‘We expect to change the way medical treatment is practised’

US-based screening and diagnostic solutions provider, POC Medical Systems plans to expand its footprint in India and China. Sanjeev Saxena, Chairman and CEO, POC Medical Systems reveals more to Usha Sharma about the company’s growth prospects

Tell us about the ongoing activities of POC Medical Systems.

POC Medical Systems was set up in May 2013, essentially to develop point-of-care screening and diagnostic solutions which can be launched across the world, especially in emerging and Third World economies where people do not have access to diagnostics in villages, tier II and III cities or even in tier I cities because of cost and accessibility. The idea is to provide low-cost solutions to those needed. We expect to change the way medical treatment is practised, moving it away from symptom-based treatment to diagnostic/data-based treatments.

The company’s management team has well experienced technology and biomedical professionals. How are their experiences shaping the company’s growth?

We have a very seasoned management team, some of whom are affected by diseases like breast cancer and who can now make a difference in the lives of others. Each one of them is an expert in their respective fields, which helps them position the company to develop a product that can actually make a difference.

Tell us more about the company’s latest technology invention for early and accurate screening of breast cancer. How does it function?

POC Medical Systems has essentially developed a lab in a box which looks like and functions like a CD/DVD player. It consists of four major modules as follows:

1. An instrument which is the size of a CD player
2. A microfluidics disk where a reaction takes place between the blood and the reagents

3. 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

4. The software which records and analyses the data and gives a report automatically post the test

So, the instrument which is called the Pandora CDx (runs on rechargeable batteries) can be taken to any village or in any neighbourhood or can be run in any lab or doctor’s office with minimal to no training.

The way it works is as follows:

• The lab technician or operator enters patients 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

• Places the disc into the Pandora CDx

• Selects the test and presses ‘Enter’

• The test is then performed on its own and the results are displayed and printed within 15 minutes

• The disc is then removed from the Pandora CDx and disposed

Any amino acid or protein test that is done today in the diagnostic lab can be performed on the Pandora CDx platform. If you go to any central lab, all those tests done there, can actually be transformed on this platform. Work has to be done to optimise it, but all of those tests can be transferred over to this. Whether you take a cardiac test, or for prostate, or infectious diseases like malaria, they can all be transferred on it. Let me just give you a quick synopsis. What you do in the lab today is you take blood, and you are going to process it to remove the blood cells. Once the blood cells are removed, then you take the serum, mix it with certain antibodies, incubate it for a certain amount of time and then do a separation through an HPLC. Then you take the fluid that comes out and run it under a fluorescent detector. That is about a six-hour process and it has to be done by someone who knows how to do each of these things; run an HPLC or a centrifuge. What we have done in our microfluidics disk is we have built all that in the instrumentation. You have microfluidic channels where you have the antibodies already conjugated on beads and preloaded 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 and then migrates to another chamber which has a separation median so that the HPLC equivalent is done right there. Because you are spinning the disks, the separation takes place right there, and the blood cells get separated out. At the end of this 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.

Did you receive any regulatory approvals for it? Will you be approaching for regulatory certifications?

Nothing as yet. However, the regulatory path is quite simple for IVD devices as they are non- invasive devices and the Pandora CDx falls under this category. However, we do require a CE certification from Europe and a 510K equivalence in the US and a CFDA clearance in China. Also, the process becomes quite simple since each of the five biomarkers test which we conduct simultaneously in the Pandora CDx are already FDA approved tests and hence it is easy to get approvals from regulatory authorities. What that means is, we have to show equivalence for each of the markers and show that our claims are met. Further, while we have tested samples of around 240 patients, we will conduct a short clinical study as required by FDA and use the data to file for regulatory clearances.

What strategies have the company adopted to market its product globally?

We are starting off with India and then to Europe and China. The product has its requirement all across the world. As a matter of fact, every day we receive emails from countries likeAfrica and Europe asking when the system will be available in their countries. We have received an email from the Nigerian Government requesting for a public/private partnership on this. There are plans to launch the product in India and China later this year. We understand the markets very well in India and China, having run an oncology biotech company in India. We know our key players and hence it is easier for the company to launch the product. We already have partners lined up for it. Similarly, in China, we have a venture group who has already invested and we are doing a joint venture (JV) with the investor. We are also working on a CE certification in Europe.

Will this screening test be available in India and will it be available at an affordable cost?

The screening test will be available in India at an affordable cost. We have developed tests for various biomarkers that are in the blood. However, we are starting off with the initial test that we have developed for cardiac markers and breast cancer markers, and now we are focusing on the commercialisation of a particular set of biomarkers that are relevant for breast cancer. One can take a drop of blood and test the patient and with a set of biomarkers, we will be able to determine with an accuracy of 90 per cent whether someone has breast cancer or not. The cost of the test is $2 per patient.

Tell us how many new products are in the pipeline and by when will they be launched?We will be introducing the test for breast cancer soon. However, as we go along, 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. We expect these will be low cost tests.

Tell us about the company’s future plans.

There are plans to launch the cardiac screening test in India by the end of this year. We are also looking at inviting partners to start developing different applications using our technology platform. Our technology platform costs about $50 to $100 to make, so it is a very low-cost machine that any physician can afford. We plan on placing it in every physician’s office if possible throughout the world so that these tests can be performed at their site itself locally at the healthcare provider’s site. Similar to Apple or Samsung having developers come up with applications for their cell phones, we want to have people start developing different tests using the Pandora CDX platform so that these tests can be performed on-site using our platform.

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