Novel Blood Test for Breast Cancer Detection : Pan India Clinical Trial begins

Dr Raghu Ram appointed Principal Investigator - Pan India multi centre Breast cancer Screening trial using disruptive technology 'MammoAlert™'– a rapid, low cost, accurate blood test'.

Hyderabad – POC Medical Systems Inc based out of California, which has innovated 'MammoAlert™'System - World's first disruptive screening technology for breast cancer and Ushalakshmi Breast Cancer Foundation, a not for profit Breast cancer Charity based out of Hyderabad has announced collaboration to launch pan India multi centre breast cancer screening trial based upon disruptive technology 'MammoAlert™'– a rapid, low cost, accurate blood test'.

Dr. P. Raghu Ram, CEO Ushalakshmi Breast Cancer Foundation & Director, KIMS-USHALAKSHMI Centre for Breast Diseases will be spearheading this Clinical Trial as Pan India Principal Investigator. The study design involves looking at activity of panel of four Breast cancer specific biomarkers in a blood sample collected from women presenting with newly diagnosed breast cancers to seven Cancer Centres spread across India. KIMS-Hospitals & Indo American Cancer Centre from Hyderabad, Manipal Hospitals (Bengaluru), Tata Medical Centre (Kolkata), Maulana Azad Medical College (New Delhi), Amrita Institute of Medical Sciences (Kochi) & HCG Cancer Centre (Ahmedabad)would be participating in this landmark Study to assess the accuracy of this blood test.

Since beginning of June 2017, more than 100 patients have already been recruited in this trial. The clinical study will help POC Medical Systems Inc. to revalidate the technology in Indian patients and get accurate India centric data. This data excercise would also be a stepping stone towards designing & implementing a population based Breast Cancer Screening programme in the rural areas all across India in collaboration with Ushalakshmi Breast Cancer Foundation.

Delivering the Chief Guest's Address, Ms Lakshmi Manchu, Actor, Producer & Television host said "I congratulate Dr. Raghu Ram for his missionary zeal & consistent innovative initiatives over the past ten years towards improving Breast cancer care in India. I am delighted that he is collaborating with POC Medical Systems Inc in conducting a pan India clinical trial to assess the accuracy of this disruptive diagnostic breast cancer Screening tool. Dr Raghu Ram has always been a pioneer in bringing the best of technology and has been on the forefront in providing medical assistance, especially to those in rural areas who do not have much access to diagnostic tests and state of the art treatment facilities. I am so happy to learn that with the help of 'MammoAlert™'System, detection of something as concerning & as common as Breast cancer can be done through a simple blood test. I wish Dr. Raghu Ram and the team associated with POC Medical Systems all the very best."

Mr Sanjeev Saxena, Managing Director, POC Medical Systems Inc, California, USA said, "We are very excited to collaborate with Ushalakshmi Breast Cancer Foundation as our vision is same, i.e. 'Early detection of Breast Cancer'. This collaboration would help spread the message about importance of early detection and offer a simple cost effective reliable Screening tool in the form of a blood test to underprivileged women living in rural India."

While speaking at the Press Conference, Mr Ramana Tadepalli, Board Director, POC Medical Systems Inc. mentioned, "It's a very proud moment as we have recently received theCE Certification (legal designation that the manufacturer's product has met the requirements of all relevant Medical Device Directives in the European Union). We are delighted that Dr. Raghu Ram, one of the foremost Breast Surgeons from South Asia is the Principal Investigator (PI) spearheading the Multi Centre Pan India Clinical trial to assess the accuracy of 'MammoAlert™'– a rapid, low cost, accurate blood test to detect early breast cancer. We are confident of achieving our end goals i.e. 'erasing fear of cancer', as early detection ensures better cure rates".

Dr. P. Raghu Ram, Padma Shri awardee, CEO/Director, Ushalakshmi Breast Cancer Foundation based out of Hyderabad said, "Over the past decade (2007 -2017), the Foundation has been working with missionary zeal empowering people in Telangana & Andhra Pradesh about the importance of early detection of breast cancer through a number of unique & innovative initiatives in addition to implementing South Asia's largest population based Breast Cancer Screening Programme reaching out to some 200, 000 underprivileged women spread across 4000 villages in Telangana & Andhra Pradesh. The Foundation's vision for the next ten years is to replicate the impact created in the Telugu States all across the Country. We are very happy to associate with POC Medical Systems and its flagship product 'MammoAlert™.' In the fullness of time, I am very hopeful that this technology would not only revolutionize Breast Cancer Screening in India and the world over, but will also help in enhancing the access and accuracy in cancer detection, especially in rural population, thus saving more lives."

Although introduction of population-based breast screening programme using mammography is the best proven way of detecting early breast cancer, it is not a viable option for mass screening in India owing to the enormous costs involved. According to World Health Organisation (WHO) statistics, less than 5% of women in India undergo screening Mammography. Furthermore, with breast cancer being a 'closet issue' - a 'taboo' in most parts of the Country, more than 60% of breast cancers present in advanced stages with poor survival. Exposing oneself to get tested for Breast Cancer is one of the biggest deterrents in India apart from high cost of Mammography. With 'MammoAlert', women can now get screened with the help of a simple blood test.

This portable breast cancer screening test, uses a simple drop of blood to generate results in 15 minutes. It does not require expensive equipment or expertise to generate the result. In the Studies done thus far, the MammoAlert™' has demonstrated an accuracy of over 95% and a false positive rate of zero. This disruptive technology will hopefully have a huge social impact enabling thousands of women in India to detect breast cancer in its early stage as this test is simple, low cost and accurate.

With over 150, 000 new cases being diagnosed annually, the incidence of Breast cancer has overtaken Cervical cancer to become the most common cancer affecting women in India. This is only the tip of the iceberg, as many breast cancers are not reported to the Cancer Registry & many States in the Country do not have a robust Cancer Registry. In a striking contrast to the West where most breast cancers are diagnosed over the age of 50, the vast majority of Breast cancers in India are diagnosed in younger women between the ages of 25-50. Due to lack of awareness and absence of an organised nationwide population based Breast Cancer Screening Programme, more than 60% present in the advanced stages. A woman succumbs to breast cancer every ten minutes in India.