Maharashtra gets US FDA approved HPV test for primary cervical cancer screening

AyuGen Biosciences announced the launch of Maharashtra’s state-of-the-art US FDA approved molecular diagnostics technology for primary cervical cancer screening.

This solution enables timely detection of risk of cervical cancer through Human papilloma Virus (HPV) DNA-based screening. It enables screening for the virus, even before the disease begins to manifest symptoms.

According to various published studies, cervical cancer is the second leading cause of cancer death for women in the state of Maharashtra, reports ~10 deaths due to cervical cancer per 1000001. In 2019 ~5,700 deaths were reported due to cervical cancer.

In India, cervical cancer is the second most common cancer in women (aged 15–44 years) after breast cancer accounting for almost 14 per cent of all women cancer. It is also one of the very few preventable cancers.

Due to insufficient accessible screening facilities, cervical cancer is detected late leading to high mortality rates. It is observed that screening programmes conducted every five years in several countries have been able to reduce the incidence and mortality related to cervical cancer by 60 per cent.

Manish Pungliya, Founder Director, AyuGen Biosciences, said, “Cervical cancer is the only cancer whose cause is known and it can be prevented. At AyuGen our mission is to provide women opportunity to prevent and fight this cancer early – by providing them with high-quality and affordable HPV testing. Cervical cancer eradication is major challenge for our nation and the world in today’s time. Our organisation has been working in this area of cervical cancer prevention for last eight years and we are proud to launch state’s first US FDA approved and clinically validated HPV DNA test. “Cervival” is the one-stop solution for Woman’s Health!”

“Cervical cancer is preventable, but yet not prevented in India. We must urge every gynecologist to do at least one screening per day preferably with HPV-DNA test for early diagnosis of cervical cancer. Cervical cancer is treatable and curable if detected in early stages,” said, Dr Harshad Parasnis, Consultant Gyn Oncologist, President Pune ObGyn Society 2020 – 2021.

WHO, aims to eradicate cervical cancer in 2030 and screen 70 per cent of the eligible women to achieve this target. Recently, WHO launched a Global Strategy to Accelerate the Elimination of Cervical Cancer outlining three key steps: vaccination, screening and treatment.

Successful implementation of all three could reduce more than 40 per cent of new cases of the disease and five million related deaths by 2050. The step to screening could be accomplished only by setting up of a scalable molecular HPV DNA test which is completely automated that will help in screening a huge population of eligible women.

The programme is aimed at providing access to primary HPV DNA test with genotyping from a dedicated center for testing at AyuGen Biosciences for 50000 women within next five years.

The HPV DNA test is the first US FDA approved test for cervical cancer screening, being clinically validated it is the most commonly used test in national screening programmes of several countries like Netherlands, Australia, Singapore, Malaysia to name a few. WHO aims to eradicate cervical cancer in 2030 and screen 70 per cent of the eligible women to achieve this target. A scalable molecular HPV DNA test which is completely automated will be suitable to achieve screening a huge population of eligible women.