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Pathbreaking Innovation: A Med-Tech Startup Developed a Novel Approach for Cervical Cancer Screening, Secures CDSCO Approval in India

 IOTA Diagnostic, a pioneering med-tech startup in bio-sampling solutions, proudly announces a significant milestone with the recent approval of its groundbreaking M-Strip device by the Central Drugs Standard Control Organization (CDSCO) in India. The M-Strip, is an indigenously built novel advancement for cervical cancer screening which empowers women to mark themselves safe by self-sampling in the comforts and privacy of their homes. This revolutionary method for cervical cancer screening using menstrual blood, follows a study conceptualized by Dr Somesh Chandra, the principal investigator, which was carried out in collaboration with Sterling Accuris, a leading diagnostic chain in northwest India. This truly marks a step towards taking cervical cancer screening to the beneficiaries’ doorstep and opening the window towards wider participation in screening programs to control cervical cancer.

Mr Vaibhav Shitole, the founder of IOTA Diagnostic, alongside Dr. Somesh Chandra, a renowned Oncologist from Ahmedabad and Mr. Rajiv Sharma from Sterling Accuris are the inventors and Co-Filers of the patent for the M-Strip device. Recently, the company was granted a design patent for the device by the Indian Patent Office.

Commenting on this landmark initiative, Mr. Vaibhav Shitole, Founder of IOTA Diagnostic 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.

The M-Strip, an innovative technology based on a dried blood cell matrix, signifies a monumental leap forward in bio-sampling solutions for women health. By harnessing the power of menstrual fluid, the M-Strip empowers women with unparalleled privacy and addresses entrenched societal taboos, revolutionizing the easy detection of Human Papillomavirus (HPV) and other infectious diseases in the comfort at their home.

The current methods for cervical cancer screening include Pap Smear Microscopy, Visual Inspection and DNA tests. However, conventional screening techniques like pap smears and cytology often lack sensitivity in detecting diseases at initial stages. Further, most diagnosis predominantly rely on cervical swab collection by skilled medical professionals in hospital settings. This process is often uncomfortable, painful, and inconvenient for women, leading many to avoid routine screenings. Societal taboos further deter women from seeking cervical cancer screenings. Thereby inadvertently increasing the risk of cervical cancer development over time. M-Strip integrated into the sanitary pads offer a non-invasive alternative during menstruation, allowing for sample collection without discomfort and send them for laboratory analysis.

In a country where only 2% of women have undergone cervical cancer screenings, the statistics surrounding HPV prevalence paint a stark picture. Among women with cervical cancer, HPV rates soar to a staggering 88-97%, while among women without gynecological morbidities, HPV prevalence ranges from 10-37%. With 123,907 new cases and 77,348 deaths reported annually, cervical cancer is the second most common cancer among women aged 15-44 years in India.

The World Health Organization (WHO) advocates for regular screening among women aged 25-65 years to detect precancerous lesions. However, resource constraints in countries like India have necessitated alternative approaches, such as at least two lifetime screenings using high-performance HPV DNA test after the age of 30, with a screenings interval of 10 years. Delayed diagnosis often leads to advanced stage disease, resulting in expensive treatments, poor prognosis, and ultimately higher mortality rates.

M-Strip significantly advances cervical cancer screening in two key ways. Firstly, it facilitates easy, convenient, and self-empowered sample collection. Secondly, it aligns with WHO’s recommendation by utilizing HPV-DNA testing as the primary and preferred screening method. Designed for the non-invasive collection, storage, and transportation of dried menstrual blood for laboratory analysis it also conforms to the idea of self-sampling which was recently approved by US FDA. By prioritizing privacy, convenience, and non-invasiveness, it encourages early screening, facilitating early detection and reducing mortality rates due to the disesease, especially in underserved rural areas with limited healthcare access.

This milestone achievement follows the successful launch of IOTA Diagnostic’s central patented technology, the IOTA BioSampler, at Global Bio-India 2023. The device received further recognition when it was unveiled by the Chief Minister of Gujarat, Shri Bhupendrabhai Patel, at the pre-Vibrant Biotechnology Summit in Gujarat. Supported by BIRAC-DBT, Sristi Innovations, Entrepreneurship Development Institute of India, i-Hub Gujarat, and STBI- Vadodara, IOTA DIAGNOSTIC anticipates that the M-Strip will enhance accessibility for women in India and underserved regions through a cost-effective approach for cervical cancer screening.

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