The ultimate goal of miDIAGNOSTICS is to change the way healthcare is managed, through the development of fast, affordable Point of Care/Point of Need on-chip diagnostic devices.
Using small volumes of blood, miDIAGNOSTICS is developing tests integrated in silicon chips that will detect cells, proteins, nucleic acids and small molecules. Once the data is collected, it is processed within minutes, allowing healthcare professionals and patients the opportunity to make quick, accurate decisions.
“Our new generation of Point of Care/Point of Need (POC/PON) diagnostic devices will provide very fast results (10 minutes), will be easy to use (minimized or no instrumentation) and accurate (analytical performance will be comparable to the laboratory systems),” said miDIAGNOSTICS CEO Dr. Hilja Ibert. “Important diagnostics information is available in real time, which will improve the health decision making.”
Founded in October 2015, miDIAGNOSTICS has already raised €60 million. The company has more than 45 patents, as well as a sizable team of researchers.
“We have about 50 researchers from imec and JHU working on our program, all of them world leading experts in their domain,” said Dr. Ibert.
As patients and consumers globally become more health conscious, there is an increasing need for instantaneous information.
“It is our expectation that the tools developed by miDIAGNOSTICS could lead to a positive disruption in global diagnostics,” Dr. Bob Bollinger, co-founder and professor of infectious diseases at Johns Hopkins University, said recently. “They have the potential to bring affordable clinical diagnostics to people and places where no such tests were available.”
“In countries and regions with infrastructure gaps (e.g. Africa), important diagnostics tests can be done on-site.” Dr. Ibert added.
miDIAGNOSTICS’ initial application, the Complete Blood Count with three-part differential, is being designed for use in clinical settings, for conditions ranging from differentiating between bacterial or viral infections, testing for anemia or drug monitoring.
“The expertise that is available in miDIAGNOSTICS is truly unique,” said Dr. Ibert, who joined the company in February after holding leadership positions at Hologic Diagnostics Solutions International, Becton Dickinson and bioMerieux. “Imec’s and Johns Hopkins’ teams have been pioneers in bringing biological tests to chips in a silicon technology that can be produced in high volumes.
“Initially we will focus on the health care market for people, followed by veterinary and general wellness applications,” Dr. Ibert added.
The company’s first lab-on-a-chip device is designed to provide a complete blood count with three-part differentials. Because of the lengthy processes involved in receiving regulatory approvals for healthcare devices, Dr. Ibert noted that the company has set a 2019 timeline for reaching the market. Meanwhile, the plan is to partner with global players in the diagnostics and/or pharmaceutical industry to further the company’s growth.
“As a pioneer of the so-called third generation POC/PON devices, our vision is to globally shift the way in which individuals and communities manage their healthcare,” Dr. Ibert concluded. “We will prove all of our promises via world-class scientific pre-clinical research and clinical trials, and we are working on the product branding, which mid- to long-term will be recognized as the golden standard in the POC/PON market.”