IOTA Diagnostic, a MedTech startup, has received an Indian patent for its revolutionary M-Strip device—a self-sampling kit for cervical cancer screening using menstrual blood as a biospecimen. The non-invasive, CDSCO-approved device promises to transform HPV and STI screening, particularly among women in resource-poor areas.

Key Highlights

Patent and Regulatory Approval Obtained

• IOTA Diagnostic was granted an Indian patent for the M-Strip menstrual blood-based test.

• The product is CDSCO-approved and clinically tested for cervical cancer (HPV) and STI screening.

New Screening Technique Developed

• M-Strip enables females to collect menstrual blood through a sanitary pad-based device that can be sent for laboratory testing.

• It provides a non-invasive, self-sampling option as compared to conventional screening tests.

Excellent User Preference and Clinical Success

• 96% of the users showed preference for M-Strip over conventional screening tests.

• The test identified a 9% prevalence rate of high-risk HPV in clinical trials.

Strategic Partnerships Enhance Market Penetration

• Co-developed with Sterling Accuris Diagnostics under the aid of IIMA Ventures.

• Sterling Accuris contributed to clinical validation, scaling, and early acceptance.

• Partnership with Tata Institute for Genetics and Society (TIGS) in progress to co-create an Indigenous HPV PCR kit.

Overcoming a Significant Public Health Problem

• Cervical cancer is the second most prevalent cancer among Indian women and results in almost 80,000 deaths each year.

• Regular HPV PCR-based screening is what WHO advises for early detection—something M-Strip is working to streamline and make accessible to more.

Quotes from Leaders or Officials
Vaibhav Shitole, Founder, IOTA Diagnostic
"With M-Strip, we are not merely building a product, but a movement to make life-saving diagnostics accessible to every woman, even at the remotest locations."Rajiv Sharma, MD, Sterling Accuris Diagnostics
"This innovation is a significant change in women's healthcare—making diagnostics more accessible, less invasive, and more widely adopted."With its emphasis on affordability, comfort, and accessibility, M-Strip is set to revolutionize the detection and management of cervical cancer in India. Its recent award at the IIMA Healthcare Summit by Health Minister J.P. Nadda further emphasizes its national significance.