Coronavirus Testing & Startups

Photo by Adam Wilson on Unsplash

As the world scrambles to grapple with the coronavirus pandemic, startups are stepping up their game. Startup companies are unique because they thrive on solving big problems, and have the ability to move very quickly.

This whole corona situation offers an ideal opportunity to demonstrate our collective social responsibility. We all want this social distancing phase of our lives to be behind us for our own sake, but understand that the only way to make that happen is by helping the whole.

A great example of this is how AppsFlyer CEO Oren Kaniel has dedicated $500K toward testing innovation. The goal is to support home testing solutions, which don’t require going to a healthcare facility.

‘We will dedicate a $500,000 fund for testing innovations, as well as other support such as leveraging our cloud computing and engineering If you are in the testing innovation field and have a viable testing solution for COVID-19, please contact us at covid19@appsflyer.com.” Oren Kaniel

Genealogy company MyHeritage is recruiting 150 employees for its expedited coronavirus (Covid-19) testing lab in Israel. MyHeritage has partnered with genome sequencing company Beijing Institute of Genomics (BGI) to set up the lab. The lab, expected to begin operations by April 9, will be able to conduct 10,000 tests per day, but expects to scale up to 20,000 per day. Within two weeks, Israel is expected to conduct 30,000 tests a day, including the ones done at MyHeritage’s lab, Israel’s Ministry of Health announced.

Some companies are currently working on developing COVID-19 tests to not only provide to health centers but eventually deliver directly to consumers. Beyond just a convenience factor, the hope is that by making coronavirus home test kits available, people can take measures to help slow the spread of the virus while still getting tested.

In fact, health experts are also on board for home coronavirus testing in the U.S. In a recent paper published in JAMA Health Forum, two doctors laid out the possible benefits of making these at-home tests available. An at-home testing system could mean more people could get tested at a lower cost, including people who might live far from a health center, the doctors argued in their paper. Plus, if people have the option of testing at home, they won’t have to venture to the hospital and potentially expose people to COVID-19 while they’re out, according to the paper. Coronavirus home tests could also help relieve the burden placed on hospitals amid the coronavirus pandemic, as many health centers have been overwhelmed by the rapidly-increasing COVID-19 cases, the doctors wrote. (Shape)

The startup incubator YCombinator is currently offering funding to startups that are trying to address the pandemic. Here are some Testing & Diagnostic solutions worth noting:

UnimaRapid low-cost test for COVID-19

Find™ COVID19 is a screening and triage test for patients suspected of being infected with the SARS-CoV2 virus. It’s an ultra-low-cost test that just uses a paper strip and a smartphone, no lab equipment required. In clinical trials now, launching in May. Customers lined up in Indonesia, Paraguay, Chile, Colombia, and Peru.

How you can help: FDA emergency use authorization / Virus-like particles with spike protein for test validation / Funding to accelerate product launch

Synkrino BiotherapeuticsRapid Field Test for COVID-19

Synkrino Biotherapeutics is building a rapid, portable field test for the RNA virus 2019-nCoV/COVID-19, adapting our existing lab and analytic protocols for the rapid detection of this RNA virus.

This rapid screening system will be launched for community public health screening in order to —

  1. Determine the community prevalence of 2019-nCoV/COVID-19 infection (focus on asymptomatic and mildly symptomatic). The prevalence is currently unknown.
  2. The rapid, portable field test is being built to rapidly screen and clear populations prior to re-entering work, school and other institutions. Referring others to confirmatory testing, and into care.

How you can help: We are seeking funding partners for this project. We are also seeking help with sourcing of key reagents for the rapid implementation and scale-up. This includes RNA isolation, and other items.

BillionToOneBetter and high-throughput testing for COVID-19 using existing devices

BillionToOne has repurposed their technology currently used for prenatal genetic tests to create a new test for COVID-19. The BillionToOne test uses Sanger sequencing, the devices that are already widespread. They will publish a COVID-19 diagnostic that other labs can use to unlock >1,000,000 tests per day capacity.

How you can help: They are looking for contract kit manufacturing of primers, oligos, RNA spike-ins etc. OR (preferably) introduction to a large partner, e.g., Thermo Fisher, that may want to take over EUA process + kit manufacturing for faster and wider distribution. Also, introductions to other testing laboratories such as Quest, LabCorp, BioReference can accelerate the distribution.

Luminostics — Smartphone-based point-of-care test for SARS-CoV-2 infection and COVID-19 immunity

We’re developing, towards FDA EUA, a 15-minute point-of-care test for the simultaneous detection of SARS-CoV-2 virus from respiratory samples (to diagnose active COVID-19 infection) and anti-SARS-CoV-2 IgG/IgM antibodies from finger-stick blood (to test for COVID-19 immunity).

Our diagnostic platform enables orders-of-magnitude lower limits of detection compared to visual-readout strip tests — and therefore higher clinical sensitivities — using only a smartphone’s optics paired with an inexpensive adapter and app for readout. This sensitivity enhancement is expected to result in our rapid test approach RT-PCR’s accuracy for virus detection and match lab-based ELISAs’ accuracy for serology.

As the pandemic evolves or, worse, returns in a second wave later this year, we think our rapid duplex test for the virus and immunity will be a critical tool in the fight against COVID-19. This project’s timeline to FDA EUA is ~3 months from when it is fully funded. We intend to later seek FDA approval for home use of this test, perhaps in combination with our in-development product for at-home flu testing.

What we need:

  • Funding to support assay development, launch, and scale-up
  • Access to inactivated whole virus for use in BSL-2 assay development and/or native purified SARS-CoV-2 antigens
  • High-affinity antibodies specific for CoV-2 antigens for consideration as diagnostic reagents in addition to our current sources

Everlywell, is a home testing startup adding a COVID-19 test to its offering. It says on their site that COVID-19 tests are not yet available for individuals. Given the slow roll out of testing for COVID-19 in the U.S., and concerns about spreading the disease, at-home testing could help to diagnose more cases. After initially limiting testing to one provided by the Centers for Disease Control and conducted at state and local public health labs, the Food and Drug Administration allowed certified labs, including commercial lab testing companies, to develop and distribute COVID-19 tests on Feb. 29. Though other private companies have been involved with creating tests for COVID-19, this is the first company to offer its test directly to consumers. (TIME Magazine)

Now this is where things get interesting:

Everlywell says it is ready to ship 30,000 COVID-19 tests, and plans to expand the number of labs processing the samples. But CEO and founder Julia Cheek says that scaling up the number of testing kits will depend on the availability of swabs for collecting samples. Three major manufacturers make the swabs, but the main producer, it turns out, is a company based in Italy. Because the country is under lockdown, limited supplies from there, as well as the surge in demand as more COVID-19 testing is conducted around the world, are leading to a global shortage of swabs for any lab performing the test. That’s why Everlywell’s first kits will contain only one swab, and Everlywell will limit kits to one per household until the supply of swabs becomes more plentiful. (TIME Magazine)

All this came to a halt when the Food and Drug Administration updated its diagnostic testing guidelines for SARS-CoV-2 on Saturday to expressly note that it has not yet authorized at-home testing. A spokesperson for Everlywell told VICE that the company is “still committed to making a COVID-19 test available to consumers who fall within the CDC’s guidelines for recommended testing and are actively working with the FDA on a path forward for COVID-19 sample self-collection in a home setting.”

Everlywell has also announced a $1M COVID-19 Development Incentive Program for home collection testing. They issued a call-to-action and will award a pool of up to $1M in development incentives for selected labs that can meet their criteria and provide distribution to Everlywell.

Two high-profile San Francisco health start-ups began marketing at-home coronavirus kits that let people collect their own saliva samples or oral throat swabs and then send the specimens to commercial labs to be tested for the virus. The start-ups, Carbon Health and Nurx, each said they were preparing to offer thousands of the kits in the coming weeks. But when the Food and Drug Administration issued an alert warning consumers that it had “not authorized any test” for the coronavirus that people could buy and administer at home. Carbon Health and Nurx subsequently suspended sales of their kits. (NY Times)

Carbon Health is optimistic. “We remain hopeful that the FDA will approve at-home sample collection as one of the tools to address this pandemic,” company co-founder and medical director Caesar Djavaherian, MD, said in a March 22 blog post. Meanwhile, the company is still providing telemedicine services for people with Covid-19 symptoms. (Elemental)

At-home diagnostics startup Scanwell, which produces smartphone-based testing for UTIs, is working on getting at-home testing for the novel coronavirus into the hands of U.S. residents. The technology, which was developed by Chinese diagnostic technology company INNOVITA and has already been approved by China’s equivalent of the FDA and used by “millions” in China, can be taken at home in 15 minutes with the guidance of a medical professional via telehealth, and produces results in just hours. …. Scanwell’s test will require FDA clearance, but the company tells me that it’s in the process of securing approval through the FDA’s accelerated emergency certification program. (TechCrunch)

Founder of the Good Vibe Agency