This project develops new diagnostic and toxin detection products based on biosensing mechanisms developed by extensive previous NSF support. The bio-sensing mechanisms incorporated in the sensors are based on protein-laden chemically woven hydrogels and are broadly applicable to aqueous borne toxins. The project will focus on transforming fundamental science into practical technologies that are driven and defined by the opportunities in multiple markets including disease diagnostics, physician office laboratories, research facilities, agriculture management, veterinary medicine, food processing and quality control, allergen management, home health care, and nursing homes / long term care facilities.
As conventional biosensors rely on the associative binding between proteins (antigens and antibodies), this project develops sensors based on the dissociation and displacement of protein binding partners. This fundamental difference, and the new knowledge mentioned above, will enhance science and technology at the conceptual level in addition to improving the quality of current sensor technology, and thus likely change the landscape of research in sensor development. The sensor technology has the potential to benefit many segments of society, including rapid detection of infectious diseases, accurate and fast assessment of drinking water quality, and preparedness for emergency response and combating other threats. Nascent and emerging market opportunities enabled by this technology for personal health care will also be explored.
Our technology offers a quick and sensitive test to a wide range of biotoxins that includes biomarkers for diseases, toxic bacteria and biological agents that can be potentially used in biochemical warfare. Our initial philosophy is to offer a quick and user-friendly sensor technology for certain market settings. At the end of our ICORPS training, our philosophy did not change, but our founding allows us to narrow down to one or maybe at most two suitable markets for our technology. During the ICORPS training, we (Principal Investigator Yan-Yeung Luk, Entrepreneurial lead Andy Basner, and Industrial Mentor: Timothy Labreche) interviewed more than 87 practitioners and leaders from national laboratory, private physician practice, farming industry, contract laboratories, and nonprofit organizations. Overall, the market for biosensor technology can be considered for (i) human health/medical industry, (ii) in-home use diagnostic kits, (iii) intense care units and new disease targets, (iv) food and meat industry, (v) water quality control, and (vi) home security. Diagnostic tests in public health industry are inefficient. In this industry, the sensor technologies are used by all practitioners, doctors and nurses, and even in some cases patients themselves in a rather indirect way. With the major exception of pregnancy test and to a less used extent ovulation tests, most of the tests are sent to a centralized laboratory, which large quantities are carried out by certified technicians. The industry is heavily regulated, and operates, in our opinion, in a rather inefficient way. Most of the tests have a waiting period of time, for which the patients could otherwise benefit from quick results and turn around. In contrast, whereas our concept is for quick tests by the operator, whether it is a nurse or a doctor himself almost immediately at the bedside; most of the satellite laboratory have been shut down and turn into a sample collection centers which collects the samples to be tested from the patients or doctors and transport to a big centralized laboratory in another state. Thus, our philosophy of our technology is in opposite trend of the industry. As a result, we believe that public health industry in hospital and private practice are not feasible for developing a business based on our technology, at least not right away. In home test kits, however, is an entirely different story. The most visible example is pregnancy test kit, which is a billion dollar industry. Even the industry is mature, new pregnancy test kits still appears in the market, presumably with different level of improvements. In this context, test kits for sexually transmitted disease (STD) appears to have a significant need for quick diagnostics, for the following reasons. First, when pushed for an answer why STD tests are sent out to centralized laboratory by organization such as planned parenthood or STD centers, the real answer is essentially that cost and management workload for running those test are too high, and thus no incentive for the practitioners to carry out those tests without delay. The need for quick testing however is evident from the uncountable internet sites that "offer" STD tests by asking the "patient" to go to a sample collection site or to send in the sample themselves. Examples include www.questdiagnostics.com , www.stdalert.com , and many others. This flourish of internet business is mainly due to the fact that patients with potent STD would like to remain unidentified. When asked about "in-home" test kit for sexually transmitted diseases, an interviewee (Director of a diagnostic laboratory) appeared to be "excited", and stated that it should have a market. For a specific example, that laboratory works with college health centers because the students often like to "by pass" the insurance companies, so that their parents would not know that they are being tested for STD diseases. The interviewee also said, not sure as joke or not, that false positive is good, and false negative must be avoided. The interviewee also mentioned that the assay must be like pregnancy test that it is easy to use. It should be so easy that the kit could be a waived test kit from FDA. This information suggests that the FDA hurdle can be significantly reduced. With this knowledge, we believe that our technology could potentially be applicable for in-home quick tests for STDs. For the similar reasons, our technology may be useful for intense care units and new disease targets, but our technology appears to be not cost effective for food and meat industry and water quality control. Finally, homeland security does not seem to be a immediate market for our technology, but rather a source for funding of research.
