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Nagpur-based biotech startup ErlySign has claimed to have developed India’s first saliva-based test for detecting oral precancerous conditions, delivering results in 15 minutes. This technology utilises biomarkers (MMP2 and MMP9), offering a non-invasive solution for early cancer detection.
The test, leveraging biomarkers, claims 98.04 per cent sensitivity and 100 per cent specificity, indicating high accuracy. ErlySign recently secured Rs 16 crore in pre-Series A funding, led by investor Ashish Kacholia. These funds will enable the startup to finalise clinical trials, secure approvals from the Central Drugs Standard Control Organisation (CDSCO), and bring its product to market. The company anticipates completing trials and obtaining regulatory clearance by Q2 2026.
Speaking about the test, Shubhendra Singh Thakur, founder of ErlySign, stated, "Our test targets specific salivary biomarkers, MMP2 and MMP9, which are highly indicative of oral cancer progression. This non-invasive and affordable test aims to significantly improve early detection rates, reduce the burden of oral cancer in India, and ultimately save lives. We are confident that this technology has the potential to revolutionise oral cancer diagnostics."
Thakur also shared that initial studies, conducted with 150 samples in collaboration with the Government Dental College in Nagpur, yielded positive results. The test categorises patients into three risk levels: low (healthy), moderate (early cancer progression without visible lesions), and high (presence of tumours or lesions requiring further diagnostics).
Doctors see promise but say test needs more validation
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Speaking about the credibility of the test, Dr Ajesh Raj Saksena, senior consultant surgical oncologist at Apollo Hospital, Hyderabad, stated, "It would be very useful to have an objective, non-invasive test for screening to detect precancerous lesions. However, the current sample size might be too limited to validate its use on a large scale. Screening tests generally require extensive validations to arrive at reliable conclusions."
Meanwhile, Dr Sachin Trivedi, director of medical oncology at HCG Cancer Centre, Colaba, stated, "While the results from the test so far are promising, clinical trials are essential to validate its effectiveness in real-world scenarios. Peer-reviewed publications will further establish its credibility."
“For individuals at high risk, like tobacco or marijuana users, I would recommend this test at least once a year to detect oral cancer early," Trivedi added.
With an estimated 1.5 lakh cases of oral cancer diagnosed annually in India and a high mortality rate due to late detection, ErlySign claims that its test has the potential to reduce the healthcare burden.
The non-invasive cancer diagnostics market is projected to reach $250 billion by 2030. In India, the oral cancer diagnostics market alone is valued at $2.98 billion, growing at a compound annual growth rate (CAGR) of 4.8 per cent.
Looking ahead, ErlySign is also developing a CRISPR (clustered regularly interspaced short palindromic repeats) miRNA-based technology to expand its capabilities, enabling the detection of multiple cancers—including lung, breast, pancreatic, and colorectal cancers—using a single saliva sample. This advanced diagnostic device aims to provide information on cancer type, stage, malignancy, and progression rate, transforming the test from a screening tool to a comprehensive diagnostic solution.
Founded in 2018, ErlySign initially raised an angel round of Rs 15 lakh in 2019 to set up its research lab in Nagpur. The company secured an additional Rs 1.47 crore in 2021 for product development and trials and received a Rs 20 lakh grant from the Department of Science and Technology. The latest funding will be used to finalise trials, scale production, and validate the CRISPR miRNA product.
To ensure widespread accessibility, ErlySign is forging partnerships with oncology chains like Healthcare Global (HCG), which operates 29 centres across India. The company also plans to collaborate with government healthcare initiatives and corporate social responsibility (CSR) activities to reach rural and underserved populations.
While the initial focus remains on the Indian market, ErlySign has set its sights on global expansion. The company plans to pursue a 510(k) notification for expedited US FDA approval by December 2025.
