What The Breast Cancer Market Needs
April 21, 2015

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There are two major markets for the POC Medical Systems technology platform:

1. Point of Care Diagnostics
The point of care needs are different for different countries. The purpose is also very different for various countries.

In Emerging economies the need for Point of Care diagnostics is due to the unavailability of Labs, infrastructure, trained personnel, Cost etc, which results in loss of lives and wages etc. and hence there is a need for distributed control of labs instead of Central labs, which results in Point of Care. Also, since various diseases effect the population at large, there is a need for wide spread testing which requires low cost and automated but highly accurate Instruments. This brings about the need for screening of life threatening diseases like cancer and cardiac etc.

In the more developed countries / markets like the US, the infrastructure and trained personnel etc. exist and so the need for Point of care is less relevant. However what is needed is better tests which are lower in cost and can be used to drive the cost of health care lower and make it less painful. Hence again the need for Point of Care. In many cases, almost but not quiet, real time data is required. For examples in the case of ER/ ICU need for instant data is a must to provided therapeutics which could save lives.

2. Follow on Diagnostics

In various cases follow on diagnostics is important but may not require a Point of Care system. However, the outcome of Point of Care systems is multiplexed assays, which allow for multiple tests to performed at the same time (simultaneously). The advantage of such a test allows for multiple Protein Markers to be tested which can address different pathways. For example in the case of the Pandora CDx, we are able to test 5 different markers which are representative of different mechanism of actions. So while some one may be treated for Breast Cancer, using say Herceptin for Her-2 +ve pathway, and may recover from Breast Cancer, however they could have a relapse due to a different pathway being initiated such as angiogenesis. Ironically, they are not being monitored for this pathway and hence by the time it is discovered it is too late. Hence monitoring all markers at the same time is important at the lowest cost to determine the next course of action.

3. Lab Assay development

There are over 4000 Biotech and Pharma labs around the world and another 500 thousand diagnostic labs worldwide. All these labs could use a Lab in a box to replace outdated and expensive, highly inefficient systems which require highly trained personnel to operate the same. The reagent / consumable cost is also extremely high. All this adds to the cost of drug development as well as the diagnostic cost. The Pandora CDx has the ability to address these markets as well.

Hence, as see above the Pandora CDx is a platform Technology which can address many markets. The diagnostics Market alone is in access of $50Billion worldwide based on a recent published reports – http://decibio.com/clinical-diagnostics.php.

On the other hand the market for a Pandora CDx – Lab in a Box is represented by a replacement for centrifuges, Micro Titer plates (96 well plates), cuvettes required to do the incubation, small incubators, small HPLC’s, Fluorescent readers / Microscopes (Protein Analysis systems) which is in access of $3Billion worldwide according to a report published by Frost and Sullivan.

As can be seen, while the combined markets are quiet huge and the opportunity is large, one needs to be quiet opportunistic and focused when they are working with limited resources. POC Medical Systems has developed a highly focused strategy. 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% (60million) women are currently screened. Most women who develop Breast cancer die without ever even realizing that their death could have been prevented. The reason they do not get screened is non availability and high cost and other economical and societal reasons. The Pandora CDx offers an alternative to these women where a simple low cost blood test could be performed anywhere on the globe in less than 10 minutes and doesn’t require any trained professionals to conduct the same. Hence giving these 16million women who die due to breast cancer without ever realizing, a fighting chance. Further since we multiplex various tests a follow on diagnostics on women undergoing treatment can be performed, hence possibly preventing relapses and hence certain death. Based on cost of machine at $500 and the CD’s of $10 each the Market is in access of $3Billion just for Breast cancer screening.

Availability

Currently, there isn’t such a system available. POC Medical Systems plans to roll out the first phase of the product by August of this year in India followed by launches in other emerging economies and Europe while the US 510K is sought.

Status of Technology

The technology was licensed from Sandia National Labs and Lawrence Livermore Labs. POC Medical Systems then evaluated both and upgraded both so as to be able to integrate them. The result, is the Pandora CDx. The Pandora CDx is much more advanced than its predecessor, the SpinDx from Sandia National Labs. The technology has been tested and evaluated with various markers to test for viability and it has been found to be 10 times more sensitive than an ELISA. POC Medical Systems, is now in the process of doing an industrial design which is expected to be completed in the next couple of months, post which we will start the CE process which is expected to take between 2 to 4 months. Post that we expect to register the Pandora CDx in India and other South East Asian countries and launch the product. While registration is underway in South East Asia, POC will start the CFDA process in China and the 510K in the US.

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