New Multi-Test Micro-Lab Ready for Clinical Studies

Developer of a first-of-its-kind micro-lab to help clinicians in almost any setting make earlier treatment decisions, prepares to test the system in clinical studies.

Ativa Medical Corp. (St. Paul, MN, USA) has been developing an innovative micro-lab that incorporates multiple detection methods – allowing many, currently 25, primary blood tests to be performed with a single portable instrument and test cards. It will make critical hematology and chemistry testing affordable for practitioners in healthcare sites around the world. The Ativa micro-lab has advanced to demonstrating equivalence to central lab-based systems that cost many times the price. Ativa will next proceed with clinical studies towards regulatory approval of its tabletop micro-lab for clinical use.

According to a 2014 report by Lab Tests Online, "(Central) laboratory testing is subject to many factors that potentially could adversely affect the integrity of the sample and prevent the timely reporting of an accurate test result." The Ativa system will improve patient experience by reducing time-to-diagnosis and reducing the chances for lab test errors and misdiagnoses as it does not require sample handling by multiple healthcare staff.

The micro-lab is a compact system that combines flow cytometry, electrochemistry, colorimetric testing, and imaging – into a single system. Each test is run on a single, inexpensive, disposable card specifically tailored to the test of choice. The technology, including key microfluidic components, sample preparation, disposable test cards, diagnostic tests and instrumentation, is covered by 80 US patents and 184 patents worldwide. There is currently no single instrument capable of performing the 25 primary blood tests.

Traditional central lab-based testing has not fundamentally changed over the past 30 years. Relying on an external lab for critical tests presents an expensive and time-consuming logistical challenge that means providers in low and mid-volume care settings have no practical solution, forcing physicians to make diagnoses without the data. In much of the developing world there is limited or no access to diagnostic testing due to the prohibitive cost of traditional lab equipment and the lack of medical technicians required to perform the tests.

James M. McNally, PhD, and Ativa's new president and CEO, brings 25-plus years of executive leadership experience in the medical device and diagnostic industry, including most recently serving as vice president of Quest Diagnostics' Products Division, including its point-of-care companies. He has been awarded 12 patents for his healthcare and diagnostic innovations. "In my career, I've had the opportunity to review hundreds of diagnostic instruments and businesses; we believe Ativa's system will be able to deliver central lab quality results in about 5 minutes during a single office visit," said Dr. McNally.

"Ativa's micro-lab, with the footprint of a toaster, will ultimately be able to accurately and efficiently test up to 90% of Medicare's top 30 blood tests," said Dr. McNally, "Ativa's patented disposable microfluidic cards need only a drop of blood yet compete with the quality and consistency of large lab instruments, based on our preclinical complete blood count results. The Ativa system holds great potential where speed-to-diagnosis is critical, such as emergency rooms and urgent care facilities, as well as in private physician offices and retail clinics and pharmacies. Because of the system's affordability and portability, we believe there will be great interest in this system in emerging countries, many of which lack access to quality lab testing of any kind."

The device has not yet been evaluated, cleared, or approved for use by the US FDA; safety and effectiveness have not been established. "Jim McNally's experience with an array of point-of-care products, including navigating commercialization issues and the FDA, gives him important insights to lead Ativa at this stage," said James B. Stake, chairman of Ativa's board of directors, "This system presents a breakthrough product in clinical diagnostics."

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