinical trials, obtaining approvals from the Central Drugs Standard Control Organisation (CDSCO), and scaling up production. The company anticipates completing clinical trials and securing regulatory clearance by the second quarter of 2026.
Encouraging Initial Results from Pilot Studies
The startup’s pilot studies, conducted in collaboration with the Government Dental College in Nagpur, involved 150 samples and yielded promising results. The test categorizes patients into three risk levels:
- Low Risk: Individuals with no visible signs of precancerous conditions.
- Moderate Risk: Early cancer progression without visible lesions.
- High Risk: Presence of tumors or lesions requiring further diagnostics.
Senior consultant surgical oncologist Dr. Ajesh Raj Saksena from Apollo Hospital, Hyderabad, commented on the innovation’s potential: “It would be very useful to have an objective, non-invasive test for screening precancerous lesions. However, extensive validations and larger sample sizes are necessary to establish its reliability.”
Expert Opinions and Validation Requirements
While the initial findings are promising, oncologists emphasize the need for further validation. Dr. Sachin Trivedi, director of medical oncology at HCG Cancer Centre in Colaba, remarked, “Clinical trials are essential to validate its effectiveness in real-world scenarios. Peer-reviewed publications will be crucial to establishing credibility.” For individuals at high risk, such as tobacco or marijuana users, Trivedi recommends undergoing the test annually to ensure early detection. This preventive measure could significantly reduce the high mortality rate associated with oral cancer in India.
Market Potential and Future Expansion
The non-invasive cancer diagnostics market is expected to reach a staggering $250 billion by 2030, with India’s oral cancer diagnostics segment alone valued at $2.98 billion, growing at a CAGR of 4.8%. ErlySign’s test is poised to make a significant impact in this burgeoning market. In addition to its current offering, ErlySign is developing a CRISPR miRNA-based technology to detect multiple cancers, including lung, breast, pancreatic, and colorectal cancers, using a single saliva sample. This advanced diagnostic device will provide detailed insights into cancer type, stage, malignancy, and progression rate, elevating it from a mere screening tool to a comprehensive diagnostic solution.
Funding and Strategic Partnerships
Founded in 2018, ErlySign’s journey began with an angel investment of ₹15 lakh in 2019 to establish a research lab in Nagpur. The startup raised an additional ₹1.47 crore in 2021 for product development and trials, along with a ₹20 lakh grant from the Department of Science and Technology. The latest funding round will enable the company to finalize trials, scale production, and validate its CRISPR miRNA-based product. To ensure accessibility, ErlySign is forging partnerships with leading oncology chains such as Healthcare Global (HCG), which operates 29 centers across India. Collaborations with government healthcare initiatives and corporate social responsibility (CSR) programs aim to reach underserved rural populations, where access to diagnostics remains limited.
While the initial focus is on the Indian market, ErlySign has ambitious plans for global expansion. The company aims to secure a 510(k) notification for expedited US FDA approval by December 2025, paving the way for its entry into international markets. ErlySign’s saliva-based test represents a monumental leap in oral cancer diagnostics, offering a non-invasive, rapid, and accurate solution to address a significant healthcare challenge. Backed by robust funding and strategic partnerships, the startup is well-positioned to revolutionize cancer diagnostics in India and beyond. With its vision of early detection and comprehensive diagnostics, ErlySign is not only addressing the healthcare burden but also setting the stage for a healthier future.
