PhageTech aims to revolutionize and simplify disease diagnosis by providing actionable, molecular insight to physicians within minutes at the point- of-care.
The company was cofounded by Richard Henson, and UCI chemistry professors Gregory Weiss and Reginald Penner. PhageTech’s patented BioSensorTM technology was developed during 10 years of NIH and NSF-funded research at UCI. The company’s electrochemical biosensor platform can perform simple, low cost diagnostic testing directly from body fluids such as urine and blood without complex sample preparation or reagents, and can be used by minimally-trained medical staff.
PhageTech’s platform employs a bacteriophage (virus that infects a bacteria) substrate to detect analytes, the chemical components of interest, in body fluids. Compared to antibody-based assays, the sensor offers equal or better performance without the issues that plague semiconductor-based biosensing.
According to PhageTech Chief Scientist Phillip Tam, many viruses are remarkably stable at temperatures as high as 85 degrees C for extended periods of time, which can make it much easier to produce, transport and store biosensors based on virus-based bioaffinity layers. Viruses can be engineered to bind with almost any protein, even toxic proteins for which it is difficult to develop antibodies. And viruses that show antibody- like affinities can be produced in massive quantities and more cheaply than antibodies.
The ultimate goal for PhageTech is to develop point- of-care devices. “Ordinarily you would have to draw samples and send them out to a lab,” said Tam. “Our goal is that a doctor can draw a sample and give you the results. The potential for this technology platform is phenomenal. We can apply it to many diseases.” As the company can engineer phages to bind to a number of protein disease biomarkers, each biosensor chip can be loaded with multiple tests as needed. “The advantage is instead of looking at one biomarker, it could be multiplexed, and looking at four or five biomarkers could help you diagnose cancer earlier.” said Tam. “Basically for any given disease, we would provide a platform. Growing this phage is less expensive than making an antibody or multiple antibodies.” The PhageTech platform can also be used to detect infectious diseases, as well as for cardiac and other chronic conditions.
How the biosensor works
PhageTech engineers M13, a common bacteriophage– harmless to humans but which infects bacteria to reproduce–to bind to a specific bacteria or a protein associated with cancer. The M13 virus particles are embedded in poly (3,4-ethylenedioxythiophene) or PEDOT; an electrically-conductive polymer employed in LEDs and solar cells. The virus-PEDOT composite film is used to coat an array of millimeter-scale electrodes, creating a postage stamp-sized chip that can directly sample diagnostic biomarkers from patient body fluids without special preparation, dilution or reagents. A microprocessor sends out data to a reader.
PhageTech has already demonstrated that it can use PSMA, a prostate cancer marker, as the analyte. The company is currently engaging in proof-of-concept studies for the device in kidney disease, using human serum albumen (HSA) a well-established urinary biomarker. Next will be to develop a test for bladder cancer.
Low capital equipment cost and long shelf life without refrigeration can enable use in the home testing market and developing countries. The company intends to develop biosensors and portable readers, such as a cell phone app for physicians as well as patients.
PhageTech has exclusive, world-wide rights to the core technology from the University of California. In 2015, the company closed $2.24 million in Series A funding from a group of early stage investors co-led by Mark IV Capital and Black River Investments. “We would like to get into clinical trials this year and then file an FDA 510K.” said Tam.