Marker Test Diagnostics
January 5, 2015 Issue
The Most Powerful Name In Corporate News and Information
Urine Marker that Barcodes Urine for the Drug Testing Industry Worldwide
Marker Test Diagnostics
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 5, 2014
CEOCFO: Mr. Christensen, what is Marker Test Diagnostics?
Mr. Christensen: Marker Test Diagnostics is the second stage of a company that was originally incorporated and developed in Germany, which developed a urine marker that basically barcodes your urine to you. It is the first marker that has ever been developed and released for the drug testing industry, probably worldwide, but definitely the first drug testing marker in the United States.
CEOCFO: Would you explain how it works and why we need it?
Why we need it is
really interesting, first. There was an article out this morning from
Pittsburgh where there is a process we call pee for profit in the urine
collection process which is considered the gold standard. In most cases your
urine collection is done by limited observation and that seems to be
accepted as fool proof. That process is clearly not fool proof as we see
today’s news and I have written about this issue in a white paper published
this spring called: “Shifting the Paradigm:
A Blueprint for value recognition and process improvement in the U.S. drug
testing market”. Pee for profit is when someone is being paid off
to either urinate on behalf of the urine donor or falsify the sample or
change results. It happens every single day. Our marker eliminates that
possibility completely. We provide a capsule that dissolves in the stomach
and then immediately clears to the kidney and is in the urine within thirty
minutes. That capsule contains a very specific code and that code has to be
detected in the urine by the laboratory. For instance, if you are given
combination A, the lab has to pick up combination A. If you are given
combination A and combination B is detected we know that the urine has been
swapped. If you are given combination A and we find no marker we know that
the urine has completely substituted. By using the marker we are now able to
detect additional forms of fraud. Now we absolutely know that what is called
the false/negative urine is now captured and that data is now collected. It
also eliminates the very expensive urine collection process that provides a
major cost saving to the organization. That is because no one needs to watch
you urinate now. A capsule can be given to you; you wait for a thirty
minutes and collect the urine unobserved, the marker is in the urine.
CEOCFO: Is law enforcement able to insist you take a capsule?
Mr. Christensen: Very interesting question, because this is one of a list of concerns that we hear every single day. “How do you force someone to swallow a pill instead of peeing in a cup observed?” If you look at the forensic market, which covers the drug courts, the police departments, the medical examiner’s office, probation, parole, prisons and corrections those will become policy mandates. If you choose not to follow the policy you are admitting guilt. Now you take that and you apply that to, let us say, pre-employment or employment. I had a recent meeting with a large insurance company and their phrase to a potential new employee would be “We choose to implement this process for our drug testing policy, if you choose not to use the process, then you will not be working for us.” So you are not forcing someone to do something different it will just be a matter of policy implementation. Questions should be is the product safe and is it approved? The answers are yes they are safe and approved. The ingredients are all inactive ingredients approved by the FDA. There is no possible way to have a reaction to our product. We have got over seven hundred thousand data points over the past five years that prove that. Therefore, I see less of a mandate to do this an educational opportunity of both the customers and the end users that are going to take that to say, “We have changed our process from the observed urine collection process and now use the marker test UR Code product and here is all of the information that proves that it is safe and effective for use.”
CEOCFO: Has the legality has come into play at all or is it is a concern?
Mr. Christensen: Everything is a concern and there are a number of issues that will need to be addressed in the future. Someone might say that you cannot force someone to take something they may not want to take. We actually agree. We are not going to argue the fact that we cannot force someone to take the product. We as a company are not going to force anyone to do anything. It would be the companies, the laboratories, the physician, the insurance company that will adopt new policy. You either take it or do not take it. If you do not take it you are admitting guilt. It is as simple as that. You do not have to take it. I am sure there will be a challenge, but it does not matter. If you choose not to take it, that is fine. If you choose or ask for an observed urine collection verses the marker, keep in mind there is probably a reason for that request. Remember that twenty percent of all urines collected while someone is absolutely observing you collect urine, is false urine. It is someone else’s urine they are urinating! How do they do that? They either have an anatomical device that they are using or they have catheterized themselves before they have walked in the door.
CEOCFO: Where are you today in bringing it to market? Is it being used in Europe?
Mr. Christensen: We have had five years of experience in the German market and it has been very successful there. It is also the standard of care in the highly regulated German prison system. It is used over there routinely. We formed Marker Test Diagnostics in April of 2013 in the United States. Over the past eighteen months we have done everything to set up our company; building the necessary infrastructure that needed to be done, developed the marketing collateral, filed the appropriate FDA paperwork, and secured our brand trademark. We have also established our manufacturing process and now have product on the shelf for delivery. We have developed our US product differently than the European market. In Europe it is a liquid product and in the United States it is a soft gel capsule.
Mr. Christensen: The difference is that the instrumentation used in Germany, is called HPLC or High Pressure Liquid Chromatography. Here in the United States the most popular confirmation instrument is called LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). The LC/MS/MS instruments are much more sensitive so we reformulated the product and cannot use the same formulation. That is the reason why.
CEOCFO: What has been the reaction?
Mr. Christensen: Interestingly enough, regardless of the scale of the impact this product will have and who you talk to, whether it be governmental agencies (States) that are doing drug testing today, independent reference laboratories, corporations, insurance companies, everyone agrees this is a game changing product. So much so that it will requires a culture change, a process change and a change in thinking. So far the response is slow because it is completely new and different. However, we have been out for six weeks and we firmly believe that the market will respond favorably. We believe that over a course of years that this will become a standard of care in the drug testing industry.
CEOCFO: How does the cost compare with the standard, counting in the fact that there are so many that are wrong or faked?
Mr. Christensen: Cost is always in an issue, particularly in our society when everyone is trying to drive cost out of the healthcare and testing systems. This may be an added cost in certain markets. We really should be thinking is it really adding a few dollars to the drug test or are we addressing the bigger issue that we are recovering more drugs, eliminating false urines, eliminating the processes of cheating, and can we impact the operational costs that dive up cost? What are the cost benefit ratios of those issues compared to the cost of the product? When we sit down with insurance companies, addiction market, corrections and forensic market, they see the cost as minimal compared to the benefits of being able to have more accurate test results, particularly in the addiction market. When you are in treatment and you are cheating your tests and you are coming up negative, but yet you are really dirty and you are receiving treatment medications, there could be adverse and potential fatal reactions. From those perspectives the cost has not been an issue. I really believe that any potential cost to the system is going to be received as, “Oh, we cannot afford any more cost.” All costs and savings need to be examined but they understand that the cost/benefits are there. In two instances the insurance industries have already told us that they are looking at ways to implement the process at their cost to get better results, more accurate results, more timely results and eliminate the false negative urines. When we discussed costs, that was a minor issue for them. Therefore, I agree with you that we all should be concerned about adding cost to the system, but remember there is also a significant operational savings of about ten to fifteen dollars per sample by eliminating the observed urine collection process today and it will really is an offset in cost.
CEOCFO: Will Marker Test Diagnostics be manufacturing the capsules? What is your role? Are you selling the equipment to test with? What are you actually physically going to be providing?
Mr. Christensen: That is a great question! Marker Test Diagnostics manufactures only the capsule. We will sell the capsule to customers such as clinical and forensic laboratories, state agencies, insurance companies, and manufacturers of instruments. We are the company that manufactures the soft gel capsule. It is manufactured in the United States. We have a facility that we contract with in South Florida.
CEOCFO: What is the marketing strategy for the next six months to a year?
Mr. Christensen: There are several layers of marketing strategy that we have employed over the past eighteen months. First, we really wanted to announce, shall we say, over a period of time, that Marker Test Diagnostics would be launching our product “UR Code” in the United States drug testing market. It is a product that is going to be a game changer in the drug testing industry. So our first level of strategy was to send information to some of the largest laboratories in US to participate in an RFI (request for information) and that we were looking for laboratories interested in partnering with us. About sixty days later we then released an RFP (Request for Proposal). Really, the design of that that process was to make sure that everyone in the United States drug-testing industry knew we were coming to the marketplace. That has been completed, by the way. We were hopeful and were very successful in getting the information that we wanted out of that process. The true level that we think is going to be our best market is to identify between ten and twenty regionally based reference laboratories that cover a multitude of markets in the United States, geographically. What we do not want to do is just sell the product to the any end user that wants to buy it. This is a truly competitive advantage product for a laboratory to be able to use it in a competitive nature and begin using the product to bring on new customers and new revenue streams for the laboratory. Our plan is to limit the number of laboratories that will be licensed in the United States to use the product. If there is an individual physician or clinic or corrections, probation person that wants to use a local laboratory, that would be great and that is exactly why we are setting up our network that way. To help them increase their business and give better turnaround time to each of these end users that will be using the capsule supplied by the lab.
CEOCFO: Are you selling to the correction department or will it up to the labs to introduce it to the organizations?
Mr. Christensen: We can do both. For instance, we are looking to sell directly in licensed laboratories that will market and sell the advantages of our product. However, if a state agency calls and wants to use our product in their probation, parole and corrections departments, would sell to the state. What we really hope to do in those situations when we deal with state entities is work with the state to find a laboratory within their state to be able to detect the marker and then keep the dollars within the state. That would be extremely beneficial for the state. It bypasses the rest of the licenses within the other laboratories, because that would be a forensic based market.
CEOCFO: What is the barrier to entry for potential competitors?
Mr. Christensen: Fortunately, we have very little or no competitors in the market today. We are the only product that ever really had an impact or will have an impact on the drug testing market. It is going to take a while for someone to try to match our product because of the unique nature of the ingredients, delivery method, and significant benefits to the industry. The biggest barrier to market entry, will be the need to create a change of culture in the drug testing industry. That will be our biggest challenge - getting people to understand that the process today does not work and it can be improved. In order to do that, you have to do two things. You have to admit that you can use an orally applied marker in the marketplace and eliminate the observed urine collection process. In my opinion, that will be our biggest issue in entering the market today.
CEOCFO: Why pay attention today to Marker Test Diagnostics?
attention today? When you read every single day about the drug problems in
America and by the way it is not getting any better. We are not winning the
war on drugs, and we see every day that people are cheating the drug tests.
We know that more people are overdosing today on pharmaceuticals than they
are on illegal drugs. We know that the process today of the observed urine
collection and the false negative urine is not a fail-safe process. The
issues are getting worse not getting any better. We know that the process
today does not work. We know that it is time to change the process and
change the thinking and we feel like we will absolutely make an impact in
peoples’ lives with this product. Whether that be helping get people into
treatment earlier, helping the criminal justice, pain management, and
addiction markets provide better treatment for people and have a real impact
that changes the course of drug testing industry.
“That will be our biggest challenge - getting people to understand that the process today does not work and it can be improved. In order to do that, you have to do two things. You have to admit that you can use an orally applied marker in the marketplace and eliminate the observed urine collection process… We believe we have that product that will finally identify “The Right Person, The Right Sample, and the Right Result”!- Kim Christensen
Marker Test Diagnostics
Kim Christensen, CEO Marker Test Diagnoctics
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