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Johnson & Johnson will help support Alveo through its clinical trials and FDA approvals
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To say we were underprepared for a disease like coronavirus would be an understatement. We're now months into the crisis and we're still, somehow, not anywhere near testing enough people to be able to effectively track the disease and control it. One way to potentially have alleviated that problem would have been if individuals could test themselves for the virus in their own home, without needing someone to send it to them.
That is exactly what Alveo Technologies wants to provide. The company, which is developing technologies that allow for real-time, at-home detection of infectious diseases, announced on Thursday that it entered into a research collaboration with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which will help bring its be.well platform to market.
"Johnson & Johnson sees a lot of technology, they see a lot of startup companies, and that we are selected to collaborate, to work with them, means that we went through a vetting process that really validates our technology, our culture, our vision," Ron Chiarello, PhD, Founder, CEO and Chairman of the Board of Alveo, told me in an interview.
"That validation does give us added confidence. That is a big boost for us, and the internal and external validation is really great."
The be.well platform
Founded in 2014, Alveo's mission is "to help relieve suffering," Chiarello told me by giving people technology that can allow them to not only diagnose faster, but to get cured as well.
"The analogy I like to use is if you walk into your kitchen, it’s filled with technology: blenders, mixers, microwave ovens, convection ovens, all this stuff. New cars have a couple hundred sensors on them and you know everything about your car, like fluid levels and tire pressure. But when you go into your medicine cabinet in your bathroom, maybe you have a scale or a thermometer. It seems silly to me that have so much technology spread around our lives but not when it comes to knowing about our health, about the body, about the human system," he said.
"That's what Alveo and be.well platform is about: unlocking healthcare technology that has traditionally been siloed in hospitals, clinics, doctor’s offices, and bringing it closer to people."
The be.well platform comes with one analyzer, five testing cartridges, and seven nasal swabs. Patients simple take the swab and stick it in their nostril to get a mucus sample, they put the that sample into a disposable cartridge which is inserted into the analyzer. That then communicates wirelessly with any mobile phone which will have Alevo's real-time healthcare app. Patients can also fill out a questionnaire with personal health information, including their symptoms. Depending on what disease they have, the patient will be guided toward specific treatments or interventions.
"For COVID-19, you can begin your 14 day quarantine. The World Health Organization quotes a study from France saying that ibuprofen likely exasperates COVID-19, so here’s an alternative treatment," Chiarello explained.
"Those kinds of intelligence interventions are all communicated so the data flow goes two ways: from the user, the consumer, to the professional community, and then back to that individual."
Johnson & Johnson partnership
The be.well platform started out by detecting the flu and Respiratory Syncytial Virus (RSV), which is the number one killer of kids under age five worldwide. More recently, the company added a COVID-19 test as well.
The company has not yet undergone clinical trials for any of these tests at the moment, but the plan is to start trials for the flu and RSV in September, and then to submit its application to the FDA in December so it can approval to start selling the kits next year. In terms of COVID-19, the company has applied for Emergency Use Authorization (EUA) from the FDA, and it plans to start those human trials in May.
The trials and FDA authorizations are where the partnership with Johnson & Johnson will come in handy, as the company has pledged to offer financial, technical and regulatory counsel to Alveo.
"You have to understand that our product is quite different than anything the world has seen before, where you’re putting pretty sophisticated technology in the hands of the everyday person, non-technically trained individuals. So, there’s a human factors element: can people self squab? Can they follow the instructions to use the product? They’re sort of like a psychological or emotional component. Would parents with young children be comfortable swabbing and performing this test at home?" said Chiarello, explaining that Johnson & Johnson has already helped the company conduct these studies through its BabyCenter.
"That whole human factors element that might not be obvious is very, very important and, in fact, it’s part of our FDA regulatory process that we need to show that people can use it effectively, including can they upload the app, can they follow the instructions and so forth."
Johnson & Johnson is also putting their knowledge and experience with regulatory approval to use in order to help Alveo navigate those hurdles.
"These viruses can be kind of tricky in terms of clinical symptom differentiation. What are the viral loads you need to detect? All of those technical biological sciences and details, you’re dealing with world experts at J&J, so they help us in that area as well, which helps us make the product," Chiarello explained.
"One could argue that J&J is the most successful healthcare company in the world, and so they have tremendous resources and talent, and they have financial resources, so we’re benefiting from all of that in this collaboration."
As for what Johnson & Johnson gets from the partnership, in part it will allow pharmaceutical companies, like Janssen, to make sure they are getting antivirals to patients in a timely and effective manner.
"If you’re going to deliver a therapeutic to an individual, you want to know what they have, and you want to know that your antiviral is going to be effective to help that person. Without universal diagnosis, you’re limited in how many people you can help. If you’re waiting around for people to show up to an emergency room to help them the flu or RSV or COVID-19, that’s not really effective," Chiarello explained.
"We know with the flu and with RSV that you pretty much have no more than a 48 hour window to diagnosis the case for antivirals to be effective, so you want to have really rapid turnaround."
Even if a test takes 15 minutes it will have diminished results if it takes two days to get to a patient, which is why having a platform like be.well, where patients can take the test right away and immediately have the results uploaded and sent to their doctor, is so important.
"There’s a need to know now that the medicine can work and get to the individual in time and work. That’s all part of the motivation for having diagnostics close to the consumer, more readily available, good price points, where a lot of people can use it."
Empowering the patient
Ultimately, Chiarello doesn't see Alveo as a revolutionary product but an "evolutionary one," as it's taking part in a years-long trend of putting healthcare into the hands of the patient.
"I’m siloing technology and getting it into the hands of individuals and empowering individuals to know about their own health. I see this as a big trend. There are studies that are showing that in the U.S. people are more and more comfortable with do-it-yourself tests," he said.
"We’re taking technology that, up until now, was reserved for clinical labs and doctor’s offices, and we’re bringing it to the home. But then we’re connecting it with what I call ‘generation-C,’ or ‘generation connected,’ so having the healthcare application program as part of our product offering offers tremendous synergy with the way society is going."
There's been a big push towards telemedicine and virtual care thanks to COVID-19, but Chiarello believes it only accelerated this movement, while also exposing the dangerous lack of emphasis that the healthcare system had been putting on infectious disease.
"Infectious disease has not been a top attractor in terms of other diseases like cardiovascular disease, oncology and diabetes that we have invested in. That's part of the reason why this pandemic has surprised us, has blindsided us, because we weren’t all that that prepared for testing for antivirals. No one’s ever seen COVID-19 before, but at the same time, many people predicted would this happen, and, lo and behold, here it is," he said.
"I feel, this is a bit of a wake up call to bring attention to the need to test and come up with therapeutics and interventions and best practices around these infectious diseases. We love science and technology and so lets apply it to this problem. I think we’ll have great solutions in short order and hopefully these kinds of things, where entire economics systems are brought to a halt, don’t happen, or happen on a much smaller scale. That’s the objective: for people to not only live longer but live extended healthy, effective lives."
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