Dr Sanjeev Saxena, Founder and CEO, POC Medical Systems in an interaction with Viveka Roychowdhury, gives information about low cost tests to screen various cancers, which will be launched in the Indian market shortly
Point-of-care testing (POCT) is very common in management of blood glucose levels as part of diabetes care. What are the other disease conditions that are now being or could be managed with such diagnostic platforms?
We are currently focussing on launching ‘MammoAlert’ for breast cancer screening. However, going ahead, we expect to develop such early screening and low-cost tests for other cancers like prostate, ovarian, cervical, lung, liver etc.
Further, we also expect to develop tests for cardiac screening and infectious diseases like TB, typhoid, dengue, STDs, ebola etc.
What is the science behind POC Medical Systems’ MammoAlert and the Pandora CDx microfluidics-based platform?
The Pandora CDx developed by POC Medical Systems is a microfluidic platform for rapid, point-of-care serum testing. It is based on a unique, low cost disposable microfluidic disk. The platform is very simple and easy-to-use system.
MammoAlert is the first product based on this technology. This portable breast cancer screening test, which runs on Pandora CDx technology, uses a few drops of blood from a finger prick to generate results in 20 minutes. It uses multiple cancer markers for high accuracy.
An instrument which is the size of a CD player:
- A microfluidics disk, where the reaction takes place between the blood and the reagents
- The chemistry which consists of various reagents already prepared and loaded on the disk, so no human interaction is required in the field except for loading of blood
- The software which records and analyses the data that can be accessible from any location to a doctor and a report automatically post the test.
So, the instrument which is called the Pandora CDx (runs on rechargeable batteries) that can be taken to any village or in any neighbourhood or can be run in any lab or doctor’s office with minimal training.
The way it works is as follows:
- The technician or operator enters patient’s information on a tablet
- Pricks the patients finger with a lancet
- Applies the blood to the inlet in the disc where the blood has to be inserted
- Selects the test and presses ‘Enter’
- The test is then performed on its own and the results are displayed and displayed/ printed within 20 minutes. The disk is then removed from the Pandora CDx and disposed
- All the results are maintained on cloud for further research and reference
So, you have microfluidic channels where you have the antibodies already conjugated on beads and pre-loaded into these micro channels. When we put in a drop of blood, it attaches to that and incubates very quickly because we are dealing with very small samples. It then migrates to another chamber which has a separation median so that the HPLC equivalent is done right there. Because the disk is spinning at a high rpm, the separation takes place right there and blood cells get separated out. At the end of the chamber, you have detection of the fluorescence. Everything that you are doing outside, you are doing in this little disk itself. That is why you are able to automate the whole process, and you do not need any trained personnel to do it.
How can POCT as a diagnostic domain, be applied in a viable and sustainable manner, to improve public health, especially in resource poor countries like India where access to medical care is poor? What is the business model to make it viable for companies like POC Medical Systems, which also have to meet investors’ expectations?
I agree, that for a huge country like India, the health accessibility (physical, economical, technological) is the biggest roadblock. It has been proved that existing technologies for breast cancer screening/ detection (mammography) in India has limitations, e.g. geographic inaccessibility, inconvenient, long test-to-result-time, high cost, requirement of trained personnel, and high false positive rate, personal discomforts, etc.
As per WHO statistics, every seven-minute one woman succumbs to breast cancer in India, and if we want to fight this dreadful disease, we need to adopt a disruptive technology like POCT. We, at POC have internalised the vision to change the way cancer is perceived across the world, we would like to ‘kill the fear of cancer’ by early screening/ detection.
Second biggest challenge is low awareness level. We are planning various public education activities to reach out to the masses. Various awareness initiatives like group activities, seminars, workshops are being planned out which will not only be targeted at the women audience but also their family members, so that everyone is made aware of the grave situation and the possible solution. The idea is to provide low-cost solutions to those, who need it the most.
We strive to change the way medical treatment is practised across the world, moving it away from symptom-based treatment to diagnostic/data-based treatments. We are confident of achieving our end goals i.e. ‘erasing fear of cancer’, as early detection means better cure rates. We will also take help of NGO’s and government bodies to reach the masses.
As mentioned in the last paragraph, we cannot achieve this herculean task without the help of government bodies, NGOs and corporates. We will concentrate on one state at a time and have approached state governments for their support and participation.
Which disease conditions has POCT been applied to in a public health setting?
As mentioned above, we are about to launch our test for breast cancer screening in a couple of months. However, going ahead, we expect to develop low cost tests for other cancers like prostate, ovarian, cervical, lung, liver etc.
Further, we expect to also develop tests for cardiac screening and infectious diseases like TB, typhoid, dengue, STDs, Ebola etc. In time, we also expect to develop tests for water-borne pathogens and food tests. These will all be low cost tests, which will be affordable to all strata of society.
What has been the response to MammoAlert since it’s unveiling in India in March 2018? Is it available outside the MoH&FW’s scheme?
After unveiling, POC team concentrated its efforts on procurement of quality certifications and clinical validation studies.
With respect to availability of the product, we are still in discussions with various state authorities and will be able to give details of the same at the time of launch.
What is the cost per test per woman? What are the funding strategies?
Each CD is equipped to test 10 samples and POC is planning to offer these tests in the Indian market at a very affordable cost. The final costings are yet to be reached, but we believe that we will be about 1/5th the cost of mammography.
What is the status regarding the validation studies in India?
In addition to earlier conducted clinical studies in the US, with support of world renowned breast cancer expert, Dr Raghuram Pillarisetti, we are conducting clinical validation studies at following study centres across India:
- KIMS Hospitals – Andhra Pradesh
- Amrita Institute of Medical Sciences and Research Centre – Kochi, Kerala
- Basvatarakam Indo American Cancer Hospital and Research Institute –
- HCG MULTI Specialty Hospital HCG Cancer Center – Ahmedabad
- Manipal Hospital – Bengaluru
- Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital – New Delhi
- Tata Medical Center – Kolkata
What are the regulatory certifications necessary for such diagnostic platforms? Where does MammoAlert currently figure in terms of certifications etc?
In India, the regulatory path for IVD devices is guided under non-invasive devices and the Pandora CDx falls under this category.
However, we have already acquired a CE certification from Europe. CE marking on a product indicates to all authorities that the product is in compliance with essential health and safety requirements of all directives that apply to the product and also the requirement needed for commercialisation in India.
What kind of tie ups are you looking for to improve the impact of MammoAlert in India? Which are the other resource strained countries and communities that your company is targeting to launch the test?
We are about to launch Pandora CDx technology in a couple of months. In India, we are also looking at different market sectors namely government through NGOs, door-to-door screenings, private sectors for CSR initiatives, certified diagnostic labs etc.
Over the period, this product will also be made available to other countries in Africa, China, Europe and the US. The product has already generated huge interest from all over the world. As a matter of fact, every day we receive emails from countries like Africa and Europe asking when the system will be available in their countries.