A focus on relatively painless, quick diagnostic testing didn’t just bring Theranos to the forefront (despite its recent hurdles). Companies like NOWDiagnostics, established in the beginning of 2014, have had a similar focus and have found success in taking a drop of blood from the fingertip and allowing for solid results in just minutes.
CEO Kevin Clark spoke in an interview about what makes NOWDiagnostics’ ADEXUSDx product different and the particular value it holds in this area of healthcare.
Can you share a bit about how your technology works and what makes it different?
What it boils down to is we have six granted patents, three more applications pending, it’s all around microfluidics and how the device is put together to test for anything from HIV, food intolerance to pregnancy. Think about glucose testing – prick your finger, lay it down, 10 minutes later you have your result.
How will this be distributed for use, in a clinic or at home?
Depending on what the technology is being used for, which diseases, there are going to be different markets. Our ultimate goal would be to take some of the products over-the-counter (OTC), but there is a huge professional market for point-of-care.
The pregnancy test for example – there are tons of urine-based tests out there and a few blood-based tests, but there aren’t many tests next to the patient, point-of-care, that have this level of accuracy. Let’s say in the emergency room, when women walk in, before anyone can do anything, they have to do a pregnancy test on them. An article was recently published showing that there is a 17 percent false result with urine tests, but for our small device you get the same results that you would get from full-blown laboratory testing. But we can do it right next to the patient.
For OTC use, gluten intolerance would be a great one.
Beyond HIV, pregnancy and food-intolerance testing, what other diseases could this test for?
There are 36 that we have focused on, which include all of the sexually transmitted diseases. Then there is another group that we call Dr. Mom, which includes strep throat, pink eye, those types of tests could help mothers or caregivers know, “should I really go to the doctor or not?” And the food intolerance tests could cover up to 95 percent of the common food allergies.
The devices would be structurally the same, but individualized for particular diseases or conditions?
Each test is different. It’s based on what antibody/antigen you put on it and what you’re looking for. It’s not all of them at the same time, but the format is all the same. It would be one of our goals to have multiple results for different conditions in one test, but the volume of blood limits this. You need a reading that the human eye can determine whether or not something is positive or negative. But we are working with a company that could create a reader that could determine more from the tests in the professional market.
What are your thoughts on what has been going on with Theranos and how does your company differ?
Well we’ve been working with the FDA from the very beginning. We are focused on point-of-care, it seemed to me that Theranos was more focused on regional-based laboratories. I’m not sure I understood their entire focus. I get this question a lot from investors, and I’ll show them the device, show them how it works and show them the FDA approval. There is nothing behind closed doors. This is truly a one-step process with results in just 10 minutes.
The ADEXUSDx products are currently being sold in Europe and the FDA approved product is starting to be sold in the U.S.
Clark says the challenge will be with OTC approval because it must be very simple for anyone to use, but the company is starting the first clinical trials with that focus and claims to have at least 99 percent success with specificity and sensitivity.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Photo: Screenshot via NOWDiagnostics
