NEW YORK (360Dx) – A three-year, $1 million National Science Foundation grant to develop technology that combines implantable sensors, wearable devices, and software could eventually lead to a diagnostic test for non-small cell lung cancer, according to its developers at the University at Buffalo.
The grant recipients at UB are working with Intel, Garwood Medical Devices, and Roswell Park Cancer Institute on an implantable nanoplasmonic sensor that would combine with separate laser and detector microarrays to identify the presence of Cyfra 21-1, a biomarker of non-small cell lung cancer.
The developers said that they realize that a diagnostic platform, if successful, is probably at least five years away from launch, but they have a commercial development plan and team in place.
The system would provide the advantage of enabling continuous monitoring for the presence of the lung cancer biomarker in blood, Josep Miquel Jornet, assistant professor of electrical engineering at UB and the grant’s principal investigator, said in an interview.
With lung cancers, early detection improves the chances of recovery or extending a patient's lifespan, and Jornet noted that consulting oncologists at Roswell Park Cancer Institute advised the team that blood samples for current lung cancer patients are sometimes drawn only once per month, primarily because of the inconvenience presented by doing laboratory-based testing.
The lure for a clinician of the wearable system with an implanted chip is being able to access samples frequently, and as a result, detect changes within patients almost as they happen. "Clinicians would like to see the evolution of things on a daily or even on an hourly basis, and if it's inexpensive, why not do it," Jornet said.
However, the diagnostic system is still in its early stages of development and some of its most promising features could also be among the most challenging to overcome as the system is moved along a path to commercialization, he noted.
For example, the system concept relies on a sensor implanted under the skin and near the wrist where it would access capillary blood in making a diagnostic decision. Implanting a device under the skin brings a unique set of challenges, Jornet said, not the least of which is that it should not move under the skin; its measurement should not be impeded by blood fragments other than those that reveal the biomarker of interest; and the device shouldn't produce an infection.
Additionally, communication of patient data from a wearable wristband to a smartphone would need to be protected and made secure, he said.
For some of those reasons, such a device is also sure to come under scrutiny from the US Food and Drug Administration, Jornet noted. However, UB's commercial partner Garwood Medical expects to manage both the regulatory and tissue compatibility challenges.
Garwood has developed technology for orthopedic implants that breaks up biofilms and helps control bacterial infections in bone and on surrounding tissue. The firm will work with UB to take the system through the regulatory process, Wayne Bacon, Garwood's president and CEO, said in an interview.
Its launch will depend on its degree of technical and clinical success, and "the approach to the FDA," he said, adding, "It's a little early to comment on how exactly we would approach the FDA because there's so much work to be done [prior to applying for clearance]."
Most likely, the firm will apply for de novo clearance designed for low- to moderate-risk devices for which nothing similar exists in the market, he added.
Showing that the system will effectively protect patients' data is another important aspect of its development, Jornet said. To that end, UB is collaborating with Intel to develop system software that would provide more secure data transmission and storage.
Another important feature that will probably garner FDA attention is the implanted sensor chip, Jornet said. As a result, UB is developing a passive chip that becomes active only when light is shone from laser nanoarrays. The passive device should be more agreeable to the FDA than one that actively generates signals and would, therefore, need a battery, he added.
Even before the group can think about applying for FDA clearance, it must put the device through several technical and clinical iterations, Jornet said. At present the researchers are designing and building the system's components, including reducing the size of its lasers, detectors, and other components so that they can be worn on the wrist and communicate with the implanted chip and a smart phone.
The system operates by shining laser light to the sensor chip from coordinated nanoarrays and sensing the strength of the returning light using nanosize detector arrays. The implantable sensor, 10 micrometers squared, is made mostly of gold.
In addition to fabricating the prototype chip, the group already has a nanosensor array and it has manufactured an operating nanodetector that it needs to use as a basis for a nanoarray detector, Jornet said.
The group noted that in the larger context of wearable devices used in healthcare, their project could expand on the current capabilities of wearable devices used to check heart rate, calories burned, and provide other relatively simple measurements.
Jornet said that their integrated system will provide a faster and more accurate way to diagnose and monitor diseases than conventional wearable technologies by leveraging the state-of-the-art in nanobiophotonics and wireless communications.
The project could have implications beyond lung cancer detection. The system could be used to detect other diseases with biomarkers found in blood, he noted. If the team is successful in testing the use of the Cyfra 21-1 biological marker for non-small cell lung cancer, they could experiment with implanting additional markers for lung cancer, other cancers, and even infectious diseases, Jornet said.
The researchers hope to have the fundamental components of the system in place by next September, which would mark the end of the first year of the NSF-sponsored project. In year two, they will work on integrating the components, and in year three, they will conduct testing on cadavers with blood pumped through veins within their forearms and, separately, on artificially grown tissue with blood vessels.
Garwood Medical would build prototypes and conduct early production runs of the system, Bacon said. However, manufacturing would probably be done by an industry partner that has the resources and global reach to also market the system, he added.