IOTA Diagnostic’s M-Strip transforms cervical cancer screening

Med-Tech startup secures CDSCO approval for at-home self-sampling using menstrual blood, marks milestone in women's health technology

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New Delhi: IOTA Diagnostic has announced approval for its innovative M-Strip device by the Central Drugs Standard Control Organization (CDSCO) in India.
The M-Strip represents a major advancement in cervical cancer screening, allowing women to self-collect samples at home using menstrual blood, thus offering unprecedented privacy and convenience.
The M-Strip’s technology revolutionizes the detection of Human Papillomavirus (HPV) and other infectious diseases by enabling easy and private sample collection at home. This method for cervical cancer screening was conceptualized by Dr. Somesh Chandra and developed in collaboration with Sterling Accuris. The approval marks a crucial step in making cervical cancer screening more accessible and encouraging wider participation in screening programs.
Vaibhav Shitole, founder of IOTA Diagnostic, alongside Dr. Somesh Chandra, a renowned oncologist from Ahmedabad, and Rajiv Sharma from Sterling Accuris, are the inventors and co-filers of the patent for the M-Strip device. Recently, the Indian Patent Office granted a design patent for the device.
Commenting on this achievement, Shitole stated, “The CDSCO’s approval of M-Strip marks a major milestone for IOTA Diagnostic and represents a significant leap forward in the field of women’s health, particularly in the early detection and screening of cervical cancer and STIs. This technology introduces dual innovations. Firstly, in the diagnostic method, M-Strip leverages the distinctive properties of menstrual blood and benefits from Dried Matrix, through our proprietary material, allowing sample collection and preservation for extended durations for the diagnostic tests. Secondly, innovation extends to the device’s design, facilitating self-sampling in women’s comfort zones and enabling hassle-free shipment without the need for cold environments and transportation media. As a result, this novel approach significantly reduces diagnostic costs for patients in remote locations and even in urban areas, while eliminating the need for sample collection by skilled medical professionals and expensive clinical setups.”
Cervical cancer is the second most common cancer among women aged 15-44 in India, with 123,907 new cases and 77,348 deaths annually. Despite this, only 2% of Indian women undergo cervical cancer screenings. HPV prevalence is alarming, with 88-97% of women with cervical cancer and 10-37% without gynaecological issues carrying the virus.
Current screening methods, such as Pap smears, visual inspections, and DNA tests, lack sensitivity in early detection and rely on invasive procedures. Societal taboos further deter women from seeking routine screenings, increasing cancer risk.
The WHO recommends regular screenings for women aged 25-65, but resource constraints in India necessitate alternatives like lifetime screenings using high-performance HPV DNA tests. Delayed diagnosis often leads to advanced-stage disease, resulting in costly treatments and higher mortality rates.
The M-Strip revolutionizes cervical cancer screening by enabling easy self-sampling and aligning with WHO’s recommendation of HPV-DNA testing. This non-invasive method facilitates the collection, storage, and transportation of dried menstrual blood, promoting early detection and reducing mortality rates, especially in underserved rural areas.
This milestone follows the launch of IOTA Diagnostic’s patented IOTA BioSampler at Global Bio-India 2023, recognized by Gujarat’s Chief Minister, Bhupendrabhai Patel. Supported by BIRAC-DBT, Sristi Innovations, i-Hub Gujarat, and STBI-Vadodara, the M-Strip aims to enhance accessibility to cervical cancer screening for women in India and underserved regions through a cost-effective approach.