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Everlywell was one of the first startups to announce that it was working on a self-administered, at-home COVID-19 diagnostic kit, but it initially sought out to ship kits before regulators made clear that this was not in line with its guidelines. Everlywell then became intent on working with the FDA to secure a proper Emergency Use Authorization for its kits before sending any to consumers, and that approach has paid off with the U.S. drug regulator issuing an EUA for Everlywell’s tech today.

Everlywell‘s COVID-19 Test Home Collection Kit is the first standalone sample collection kit to be granted a proper EUA by the FDA. Other kits have been in use through physician-prescribed and directed collection, and others still have been authorized specifically for use with one test (where provider of both kit and test are the same). This approval is unique because Everlywell is offering its sample kit independent of any specific testing lab, and can work with a variety of labs to potentially provide a broader testing footprint.

The test kits are then sent to one of two labs currently authorized under separate EUAs for COVID-19 testing, and the administration notes that this could expand to other test providers in future should they file for an EUA and provide the requisite data that goes along with the verification required for that emergency approval. The FDA cites Everlywell’s work in collecting and presenting data from studies including those supported by the Bill and Melinda Gates Foundation to show that samples collected at home using its nasal swab collection method remain stable during shipping.

That data is also now available to others looking to provide similar test kit offerings, the FDA notes, which should reduce the burden of proof on anyone looking to gain authorization for a competing product. That could potentially open up testing even further, reducing a bottleneck that many public health professionals see as one of the key drivers of a successful recovery.

“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a statement provided to TechCrunch. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”


TechCrunch

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.


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Long and short distance travel have all but stopped for many people at the moment. But looking forward to a time when that may no longer be the case, a company designing flying taxis is today announcing a large round of funding to help continue developing its product.

Lilium, a Munich-based startup that is designing and building vertical take-off and landing (VTOL) aircraft with speeds of up to 100 km/h that it plans eventually to run in its own taxi fleet, has closed a funding round of “over” $ 240 million — money that it plans to use to keep developing its aircraft, and to start building manufacturing facilities to produce more of them, for an expected launch date of 2025.

“We’re working to deliver a brand new form of emissions-free transport,” said a spokesperson. “Doing something like that takes significant time and investment, but the outcome is a valuable business and a chance to have a genuinely positive impact on the way we travel.”

This latest investment was an inside round (involving existing, not new, investors) and it closed last month. It was led by Tencent, with participation from other previous backers that included Atomico, Freigeist and LGT. The valuation is not being disclosed, but the company confirms that it is significantly higher than it was in its Series B in 2017. (For some more context, PitchBook estimates that last year the company was valued at around $ 470 million.)

The news today caps off some challenging recent months for the company, even before the Coronavirus took hold of the world and cast a dark shadow on any kind of travel.

Last October, we reported that several sources said that Lilium, which employs 400 people, was looking to raise between $ 400 million and $ 500 million, a round that it had been working on for some months. In the end, the lower amount the company is putting out today is $ 160 million less than the lower end of that range, but from what we’ve been told, this is not far from what the company was actually aiming to raise. Still, that combined with the fact that there are no new investors in the raise might imply some challenges there.

(It is, nevertheless, one of the biggest fundraises to date for a startup in the “flying vehicle” space. (Volocopter, which is also designing a new kind of flying taxi-style vehicle and service, closed a $ 94 million round in February.) Lilium has now raised more than $ 340 million to date.)

“This additional funding underscores the deep confidence our investors have in both our physical product and our business case. We’re very pleased to be able to complete an internal round with them, having benefited greatly from their support and guidance over the past few years,” said Christopher Delbrück, Lilium’s CFO, in a statement. “The new funds will enable us to take big strides towards our shared goal of delivering regional air mobility as early as 2025.”

But raising money has not been the only challenge. At the beginning of this month, the older of Lilium’s two prototypes burst into flames while some maintenance was being carried out. The model was close to being retired, but testing on the second, newer model has nonetheless been paused until the company can determine the cause of the accident with the first aircraft.

“Our second demonstrator aircraft was fortunately undamaged in the fire and will begin flight testing once we’ve understood the cause of the fire in the first aircraft,” a spokesperson said.

The market for aircraft-based taxi services — be they electric, autonomous, or both — is still very nascent. There are no approved aircraft yet on the market (indeed, the regulations for what these would even look like haven’t even been created), and, as a result, there are no services yet in place, either.

But the opportunity of building fast services that could mitigate current traffic congestion, while also reducing carbon emissions, is potentially massive, and so we are seeing a lot of activity and investment from many corners as companies hope their takes on solving that challenge are the ones to hit the mark.

Lilium’s would-be rivals include not just fellow German startup Volocopter, but also Kitty HawkeHang, Joby and Uber, in addition to Blade and Skyryse, air taxi services of sorts that offer more conventional helicopters and other vessels in limited launches for those willing to spend the money.

It’s not clear how much of this will fare in the months and years ahead, in particular at a tricky time for travel and the wider economy. But for now, Lilium’s work so far — it was founded in 2015 by Daniel Wiegand (CEO), Sebastian Born, Matthias Meiner and Patrick Nathen — has been promising enough for its investors to continue backing it for the long haul.

“At Tencent we’re committed to supporting technologies that we believe have the potential to tackle the greatest challenges facing our world,” said David Wallerstein, Chief eXploration Officer at Tencent, in a statement. “Over the last few years we’ve had the opportunity to see the professionalism and dynamism with which Lilium are approaching their mission and we’re honored to be supporting them as they take the next steps on their journey.”


TechCrunch

The U.S. Food and Drug Administration (FDA) is moving much more quickly to grant special ’emergency use authorization’ to equipment and tests that could help increase testing for the novel coronavirus in the U.S., which lags behind most countries in the world when it comes to tests conducted relative to the size of its population. One type of test just approved for use could help expand the availability of frontline testing in hospitals and at clinics where patients are receiving care – without requiring round-tripping to a dedicated diagnostics lab.

Cepheid’s COVID-19 test, which the agency approved this week, also has the advantage of being able to be run either with or without use of a nasal swab, which is key because supplies of nasal swabs are taxed globally in light of the need for testing. It’s also a molecular, PCR-based test, with high rates of accuracy just like the lab-based testing that’s already in place across facilities in the U.S., but it uses the company’s GeneXpert machine (basically a diagnostics kit the size of an inkjet printer cartdrige lab in a box roughly the size of an inkjet printer) to produce results on-site.

Cepheid says that around 23,000 of its GeneXpert micro-labs are already in use around the world, with around 5,000 of those located in the U.S. The company’s hardware has been running tests for the flu for years already, with high reliability rates. The new COVID-19 tests for the system will begin to be shipped out by the Sunnyvale-based molecular diagnostics company starting next week.

Testing in the U.S. has increased over the past week, thanks in large part to widespread efforts to expand availability especially in hard-hit regions like New York State. But the need for more tests is still pressing, as the limits of availability mean that essentially only the most severe cases, often requiring confirmed contact tracing or proof of elevated risk, are being tested. Solutions like Cepheid’s, as well as other potential alternative test methods than can be done entirely at home, like Scanwell’s forthcoming test that looks for antibodies in a person’s blood, are much-needed if we hope to truly expand testing to a degree that it can properly inform any coronavirus mitigation strategy.


TechCrunch

Porsche is squeezing in one more teaser ahead of the global debut of the all-electric Porsche Taycan. And this time, the German automaker didn’t hold back.

Professional racer Shea Holbrook drove a prototype Taycan from a standstill up to 90.58 miles per hour (145 km/h), then slammed on the brakes back to zero all within 10.7 seconds. Shea accelerated the Taycan to 90.58 mph in just 422 feet before braking hard.

If that wasn’t splashy enough, Porsche took it up a level and conducted the demonstration on the flight deck of the USS Hornet, the 27,500-ton aircraft carrier used to recover astronauts from the Apollo 11 and Apollo 12 missions to the moon. You can watch the entire test run in the video below.

Yes, this is gratuitous automotive theater and a marketing ploy. It’s also a spectacularly fun way to show off the stability and performance of Porsche’s big bet on electric vehicles.

Now, the 0-90-0 run falls short of the traditional 0-100-0 tests. It’s not clear why Porsche didn’t make a 0-100-0 run, although available space might have been a factor.porsche taycan uss hornet 001

Stefan Weckbach, vice president of the Taycan product line, admitted that the demonstration was “some kind of fun testing than a completely serious one.” But he added that it was a fitting way to demonstrate the power of the car as it nears the end of its development.

On a tough, changeable surface the Taycan’s composure, its incredible acceleration and stopping power were absolutely impressive – though we decided not to take it to the max, just to reach the 0-100 mph margin.” Weckbach said. While I was completely sure both Shea and the car could achieve something special, I’m really relieved no one went for a swim.”

 

Holbrook said that despite appearances, the deck was quite bumpy.

“Deliberately accelerating towards thin air and the ocean is a new experience for me, but the Taycan gave me a huge amount of confidence — it was really stable but under acceleration and, more importantly, under braking,” she added.

porsche taycan uss hornet 021

 


TechCrunch

SpaceX has completed a second low-altitude test flight of its ‘Starhopper’ demonstration prototype, which is being used to test technologies that will be used to build the full-scale next-generation SpaceX ‘Starship’ spacecraft. This test involved ‘hopping’ the Starhopper (hence the name, get it?) to a height of around 150m (or a little under 500 feet), the highest it’s flown so far, at a SpaceX test facility in Texas. After the hop, which lasted around 50 seconds (the GIF above is sped up 2X) it successfully navigated itself to a target landing pad a short distance away.

This is the second untethered test trip for the Starhopper, and will is intended to be its last, as SpaceX moves forward with construction of its Starship Mk I and Mk II prototypes, which is taking place currently and simultaneously at sites in Florida and Texas. Today’s attempt was the second try after a planned test yesterday was aborted at the last second, with SpaceX resetting and ensuring everything was in place for this longer hop, which lasted just under a minute.

In July, SpaceX ran its first untethered hop, which is designed to test the operation of the Raptor engine SpaceX is developing for Starship, along with other subsystems for use in the production Starship. That flew only for around 22 seconds, and attained a height of just 20 meters (a little over 65 feet).

Construction is currently in progress at both SpaceX’s Texas and Florida facilities on its full-scale Starship prototypes, which SpaceX CEO Elon Musk is ambitious will begin their own flight testing later this year, in perhaps as little as a few months. The larger prototypes, which should be closer to what will actually launch, will test more Raptor engines working together and aim to fly to higher altitudes, another key step as the company works towards a true first orbital test flight.

Ultimately, SpaceX is hoping to replace both Falcon 9 and Falcon Heavy entirely with different configurations of Starship, which will help the company in terms of cost efficiency thanks to its fully reusable nature, and streamlining all of its rocket construction efforts around one type of vehicle.


TechCrunch

SpaceX encountered a snag in an attempted test key to the development of its next-generation Starship spacecraft. Specifically, the StarHopper sub scale demonstration and testing craft it’s using to work on the Starthip’s propulsion system fails to undertake its first untethered test flight at a testing site in Boca Chica Beach in Texas,

The plan was to have the demonstration craft take off and fly to a height of 20 meters before returning to Earth, all under tis own power and directed by its own guidance system. Instead, It seemed to fire rockets and then was engulfed in smoke, before venting fire out of the top of the test craft for a few minutes prior to extinguishing, with StarHopper looking relatively unscathed. We’re still waiting on official confirmation of what happened from SpaceX, but they characterized this as an “abort” on a livestream of the test.

Last week during a static test fire, the StarHopper vehicle was engulfed in a large ball of flame. This wasn’t a planned event, but did not result in significant damage to the spacecraft, SpaceX later said.

StarHopper succeeded in flying its first tethered flight at the beginning of April, and has undergone further testing since then to prepare for this untethered trip. SpaceX CEO Elon Musk said earlier this month that a successful untethered test would pave the way for a full presentation of SpaceX’s Starship spacecraft plans at the end of July, but the test has encountered a few issues since then.

The reason SpaceX and other companies run tests like these is to identify potential issues early in the development process, so it’s good to see them making progress even if that doesn’t mean a “success” in the traditional sense of actually having achieved untethered flight.

SpaceX designed Starship will be fully reusable once complete, unlike Falcon 9 and Falcon Heavy, so it’ll reduce the cost of launches, and the company hopes to eventually use it to fly all its missions, though it’ll keep Falcon 9 and Falcon Heavy in service for its paying customers as long as there’s appetite.


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