As CEO and a co-founder of Spartan Bioscience, Dr. Paul Lem has led the closely-held company through FDA and Health Canada approval of the Spartan RX CYP2C19 System, a breakthrough technology that provides fast and inexpensive sample-to-result DNA testing. One-in-three people carry genetic mutations and carrying a CYP2C19 mutation can impair drug metabolism. Some 15% of all prescribed drugs are metabolized by CYP2C19 enzymes, including anti-platelet drugs, anti-depressants and proton pump inhibitors. In May, the company introduced the Spartan Cube, the world’s smallest commercial molecular diagnostics device that enables unprecedented portability and convenience. In this interview with BioTuesdays.com, Dr. Lem discusses the thinking behind the Spartan Cube, its benefits and potential for home use.
What gave you the idea for the Cube?
Our RX device was FDA-cleared for in vitro diagnostic use, but without a CLIA-waiver, we are only able to target hospitals in the U.S. We quickly realized that we needed to bring a smaller device to doctor’s offices, pharmacies and eventually to the home market. The system also needed to be less expensive and easier to develop tests for. So we think of the two devices as going after different markets. The Spartan Cube will be our platform for a CLIA-waiver and we’re working on an application and hope to apply to the FDA soon. In Canada, we are expanding into pharmacies, hospitals and doctor’s offices.
What was your thinking behind the design of the Cube?
Spartan Bioscience’s mission is to bring the world’s first personal DNA analyzers to everyone, and a small device makes this possible with portability and convenience. We wanted to develop a device that combines ease of use, speed and brings the price point down to where immunoassays are. Immunoassays have become a very popular tool for detecting or measuring specific proteins or other substances. Once DNA testing reaches ease of use, speed and reduced costs, the procedure will be the preferred route for personalized medicine. In the same way that mainframe computers gave way to smartphones, high-throughput mainframe DNA analyzers in central labs will give way to on-demand DNA-testing devices.
What are some of the features of the Cube?
The Spartan Cube is exceptionally small. You can literally hold it in the palm of your hand and it takes up the space of a coffee cup. At only four inches cubed in size, the Cube is portable and fits easily into any space, whether in a hospital, doctor’s office, or pharmacy. The Cube is taking the complexity out of DNA testing and its simple design enables anyone to quickly perform DNA testing. Whether you want to quickly test a sick patient in a doctor’s office or run a genetic test for drug response, the Cube will provide results when and where you need them. It connects wirelessly to a tablet or laptop that displays test instructions and results with an intuitive touch interface. In addition, the Cube can go from sample-to-result in 30 minutes. That’s a fraction of the time compared with traditional lab-based testing. Doctors, patients, and other users can get immediate results rather than waiting for a lab to run a test. The Cube is a polymerase chain reaction (PCR)-based platform for a variety of molecular diagnostic applications, including infectious disease, pharmacogenetics, and food and water testing for things like E. coli or listeria for environmental monitoring.
How is the Cube applicable for home use?
We like to think of the Cube as an Xbox with multiple applications. Suppose you had a child at home with sore throat. A cheek swab applied to our strep throat cartridge and inserted into the Cube would determine whether your child has strep throat or not, thereby avoiding a trip to the doctor or emergency room. Flu testing could also be available with the Cube in order to determine whether a fever and chills is flu or not. Our vision is to have cartridges for many of the common ailments that doctors commonly see like strep throat, flu, sexually transmitted infections and personalized drug response information before filling a prescription.
What’s the Cube going to cost?
We will be launching the Cube and an initial assay menu at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo in Philadelphia on July 31. It will be priced at about the cost of a personal computer because we want to make it affordable for everyone.