A new and possibly transformative technology for rapidly diagnosing and evaluating patients based on their specific genetic profile may soon begin appearing at retail pharmacies and clinics, giving pharmacists and clinicians another tool for advancing patient health outcomes and their own practice capabilities.
Dr. Anita Goel, M.D., Ph.D.
The new tool, called Gene-RADAR and developed by Cambridge, Mass.-based research institute Nanobiosym, is now undergoing review for multiple applications at the Food and Drug Administration. In October, the technology won the $525,000 grand prize in the inaugural Nokia Sensing XCHALLENGE as a breakthrough, rapid disease diagnosis and wellness testing technology.
The Gene‐RADAR platform analyzes a drop of blood, saliva or other body fluid placed on a nanochip and inserted into a mobile device, which then detects the presence or absence of a disease’s pathogen in less than an hour. According to Nanobiosym founder, chairman and CEO Dr. Anita Goel, M.D., Ph.D., a Harvard-MIT-trained physicist and physician, it provides the same accuracy now available only in a diagnostic lab at a fraction of the cost.
In January, DSN spoke with Dr. Goel on the Gene-RADAR technology, and on its potential use in the pharmacy and retail clinic setting. Here are excerpts from that interview.
DSN: What led to the development of Gene-RADAR?
Anita Goel: This has been a 20-year journey … to break down the silos between fundamental physics, biomedicine and nanotechnology. I call it nanobiophysics — the nexus of these industries. By bringing physics into medicine and biology, we can understand biological systems at a whole new level. On a practical level, I’ve been looking at nanomachines that read and write information in DNA, using tools from physics, quantum optics and nanotechnology. We’ve found ... that by manipulating the environment, we can modulate how these little nanomotors read and write information that’s embedded in DNA. By playing with the knobs in the environment, we can actually turn the genes on and off… We’re essentially modulating these little motors, which are like tiny Xerox machines crawling up and down the DNA.
DSN: How does that ability to manipulate nanomotors translate into a diagnostic tool?
Goel: Gene-RADAR is a nanotech-enabled platform [for] … mobilized diagnosis in real time of any disease or wellness biomarker that’s based on DNA or RNA. It harnesses these nanomachines to weed out information in a genetic DNA or RNA marker. You take a drop of blood or saliva … and insert it into a nanochip, and it’s placed into our Gene-RADAR mobile device. The first-generation system we are planning to deploy is about the size of an iPad.
DSN: How would a retail pharmacist or clinician employ the system?
Goel: With Gene-RADAR, a health care worker — or even consumers themselves — will be able to genetically profile the patient. You would get information in real time, with gold-standard accuracy, to … start personalizing your meds, your nutrition, diet, exercise protocol, drugs and many more things.
DSN: What could this diagnostic tool mean for a pharmacy that incorporates it?
Goel: A pharmacy is the place where people go to not only get prescription medicines, but also OTC medicines, vitamins, healthcare products, wellness products, beauty products, consumables and personal care products. The pharmacy has really become an ecosystem for all those things. And all these products could be tailored to the needs of a particular individual, based on their DNA and RNA signatures. That’s what Gene-RADAR can do. We could stick a platform in every pharmacy, with a disposable chip that would be used to figure out what vitamins a person should take or what OTC meds are better for them. You can even personalize skin care, beauty care and personal care products because not all people react the same.
DSN: Based on that person’s genetic footprint?
Goel: Exactly. The key is you have to customize the chip [to read] the markers to go with various consumer products. So we’re building an ecosystem of these partners [for whom] we customize. For example, pharmaceutical companies are in discussions with us to build companion diagnostics to their prescription medications. We’re working with them in a collaborative fashion to customize our chip reader and software so it becomes a companion to one of their therapies.
DSN: Give us an example of how that would work.
Goel: Imagine a cancer chemotherapy they’re trying to get through the FDA. We can help to streamline with a chip which patients are more likely to respond to that chemotherapy, vs. which will be resistant to that therapy. So you do a more personalized therapy to maximize the efficacy and decrease the side effects for the patient. The pharmacist could take the patient and help determine if they’re a candidate for one therapy over another. Right now, that’s done at the doctor or at the hospital level. But in the future, you can envision this fine-tuning being done at least in part at the pharmacy level. Or the calibration of drug dosing, or using our devices because it’s quantitative as a drug-monitoring tool to see if the patient is responding to the drug, or whether they need to take alternative [therapy] because, for instance, they’ve become resistant to a certain antibiotic.
DSN: What about Gene-RADAR applications beyond prescription drugs – say, for instance, for OTC meds or supplements?
Goel: We can apply the same focus for OTC medications, vitamins, consumables, nutraceuticals, wellness products — all of these also can be personalized and customized to the patient. For example, someone deficient in vitamin D levels can use that data to help them choose the right products to … optimize their levels.
DSN: It also dovetails with the movement to empower and engage patients more effectively in their own health and wellness.
Goel: Exactly. It’s really putting the patient at the center, … taking care of his or her own health and wellness. They’re part of the same spectrum, and all these personal care products could be more tailored and more effective if you have real-time diagnostics to help you focus on which products help you the most — and also see their efficacy. Another example is … the development of a chip to monitor inflammation. Inflammation is the foundation of many of the diseases of the modern world, from cancer to diabetes and heart disease. Even the fundamental process of aging itself is thought to be linked to inflammatory pathways. So if we have a system where people can go into their pharmacy and measure their inflammatory levels in real time, and then go back and change their diet, cut out … stress levels, get into a better exercise protocol, take the right vitamins and anti-inflammatory nutraceuticals, then come back and see a direct effect on their inflammatory levels, you can start to track and — even in a preventive health care basis — get people into better wellness long before they suffer a heart attack or some other condition the health system would register. And the pharmacy can be a center for that community care.
DSN: So these chips can be c