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New Oxford machine learning-based COVID-19 test can provide results in under 5 minutes

Oxford scientists working out of the school’s Department of Physics have developed a new type of COVID-19 test that can detect SARS-CoV-2 with a high degree of accuracy, directly in samples taken from patients, using a machine learning-based approach that could help sidestep test supply limitations, and that also offers advantages when it comes to detecting actual virus particles, instead of antibodies or other signs of the presence of the virus which don’t necessarily correlate to an active, transmissible case.

The test created by the Oxford researchers also offer significant advantages in terms of speed, providing results in under five minutes, without any sample preparation required. That means it could be among the technologies that unlock mass testing – a crucial need not only for getting a handle on the current COVID-19 pandemic, but also on helping us deal with potential future global viral outbreaks, too. Oxford’s method is actually well-designed for that, too, since it can potentially be configured relatively easily to detect a number of viral threats.

The technology that makes this possible works by labelling any virus particles found in a sample collected by a patient using short, fluorescent DNA strands that act as markers. A microscope images the sample and the labelled viruses present, and then machine learning software takes over using algorithmic analysis developed by the team to automatically identify the virus, using differences that each one produces in terms of its fluorescent light emitted owing to their different physical surface makeup, size and individual chemical composition.

This technology, including the sample collection equipment, the microscopic imager and the flourescence insertion tools, as well as the compute capabilities, can be miniaturized to the point where it’s possible to be used just about anywhere, according to the researchers – including “businesses, music venues, airports,” and more. The focus now is to create a spinout company for the purposes of commercializing the device in a format that integrates all the components together.

The researchers anticipate being able to form the company, and start product development by early next year, with the potentially of having a device approved for use and ready for distribution around six months after that. It’s a tight timeline for development of a new diagnostic device, but timelines have changed already amply in the face of this pandemic, and will continue to do so as we’re unlikely to see if fade away anytime in the near future.

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VenoStent has a new technology to improve outcomes for dialysis patients

Timothy Bouré and his co-founder Geoffrey Lucks were both near broke when they moved to Dallas to join the first accelerator they entered after forming VenoStent, a company that aims to improve outcomes for dialysis patients.

Failed dialysis surgeries occur in roughly 55% to 65% of patients with end-stage renal disease, according to the company. Caring for these patients can cost the Medicare and Medicaid Services system roughly $2 billion per year — and Bouré and Lucks believed that they’d come up with a solution.

So after years developing the technology at the core of VenoStent’s business at Vanderbilt University, the two men relocated from Nashville to South Texas to make their business work.

Bouré had first started working on the technology at the heart of VenoStent’s offering as part of his dissertation in 2012. Lucks, a graduate student at the business school was introduced to the material scientist and became convinced that VenoStent was on the verge of having a huge impact for the medical community. Five years later, the two were in Dallas where they met the chief of vascular surgery at Houston Medicine and were off to the races.

A small seed round in 2018 kept the company going and a successful animal trial near the end of the year gave it the momentum it needed to push forward. Now, as it graduates from the latest Y Combinator cohort, the company is finally ready for prime time.

In the interim, a series of grants and its award of a Kidney XPrize kept the company in business.

The success was hard won, as Bouré spent nearly three sleepless nights in the J-Labs, Johnson and Johnson’s  medical technology and innovation accelerator in Houston, synthesizing polymers and printing the sleeve stents that the company makes to keep replace the risky and failure-prone surgeries for end stage kidney disease patients.

The key discovery that Bouré made was around a new type of polymer that can be used to support cell growth as it heals from the dialysis surgery.

In 2012, Bouré stumbled upon the polymer that would be the foundation for the work. Then, in 2014, he did the National Science Foundation Core program and started thinking about the wrap for blood vessels. Through a series of discussions with vascular surgeons he realized that the problem was especially acute for end stage renal disease patients.

Already the company has raised $2.4 million in grant funding and small equity infusions. and the KidneyX Prize from the Department of Health and Human Services and the American Society of Nephrology. VenoStent was one of six winners.

“It’s part of this whole ongoing effort by the executive office to improve dialysis,” said Bouré. “[They are] some of the most expensive patients to treat in the world… Basically the government is highly incentivized to find technologies that improve patient’s lives.”

Now the company is heading into its next round of animal testing and will seek to conduct its first human trials outside of the United States in 2021.

And while the company is focused on renal failure first, the materials that Bouré has developed have applications for other conditions as well. “This can be a material for the large intestine,” says Bouré. “It has tunability in terms of all its properties. And we can modify it for a particular application.”

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FDA revokes emergency authorization for chloroquine and hydroxychloroquine in COVID-19 treatment

The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via Washington Post). These are the drugs that Trump famously touted as effective in COVID-19 treatment, despite major concerns raised with the scientific validity of early medical investigations that showed they were potentially effective agains the infection beyond the ongoing global pandemic.

Subsequent studies showed conflicting results, including when one team of researchers ended elements of its clinical study into the drugs’ use early due to excess fatalities. The FDA had issued its EUA for use of chloroquine and hydroxychloroquine in late March, prompting criticism from many in the medical and pharmaceutical research community since evidence seemed very mixed in terms of its potential efficacy and risks. Then following those deaths in that subsequent clinical study, it issued a statement of precaution regarding the use of the drugs.

The FDA grants EUAs in circumstances where it deems the benefits outweigh the risks of expediting a provisional authorization for the use of therapies and devices that haven’t undergone its full, rigorous approval process for drugs and equipment. The COVID-19 pandemic has resulted in the FDA releasing many more EUAs than is typical, especially as it pertains to testing equipment used for diagnostic of the infection and SARS-CoV-19, its preceding and causal virus.

Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection. The drug’s supply subsequently experienced a number of stresses due to increased demand, which had potentially dire consequences for people with a legitimate need for its consumption due to conditions for which it is approved and clinical shown to be effective, including lupus and chronic arthritis.

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Nvidia’s top scientist develops open-source ventilator that can be built with $400 in readily available parts

Nvidia Chief Scientist Bill Dally has released an open-source ventilator hardware design he developed in order to address the shortage resulting from the global coronavirus pandemic. The mechanical ventilator design developed by Dally can be assembled quickly, using off-the-shelf parts with a total cost of around $400 — making it an accessible and affordable alternative to traditional, dedicated ventilators, which can cost $20,000 or more.

The design created by Dally strives for simplicity, and basically includes just two central components — a solenoid valve and a microcontroller. The design is called the OP-Vent, and in the video below you can see how bare-bones it is in terms of hardware compared to existing alternatives, including some of the other more complex emergency-use ventilator designs developed in response to COVID-19.

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Dally’s design, which was developed using input from mechanical engineers and doctors, including Dr. Andrew Moore, a chief resident at Stanford University and Dr. Bryant Lin, a medical devices expert and company co-founder, can be assembled in as little as five minutes, and is small enough to fit in a Pelican case for easy transportation and potability. It also employs fewer parts and uses less energy than similarly simple designs that adapt the manual breather bags used by paramedics in emergency response.

Next up for the design is getting it cleared by the FDA under the agency’s Emergency Use Authorization program for COVID-19 equipment, and then seeking manufacturing partners to pursue large-scale manufacturing.

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FDA reiterates risks of antimalarial drug use for COVID-19, as study into efficacy ends early due to deaths

The U.S. Food and Drug Administration (FDA) has issued a new warning about the known side effects of hydroxychloroquine and chloroquine, two antimalarial drugs (also used in the treatment of chronic rheumatoid arthritis and lupus), on the same day that a group of researchers published a paper in the Journal of the American Medical Association about their termination of a study investigating the potential of chloroquine as a potential COVID-19 treatment.

The drugs can have dangerous side effects, and the study written about in the AMA journal was ended early because the “primary outcome” was the death of study participants, with 22 deaths resulting. Before it was abruptly ended, the researchers found a lethality rate of 39% in the group of its subjects who took high dosages, and 15% in the low-dosage group, with an overall lethality rate of 27%.

“Our study raises enough red flags to stop the use of a high-dosage regimen, because the risks of toxic effects overcame the benefits,” the researchers said in their findings.

The FDA’s alert on April 24 doesn’t make specific mention of this study, but the 81-person phase II clinical trial represents one of the largest to date. The FDA notice does advise that reports they have received of deaths in COVID-19 patients receiving hydroxychloroquine, either alone or in tandem with other drugs, including an antibiotic known as azithromycin (which all patients in the investigation published in the AMA journal were taking), can result in “abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death.”

Hydroxychloroquine and chloroquine gained widespread attention because Donald Trump advocated them as likely effective treatments for COVID-19, despite a lack of significant scientific evidence or any clinical studies done about their safety, likely due to early, small-scale investigations that showed they might have some potential. He repeatedly touted the drugs as proven safe, since they have been cleared for use previously in treating other medical conditions, but didn’t appear to grasp that this does not mean they aren’t dangerous or perhaps deadly when taken in the context of other conditions, or for individuals with other risk characteristics.

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Virgin Orbit’s ventilators gain FDA authorization, deliveries to hospitals will start within days

Virgin Orbit has secured an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its ventilator, which the small satellite launch company designed and prototyped within the past few weeks in response to growing need for ventilator hardware to address the most severe cases of COVID-19 infection. Virgin Orbit anticipates deliveries of the ventilator hardware to start “within the next few days” now that it has secured the agency’s authorization.

Virgin Orbit designed its ventilator, which is a take on an automated version of the manual resuscitators used most frequently in ambulances by paramedics responding to calls where a person has lost the ability to breath on their own, based on guidance form a group of experts and doctors called ‘The Bridge Ventilator Consortium.” It’s designed mostly as a stop-gap and supplement to free up use of proper ventilator hardware to treat the most severe respiratory symptoms in COVID-19 patients, but should still free up a valuable medical resources that are in short supply as the pandemic continues.

Already, Vrigin says it’s manufacturing the ventilators, and is making “over 100 per week” in terms of its ongoing production rate. The initial delivery set to go out this week will be 100 units that will be shipped to California’s Emergency Medial Services Authority, for distribution depending on need in that sate.

While it has done a lot to quickly ramp up this production line and start shipping ventilators, Virgin Orbit says that it’s been continuing to build out its own small satellite launch system. In fact, it just recently flew a key final test of its LauncherOne vehicle and the carrier aircraft that brings it to its launch altitude – the last big step before it runs a full demonstration of its system, including an orbital flight, later this year.

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FDA debuts new online portal to encourage donation of plasma from recovered COVID-19 patients

One of the avenues currently being pursued in terms of developing an effective treatment for COVID-19 is through the use of convalescent plasma. Basically, that means using the liquid component of blood from people who have had, and already recovered fully from, COVID-19 to produce treatments that hopefully translate to others the antibodies they developed over the course of fighting off the virus. The FDA has created a dedicated new website seeking recovered COVID-19 donations, and explaining its potential uses.

Use of convalescent plasma is hardly a new concept: It’s been in use since the late 1890s, in fact, and was employed during the 1918 Spanish flu pandemic, albeit with “mixed results.” Modern methods could help improve the efficacy and potential of recovered plasma as a treatment method, and there are a number of drugs in development that use plasma (both animal and human) as the basic active ingredient of their approach.

The new FDA website around COVID-19 plasma donation defines what it is, and why it’s under investigation as a possible treatment. It also outlines what conditions need to be met in order for an individual to be qualified to donate (no symptoms for at least 28 days prior to donation, or at least 14 days when combined with a confirmed negative lab test for active COVID-19 viral presence), and it directs you to donate via an American Red Cross or local blood center nearby.

Why is so much COVID-19 patient plasma needed, if it’s not yet even proven to be effective in treatment of the virus? Mainly because there are a lot of efforts underway to determine whether it actually can help with efforts to combat the virus, including clinical trials for a number of different treatments, as well as single-patient treatment authorizations through what are known as emergency investigational new drug (eIND) one-off usage approvals from the FDA.

As with every potential treatment and vaccine in development to address COVID-19 at this stage, recovered plasma remains unproven, and it’s unlikely ongoing efforts to study its effectiveness will bear definitive proof one way or another in the near term. Still, there’s a growing need for plasma supplies to help further that work, hence the FDA’s decision to spur more donations with dedicated informational resources like this one.

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Researchers develop emergency ventilator based on resuscitation bags used in ambulances

The need for innovative solutions to address shortages in crucial medical equipment is greater than ever, and a new initiative from a global team of biomedical engineering experts is a perfect example. The team developed a way for resuscitation bags – common pieces of equipment carried by ambulances and paramedics around …

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Emergent BioSolutions gets $14.5M in federal funding to expedite COVID-19 plasma therapy development

Last week, we spoke to the head of Emergent BioSolutions’ Therapeutics Business Unit Dr. Laura Saward about her company’s work developing plasma-based potential treatments for COVID-19. Now, the company announced that it has received $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part …

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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 …

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