California based POC Medical System will launch the test 'MammoAlert' in India by July this year enabling women across the country to be screened safely at affordable cost with high accuracy and with minimal false positives. With this launch, India will become first country in the world to have next generation portable, blood based screening test for early breast cancer detection.
The company will shortly apply for CE Mark approval of MammoAlert and is expected to receive the approval within six weeks. Following this, the test will be launched in India. Besides this, it is also planning to apply for US FDA approval which takes 9 months. Its easier and cost effective for one to go for MammoAlert to make sure that she does not have breast cancer rather than opting for time consuming and costly mammography for the same. If the test results are positive, one should go for confirmatory test like mammography.
Currently the company is in talks with all stakeholders in India including distribution partners, diagnostic chains, corporate hospitals and governments to introduce the breast cancer screening test.
It has talked to governments of Maharashtra and Gujarat to launch MammoAlert at public health facilities. Maharashtra health ministry has shown interest in conducting pilot project to make sure that women at grassroots level can be screened for breast cancer. “We will introduce the test to communities across the state so that more people can be benefited,” said health minister Dr Deepak Sawant.
The Gujarat government is also planning to introduce MammoAlert at public health facilities. When contacted JP Gupta, Principal Secretary (Public Health & Family Welfare) & Commissioner (Health) said “The company has discussed the project with us but we have not yet taken final call on it.”
POC Medical System is also talking to other state governments and major diagnostic chains and private hospitals for the same.
In India the number of new breast cancer cases estimated at 1.5 lakh (over 10 per cent of all cancers) during 2016.
MammoAlert helps ensure early diagnosis of breast cancer and prompt treatment that can reduce cancer death, said Sanjeev Saxena, chairman and CEO of POC Medical System.
Once the MammoAlert is launched, it will be expanded to screen other diseases affecting women, said Saxena. “Our aim is to save lives by addressing the dire need for creating medical diagnostics technology platform for screening cancer, cardiac and infectious diseases, that is reliable, portable and accessible to every person living, even in the remotest corners of the world at a very low cost,” he added.
POC Medical System has licensed MammoAlert from Lawrence Livermore National Labs, Sandia National Labs. Around US$ 150 million have been spent on development of the next generation screening test. POC has spent US$ 7 million on product commercialization, said Saxena.
The company had raised $21 million in Series A funding a couple of months back to commercialize the test.
This round was led by BioVentures Investors with participation from Sirius America Insurance Company, IFG Healthcare and MIA Investment Limited.
MammoAlert, based on Pandora Cdx microfluidics-based platform is small battery operated portable device with advanced electronics. It requires a drop of blood from a finger prick and no need to disrobe and expose to radiation. Its easy to use and does not require a doctor or skilled technicians to operate. The test employs a mobile device like a tablet that stores the data securely in the cloud, where it can then be shared remotely with doctors and healthcare systems. The test detects cancer biomarkers from a drop of blood using advanced CD microfluidics based on a low cost microfluidic disk and then applies sophisticated algorithms to produce a result. It screens 10 patients in less than 15 minutes at one go. Its highly sensitive and accurate. Cost of equipment and cost per test significantly lower making access a reality, said Ramana Tadepalli, Board Director - POC Medical Systems.