veterinary medicine

Auto Added by WPeMatico

A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week.

The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. It’s size, and the fact that it can produce either a positive result in just five minutes, or a negative one in under 15, mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

Unlike the rapid tests that have been used in other countries, and that received a new type of authorization under an FDA guideline that doesn’t confirm the accuracy fo the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’ DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.

The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.

In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.

Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.

YC startup Felix wants to replace antibiotics with programmable viruses

Right now the world is at war. But this is no ordinary war. It’s a fight with an organism so small we can only detect it through use of a microscope — and if we don’t stop it, it could kill millions of us in the next several decades. No, I’m not talking about COVID-19, though that organism is the one on everyone’s mind right now. I’m talking about antibiotic-resistant bacteria.

You see, more than 700,000 people died globally from bacterial infections last year — 35,000 of them in the U.S. If we do nothing, that number could grow to 10 million annually by 2050, according to a United Nations report.

The problem? Antibiotic overuse at the doctor’s office or in livestock and farming practices. We used a lot of drugs over time to kill off all the bad bacteria — but it only killed off most, not all, of the bad bacteria. And, as the famous line from Jeff Goldblum in Jurassic Park goes, “life finds a way.”

Enter Felix, a biotech startup in the latest Y Combinator batch that thinks it has a novel approach to keeping bacterial infections at bay – viruses.

Phage killing bacteria in a petri dish

It seems weird in a time of widespread concern over the corona virus to be looking at any virus in a good light but as co-founder Robert McBride explains it, Felix’s key technology allows him to target his virus to specific sites on bacteria. This not only kills off the bad bacteria but can also halt its ability to evolve and once more become resistant.

But the idea to use a virus to kill off bacteria is not necessarily new. Bacteriophages, or viruses that can “infect” bacteria, were first discovered by an English researcher in 1915 and commercialized phage therapy began in the U.S. in the 1940’s through Eli Lilly and Company. Right about then antibiotics came along and Western scientists just never seemed to explore the therapy further.

However, with too few new solutions being offered and the standard drug model not working effectively to combat the situation, McBride believes his company can put phage therapy back at the forefront.

Already Felix has tested its solution on an initial group of 10 people to demonstrate its approach.

Felix researcher helping cystic fibrosis patient Ella Balasa through phage therapy

“We can develop therapies in less time and for less money than traditional antibiotics because we are targeting orphan indications and we already know our therapy can work in humans,” McBride told TechCrunch . “We argue that our approach, which re-sensitizes bacteria to traditional antibiotics could be a first line therapy.”

Felix plans to deploy its treatment for bacterial infections in those suffering from cystic fibrosis first as these patients tend to require a near constant stream of antibiotics to combat lung infections.

The next step will be to conduct a small clinical trial involving 30 people, then, as the scientific research and development model tends to go, a larger human trial before seeking FDA approval. But McBride hopes his viral solution will prove itself out in time to help the coming onslaught of antibiotic resistance.

“We know the antibiotic resistant challenge is large now and is only going to get worse,” McBride said. “We have an elegant technological solution to this challenge and we know our treatment can work. We want to contribute to a future in which these infections do not kill more than 10 million people a year, a future we can get excited about.”