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I probed my nasal cavity for the new coronavirus—here’s what I found

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SEATTLE—I’ve kept my eyes on the Seattle Coronavirus Assessment Network (SCAN) since its formation in March, in part because I desperately wanted to know whether I might’ve caught COVID-19. Hence, “coronavirus assessment” sounded good to me. SCAN’s pilot program landed in one of the United States’ earliest confirmed outbreak regions, and its pitch—hundreds of tests a day, all conducted via free take-home swabbing kits—was open to public sign-ups.

Clearly, I wasn’t alone in wondering about possible COVID-19 contraction. (In my case, a seasonal burst of nagging cough and sinus-like chest tightness couldn’t have come at a worse time.) SCAN’s site was hounded by demand, and it typically informed visitors that a given day’s tests were accounted for, please try again tomorrow.

Roughly one month after public sign-ups began, something in the supply-and-demand chain opened up widely enough for me to successfully sign up this past weekend—as a civilian, mind you, not as a member of the press requesting special access. What follows is my anecdotal experience with what remains the United States’ only free take-home COVID-19 testing program—and what health officials and citizens alike can learn from it.

Two types of Gates: Bill and questionnaires

While SCAN is described as a collaboration between multiple Seattle-area health agencies, only one entity is named in terms of funding: “Gates Ventures (the private office of Bill Gates).” No other partner is listed in the “funding” department, not even Amazon, which is listed as a provider of “infrastructure and logistics capability.”

That funding detail matters in a sector where the public number attached to home COVID-19 tests hovers around the $120-per-test mark, including LabCorp’s Pixel kit, which received FDA approval earlier this week as the “first [authorized] diagnostic test with a home collection option for COVID-19.” As of press time, LabCorp restricts orders to those who self-identify as “a healthcare worker or first responder.”

The SCAN sign-up process includes a different gating mechanism for test requests, should its sign-up process move beyond “we are out of kits for today”: a question about symptoms common to coronavirus carriers, including fever, difficulty breathing, or cough. As a seasonal allergy sufferer, I’ve had a chronic, mild cough for the entirety of March and April, so I clicked “yes” and was able to otherwise complete the sign-up process. (Afterwards, I opened an incognito tab, went through the sign-up process, and clicked “no” on the same gating question, which informed me that I was not eligible. Then I clicked back, changed my answer to “yes,” and was allowed entry to the sign-up process.)

After filling out a questionnaire, SCAN’s instructions were clear: I needed to be available the next day to receive and use a home testing kit. It would be delivered at my designated porch or doorstep by 11am, and I would need to put my completed test into an envelope for SCAN pick-up no later than 4pm that day.

I’d like to get this out of my nose now, please

The above gallery shows what comes in the kit: a plastic swab; a sealed tube full of pink liquid, better known to medical professionals as viral transport media; a flimsy, biohazard-labeled baggie; an instructional card; and a return envelope. I read the instructions, shoved a swab into my nose, put the resulting swab into a vial, sealed that up, and placed the finished kit onto my porch. The complete process took eight minutes.

Unlike LabCorp’s take-home Pixel kit, which comes with cotton swabs, the one I received from SCAN relies on a wholly plastic “scraper” piece. SCAN representatives tell Ars Technica that the primary differentiation between its test and LabCorp’s is its use of universal transport media (UTM), the pink liquid in my vial, as opposed to LabCorp’s use of saline. “We have conducted experiments demonstrating that SARS-COV-2 virus/RNA—as well as the human RNA that we detect as a quality control measure for sample collection—are stable for up to 9 days in UTM, even at summer temperatures,” SCAN representatives said in an email to Ars Technica.

SCAN’s instructions ask users to do two things: “insert swab halfway up the nose, about 1 inch,” and “press swab against the side and rotate swab 5 times.”

I used my smartphone to film myself following these instructions, and I’ve included a few photos from that uncomfortable experience.

To be clear: the thin nature of the scraper, plus its visible one-inch demarcation, means it can reach SCAN’s recommended depth without any issue, and the mild discomfort was reasonable enough. As in, it felt like I had a piece of plastic in my nose that wasn’t supposed to be there. No pain, no itch, no jolt. I simply had a sense of, “I’d like to get this out of my nose now, please.” Either way, it’s much less invasive than the multiple inches of swab depth seen in other nasopharyngeal techniques, like this one demonstrated by the New England Journal of Medicine last week.

Notice the language in SCAN’s instructions (along with instruction-manual images in the top gallery). What might that language lead you to believe about the swabbing procedure? In my case, I assumed it meant firmly pressing the swab’s tip against the skin inside my nose, then simply rotating the whole thing—so that it scraped against one wall of my nasal cavity.

While putting this article together, I discovered that SCAN’s main portal, which I blew past in the rush of trying to secure a test, includes an instructional video. This video isn’t mentioned anywhere in the included pamphlet, and it wasn’t referred to or linked in any of the emails I received or any of the “you have successfully signed up” messaging within the Web portal (which I would have gladly watched while waiting roughly one day for my test to arrive).

SCAN’s official video reveals an entirely different kind of swab rotation, so that it touches all of the skin in your nasal cavity. (The one thing this user and I have in common is apparent discomfort on our faces when doing the swabbing part.)

Listing image by Sam Machkovech

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Prescription poop is here: FDA approves fecal slurry for unshakeable diarrhea

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Enlarge / Laboratory technicians in France prepare stool to treat patients with serious colon infections by fecal microbiota transplantation (FMT), also known as gut flora transplant (GFT) in 2019.

For the first time, the US Food and Drug Administration has granted approval for a feces-based microbial treatment, which is used to prevent a recurring diarrheal infection that can become life-threatening.

The approval, announced Wednesday, is years in the making. Researchers have strained to harness the protective qualities of the complex, diverse, yet variable microbial communities found in healthy people’s intestines and stool. Early on, rich fecal matter proved useful for restoring balance and blocking infection in those whose microbiomes have been disturbed—a state called dysbiosis, which can occur from disease and/or use of antibiotic drugs. But, our understanding of what makes a microbiome healthy, functional, and protective remains incomplete.

Doctors, meanwhile, pushed ahead, informally trying an array of methods to transplant fecal microbiota from healthy donors to the guts of patients—via enemas, tubes through the nose, and oral poop-packed capsules. Fecal microbiota transplants (FMTs) have been used to treat various ailments, from obesity to irritable bowel syndrome, to mixed success. But it quickly became apparent that FMTs were most readily effective at preventing recurrent infection from Clostridioides difficile (C. difficile or just C. diff).

C. diff bacteria cause diarrhea and significant inflammation in the colon. Severe infections can be life-threatening. In people with dysbiosis, C. diff can proliferate in the intestines, producing toxins that can lead to organ failure. Older people, those who are hospitalized, and people with weakened immune systems are particularly susceptible to C. diff, which can recur over and over in some vulnerable patients. In the US, C. diff infections are associated with up to 30,000 deaths per year.

With the pressing need for effective treatments against C. diff, regulators were forced to wade through the mucky issue of regulating and standardizing something as unruly and myriad as fecal matter. It also led to years of microbial sleuthing, synthetic slurries, stool donations, and clinical trials.

Solid success

Now, a product has finally floated to the top: Rebyota, a blend of donor stool, saline, and laxative solution given in a single treatment as an enema. It’s teeming with heavily screened intestinal microbes at a concentration of 10,000,000 live organisms per milliliter. Its owner, Switzerland-based Ferring Pharmaceuticals, screens donors and their donated stool for a long list of infectious pathogens and other health factors.

In a Phase III clinical trial involving 262 participants—the results of which were published last month—Ferring’s scientists reported that treatment with Rebyota led to a higher prevention rate of recurrent C. diff infections than in a placebo group at a rate of 70.6 percent in the treatment group compared with 57.5 percent in the placebo group. Prevention of C. diff was defined as an absence of C. diff diarrhea for eight weeks following treatment or placebo. The treatment was well tolerated, with no serious side effects. The FDA noted that given the variability of fecal matter, there is a potential that it could contain an unforeseen infectious agent or food allergens.

The approval of Rebyota is “an advance in caring for patients who have recurrent C. difficile infection,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an announcement. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI.”

Ferring—which acquired Rebyota in 2018 when it purchased its developer Minnestoa-based Rebiotix—also celebrated the approval.

“We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs. This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development,” Ferring president Per Falk said. “Today’s announcement is not just a milestone for people living with recurrent C. difficile infection, but also represents a significant step which holds promise that many other diseases might be better understood, diagnosed, prevented, and treated using our rapidly evolving insights on the role of the microbiome in human health and disease.”

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Over a year later, Musk’s Neuralink still 6 months from human trials

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Enlarge / The on-stage demo of the surgical robot practically extended into the audience.

On Wednesday night, Elon Musk hosted an update from his brain-computer interface company, Neuralink. Most of the update involved various researchers at the company providing overviews of the specific areas of technology development they were working on. But there wasn’t anything dramatically new in the tech compared to last year’s update, and it was difficult to piece the presentations together into a coherent picture of what the company plans to do with its hardware.

But probably the most striking thing is that last year’s update indicated that Neuralink was getting close to human testing. Over a year later, those tests remain about six months out, according to Musk.

Lots of tech

Neuralink involves a large series of overlapping technical efforts. The interface itself requires electrodes implanted into the brain. To connect those electrodes with the outside world, Neuralink is using a small bit of hardware implanted in the skull. This contains a battery that can be recharged wirelessly, and a low-power chip that gathers data from the electrodes, performs some simple processing on it, and then transmits that data wirelessly.

Getting all that in place requires delicate neurosurgery, and the company is developing a surgical robot to make that process safe and consistent.

On the other end of the process, neural signals have to be interpreted in near real time to understand what’s happening in a given brain region. This requires computer systems that can handle everything from patient-to-patient variability to hour-to-hour differences in brain activity. Finally, in some cases, the device will need to send information back to the brain in a way that the nerve cells there can interpret (either immediately or following a learning process).

That’s… a lot of things. And the event saw people talking about almost all of them. In many cases, the information was substantially similar to what was shown the year before. Various animals with implants were shown doing everything from playing Pong to manipulating cursors and typing using their implants—more examples than last year, but not radically different. Similarly, Musk talked a bit more about the implant’s processing capacity, now provided partly by an ARM processor. There are some indications of evolutionary progress, but there are no indications that it’s close to a finalized design that’s ready for a Food and Drug Administration submission.

Perhaps the most significant difference from years prior is the level of detail involved in the surgical robot. This time, there was both an on-stage demo of the hardware and a fair bit of time spent discussing the details of the surgical procedure it was being developed for. In the previous update, the development of the robot appeared to be lagging.

We’ve been here before

The event was said to be a general overview of the company’s activities, and the presentations seemed to cover all of the key areas Neuralink is working on. But there are issues with that approach.

One is that brain implants have been an active research area for decades. While the details are different, many things Neuralink was showing off have been done before. To an extent, that’s understandable. Neuralink is developing its own electrodes, implant, and processing system. As such, it needs to demonstrate that these systems can perform like previously tested electrodes in animal experiments. But, so far, at least, Neuralink hasn’t provided any indications that its systems are superior to those that have already been tested extensively or were on a trajectory to get there.

Meanwhile, some of its competitors progressed in the areas where Neuralink sought to differentiate itself. Blackrock Neurotech, for example, is now touting fully implantable electronics that offer wireless charging and data transfer. And the company has already sent hardware through a clinical trial and is applying for FDA approval. In fact, the company has several additional clinical trials in progress.

The custom surgical robot seems unique to Neuralink (though surgical robots are widely used for other purposes). But one of the Neuralink staff mentioned that the robot was a sticking point with the FDA, saying it’s difficult to demonstrate its safety to the satisfaction of regulators. And another one of its competitors, Synchron, hopes to avoid the need for major surgery by using blood vessels to get implants deep into the brain. And those devices have also managed to go through clinical trials already.

Another problem with Neuralink’s progress update is that it doesn’t clearly indicate that the company is ready to go to the FDA. Starting a clinical trial will mean that the company has finalized a hardware design (even if it’s working on next-generation hardware separately) and chosen a specific neural defect that it plans to treat. The update’s scattershot progress reports gave no indication that any of that has been done.

None of this is to say that there won’t ultimately be space for multiple technologies in the brain-computer implant space. Neuralink will likely eventually arrive where some of these other companies are now, or it might find a niche where its hardware is especially effective. But so far, the company isn’t sharing any information that indicates that it’s close to either result—much less accomplishing some of the more outlandish claims thrown around by Musk.

Neuralink’s presentation is available online. Oddly, for an organization run by a self-professed fan of free speech, the company has disabled comments on the video.

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A new satellite has become one of the 20 brightest stars in the sky

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Enlarge / Observation of a BlueWalker 3 pass from Oukaimeden Observatory on Nov. 16 2022. The bright star lower left is Zeta Puppis.

CLEOsat/Oukaimeden Observatory/IAU CPS/A.E. Kaeouach

Last month, a Texas-based company announced that it had successfully deployed the largest-ever commercial communications satellite in low-Earth orbit.

This BlueWalker 3 demonstration satellite measures nearly 65 square meters, or about one-third the size of a tennis court. Designed and developed by AST SpaceMobile, the expansive BlueWalker 3 satellite is intended to demonstrate the ability of standard mobile phones to directly connect to the Internet via satellite. Large satellites are necessary to connect to mobile devices without a ground-based antenna.

In this emerging field of direct-to-mobile connectivity, which seeks to provide Internet service beyond the reach of terrestrial cellular towers, AST is competing with Lync, another company that also has launched demonstration satellites. In addition, larger players such as Apple and a team at SpaceX and T-Mobile have announced their intent to provide direct connectivity services.

So while there are many more such satellites coming, AST stands out at this time because it’s the first to launch an exceptionally large satellite, and it plans to start launching operational “BlueBird” satellites in late 2023.

IAU concerns

Since BlueWalker3’s launch in September, astronomers have been tracking the satellite, and their alarm was heightened following its antenna deployment last month. According to the International Astronomical Union, post-deployment measurements showed that BlueWalker 3 had an apparent visual magnitude of around 1 at its brightest, which is nearly as bright as Antares and Spica, the 15th and 16th brightest stars in the night sky.

For a few years, astronomers have been expressing concerns about megaconstellations, such as SpaceX’s Starlink satellites. While these are more numerous—there are more than 3,000 Starlink satellites in orbit—they are much smaller and far less bright than the kinds of satellites AST plans to launch. Eventually, AST plans to launch a constellation of 168 large satellites to provide “substantial” global coverage, a company spokesperson said.

Even one is enough for astronomers, however. “BlueWalker 3 is a big shift in the constellation satellite issue and should give us all reason to pause,” said Piero Benvenuti, a director at the International Astronomical Union.

The organization of astronomers is also concerned about the potential for radio interference from these “cell phone towers in space.” They will transmit strong radio waves at frequencies currently reserved for terrestrial cell phone communications but are not subject to the same radio quiet zone restrictions that ground-based cellular networks are. This could severely impact radio astronomy research—which was used to discover cosmic microwave background radiation, for example—as well as work in related fields.

Astronomers currently build their radio astronomy observatories in remote areas, far from cell tower interference. They are worried that these large, radio-wave transmitting satellites will interfere in unpopulated areas.

AST responds

An AST spokesperson provided a statement to Ars that said the impact of its satellites must be weighed against the “universal good” of cellular broadband for people on Earth. However, the company also said it is willing to work with astronomers to address their concerns.

“We are eager to use the newest technologies and strategies to mitigate possible impacts to astronomy,” the AST statement said. “We are actively working with industry experts on the latest innovations, including next-generation anti-reflective materials. We are also engaged with NASA and certain working groups within the astronomy community to participate in advanced industry solutions, including potential operational interventions.”

To that end, AST said it is committed to avoiding broadcasts inside or adjacent to the National Radio Quiet Zone in the United States, which is a large area of land that includes portions of West Virginia and Virginia, as well as additional radioastronomy locations.

A US-based astronomer who focuses on light pollution, John Barentine, told Ars he welcomed the company’s efforts to address radio interference. He also appreciates any efforts to mitigate effects on optical astronomy. However, Barentine warned, there is no recourse for astronomers but to take AST and other companies at face value due to a lack of regulatory oversight.

“Overtures by commercial space operators who commit that their activities in space will not adversely affect astronomy are made in the absence of any meaningful regulatory oversight that mandates mitigations,” he said. “AST SpaceMobile’s stated intentions are laudable, but for now, they’re just words. So I reserve judgment pending whatever actions the company takes.”

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