Menstrual Blood-Based Self-Sampling Cervical Cancer Test Granted Patent in India

Ahmedabad: IOTA Diagnostic, a medtech startup backed by IIMA Ventures, has received an Indian Patent for its M-Strip™, an innovative cervical cancer screening test that uses menstrual blood as a biospecimen. This follows regulatory approval from the Central Drugs Standard Control Organization (CDSCO) and successful clinical validation.

Through a strategic partnership facilitated by IIMA Ventures, IOTA Diagnostic and Sterling Accuris Diagnostics collaboratively developed the M-Strip™ device—a CDSCO-approved and clinically validated self-sampling kit for cervical cancer (HPV) and STI screening. Sterling Accuris then leveraged its expertise as a go-to-market (GTM) partner to drive early market adoption, playing a pivotal role in supporting IOTA’s clinical validation, scaling efforts, and bringing the M-Strip™ to market.

Cervical cancer is the second most common cancer among women in India, causing around 80,000 deaths annually. Early detection is crucial, but traditional screening methods are invasive, uncomfortable, and often inaccessible, leading to low participation rates and late-stage diagnoses.

M-Strip™ provides a simple, non-invasive alternative, allowing women to collect menstrual blood using a sanitary pad-based device. The sample is stored and sent to a lab for analysis, eliminating painful procedures, reducing reliance on skilled professionals, and encouraging more women to undergo screening. Clinical validation has shown that 96% of users preferred M-Strip™ over traditional methods, with testing so far detecting a 9% incidence rate of high-risk HPV.

Vipul Patel, Partner, Seed Investments, IIMA Ventures said, “As the first institutional investor, we foster strategic connections—propelling breakthrough innovations toward scalable impact. We believe in supporting transformative solutions that drive real change. IOTA Diagnostic’s M-Strip™ is revolutionizing women’s healthcare by overcoming critical barriers in cervical cancer screening. With this patent, the company is poised to expand its reach and make a life-saving difference”

The World Health Organization (WHO) recommends regular HPV screening from age 30 using high-performance tests like PCR for early detection and prevention. However, conventional diagnostics such as microscopy and cytology, are not designed to detect HPV, but its later effects. Traditional methods are painful and rely on skilled professionals. Inappropriate sampling compromise accuracy, and leading to diagnoses at advanced stages. Globally, around 660,000 women are diagnosed with cervical cancer each year, with more than 350,000 deaths from this cancer.

Vaibhav Shitole, Founder, IOTA Diagnostic, said, “ We firmly believe that M-Strip™ will significantly increase cervical cancer screening participation by overcoming the major barriers of pain, discomfort, and privacy concerns that have historically hindered women from seeking regular tests. With the successful clinical validation, CDSCO approval, and now our secured patent, we are excited to scale this life-saving technology globally and reduce cervical cancer deaths.”

 

IOTA Diagnostic is committed to making this screening method affordable and accessible, particularly in underserved and remote areas. The company has also partnered with the Tata Institute for Genetics and Society (TIGS) to develop an Indigenous HPV PCR kit, further enhancing early detection capabilities.

Recently, M-Strip™ was recognized and awarded by Shri J. P. Nadda, the Honorable Health Minister of India, at the IIMA Healthcare Summit 2025. The innovation is the result of collaborative efforts by Vaibhav Shitole (Founder, IOTA Diagnostic), Rajiv Sharma (MD, Sterling Accuris Diagnostics), and Dr. Somesh Chandra (Senior Consultant Surgical Oncologist & Robotic Surgeon, KD Hospital, Ahmedabad).

With its patent secured, IOTA Diagnostic is set to transform cervical cancer screening, improving early detection and saving lives. The company is also developing new applications for diagnosing STDs and reproductive health issues in women using M-Strip™ self-sampling device.

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