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February 2, 2015 Issue

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Point of Care Screening and Diagnostic Solutions

 


Sanjeev Saxena

Chairman & CEO

 

POC Medical Systems Inc.

www.pocmedicalsystems.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – February 2, 2015

 

CEOCFO: Mr. Saxena, what is the concept behind POC Medical Systems?

Mr. Saxena: POC Medical Systems was set up in May of 2013, essentially to develop point of care screening and diagnostic solutions, which can be applied throughout the world, especially in emerging economies and third world economies where people do not have access to diagnostics in villages and tier two, tier three cities or even in tier one cities because of the cost and accessibility. The idea is that we bring low-cost solutions over to them where all this can be done in real time so we can start saving lives.

 

CEOCFO: What has been the traditional challenge in developing these low-cost solutions and what have you figured out at POC to make it happen?

Mr. Saxena: Traditionally, the problem has been that all of the diagnostics are done in a centralized lab. When you look at countries like Nigeria, Kenya, India, China, etc. people have to travel to these centralized labs, and they do not have the infrastructure or capacity to travel and the willingness simply because they lose money by not working on a particular day. As a result, they are not able to feed their families. There are many challenges in these countries, unlike here in the West. We can walk into a diagnostic lab, get a test done and go on our merry way simply because we have proper transportation and the costs are paid by the insurance companies. In these countries, people have to pay out of their own pocket, and the government has set up hospitals but they are far and few in between even though they have small physician offices in villages in India, China and Africa. If you can take the diagnostics over to these people themselves, then you can take care of it so that the diagnosis can be done in real time and at a low cost. What we have done at POC is we have developed what I like to refer to as a lab in a box, which is the size of a CD player using microfluidics. Now you can start with a simple drop of blood and literally no training for the service provider, which is the physician or the physician’s assistant there. The patient can come in, give a drop of blood, and in ten minutes while they are waiting for the physician to see them the test is done and the results are given to the doctor. The doctor can look at that and make a diagnosis based on other systems and decide whether follow ups need to be done or treatment can start. That is not possible today, and that is what we are able to achieve with the Lab in the Box (Pandora CDx) that we have designed.

 

CEOCFO: For what are you able to test?

Mr. Saxena: While we have developed tests for various biomarkers that are in the blood. However, we are starting off with the initial test that we develop for cardiac markers and breast cancer markers, and now we are focusing on the commercialization of a particular set of biomarkers that are relevant for breast cancer. You can take a drop of blood and test the patient, and what we are able to do in our test with a set of biomarkers, we are able to determine with an accuracy of 90% whether someone has breast cancer or not. The cost of the test is $2 per patient, which is a very low-cost test.

 

CEOCFO: Is that much greater than a mammogram as far as accuracy and determination?

Mr. Saxena: Absolutely, that is the advantage of the system. Because of that, you can use it for screening. Mammograms are ideal for locating where the cancer is placed in a Breast, but it is not necessarily the right screening tool. It is like a window into the inside of a breast to find out where something is located, but that is not really the tool to determine if there is something going wrong or not. It is like looking for a needle in a haystack. If you don’t know there is a needle in the haystack, then you should not waste your time looking for it, but you should spend your time determining if there is a needle there through other means and once you know it is there, then it makes sense to look for it. If you do not even know it is there, then what are you looking for? With this system now, you can determine whether there is a cancer or not, and if there is then you can use a mammogram machine to find out where it is located.


CEOCFO: Why not everywhere?

Mr. Saxena: It is everywhere. We are going everywhere, but we are starting off with those countries simply because they need something right away and they are willing to adopt it, whereas in the US mammography already exists. The mammography sector has said in the past that you do not need other molecular diagnostics, thermal diagnostics, CDs and all of that. What we want to do is position this as an adjunct to mammography as opposed to a replacement. It is ultimately needed here as well, but from my standpoint we have to get FDA approval and all of that, which will take time, whereas in a place like India all we need to do is register the device. In Europe, all we need is a CE certification and show the equivalence to existing assay technology and we can launch the product.

 

CEOCFO: How have you chosen which countries you are going to work with first?

Mr. Saxena: We are starting off with India and then into Europe and China. It is needed all over the world. As a matter of fact, every day we receive emails from countries in Africa and Europe asking when the system will be available in their countries. We just received another email a couple of minutes ago from the government of Nigeria wanting to see if we could do a public/private partnership on this. There is a massive need all over the world. We are looking to launch it later this year in India and China. Reason being, we understand the markets very well in India and China, having run an oncology biotech company in India, and we know the key players, so it is easier for me to launch it there. We already have partners lined up for it. Similarly, in China, we have an Venture group who has already invested, and we are doing a JV with the investor. The investor is called NewGen Venture Partners, to move forward with the launch in China. We are also working on a CE certification in Europe. There is only so much we can do without the Series A, and then we have to start the 510k process here as well.

 

CEOCFO: Is this a platform that you will be able to translate for other situations in the future or other conditions?

Mr. Saxena: 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 optimize it, but all of those tests can be transferred over to this. Whether you take cardiac, you take the test 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 and you mix it with certain antibodies and you incubate it for a certain amount of time and then you do a separation through an HPLC. Then you take the fluid that comes out and you run it under a fluorescent detector. That is about a 6-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 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 the 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 that whole process, and you do not need any trained personnel to do it.

 

CEOCFO: What have you learned from your previous ventures that is most helpful at POC?

Mr. Saxena: One of the major things that I have learned is if you really believe in it, you go with it. While every business plan is dynamic, you do not change directions just because you want the money. If you believe in it, you have to go for it. That is one of the things that I am doing this time unlike before in my last venture. I was talking to a certain venture capitalist and they asked why I did not go into infectious diseases, but I said no because I wanted to stick to what we were doing. We are working on the breast cancer part of it right now. We will come to the infectious disease application later on, but I am not going to change just because I want your money. I believe there is a need, and the customers are there to back it up. We need to go after what we really believe in; otherwise we should never even start. Next, do your market research initially, and once you have done all of that and you have bought into it, then go to work with full conviction. The other thing that can deliver, which we have done, is gathered a team that is fully behind what we are doing. None of our team is taking full salary, and everyone is working full time. That shows you the commitment and dedication. You need people who are committed to the cause, not to the money but to the cause and I admire my team for that. The money will happen, as that is an outcome of our target. You really need to define your cause and go after that.

 

CEOCFO: Give us a sense of what is involved when you partner with a country.

Mr. Saxena: For example, in India we are working right now with commercial organizations, and we have a team of people already besides myself who are very well connected. We are working also with nonprofit organizations, which are called NGOs in India, and we are also starting to talk with the government about doing public/private partnerships. To get access all over, you cannot just be at one level, unlike the US where you are at one level. In a country like India, China or Africa, there are at least four different levels. There are physicians you have to start dealing with, and the whole distribution network for them is very different from the diagnostic labs to the government and the nonprofit organization. Each of them has to be handled differently, and the skill sets to handle each of them are very different as well. The needs of each one of them is very different. It is important to have the right people doing that, so we are pulling that together to be able to handle that.

 

CEOCFO: What might we expect a year from now for POC Medical Systems?

Mr. Saxena: Within a year, you should be seeing the breast cancer product launched in India, China and also in Africa and Europe. We should also be looking at the cardiac screening test to be hitting the market in India by the end of this year as well. There is going to be essentially a host of different applications, and besides that 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 health care provider’s site. Similar to Apple or Samsung having developers develop 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.



 

“We have decided to focus on breast cancer screening and follow on diagnostics initially. The reason is that market is highly underserved. It is a known fact that the only way to fight breast cancer and overcome it is by early detection. Unfortunately, of the 1.6 billion women over the age of 40 (who should be screened regularly) less than 4% (60 million) women are currently screened. Most women who develop breast cancer die without ever even realizing that their death could have been prevented.” - Sanjeev Saxena


 

POC Medical Systems Inc.

www.pocmedicalsystems.com

 

Sanjeev Saxena

9253506200

ssaxena@pocmedicalsystems.com


 


 

 



 

 


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