My son works at a company called Homodeus. It’s part of 4Catalyzer, an umbrella of seven medical biotechnology companies with a staff of 300 scientists and engineers. One of the Homodeus products, still waiting FDA guidance is a COVID-19, RNA self-tester called Homodeus Detect. It tests for COVID RNA directly, not for antibodies, with tests are much faster than hospital tests, taking 45 minutes, but more complex than the unreliable test strips. So far, the Detect tests have shown no false positives or false negatives. That would suggest 100% reliable, except but there are a fair number of invalid tests. The invalid tests are lares due to the complexity, and also to the fact that you are testing snot, essentially. There is no blood-taking involved, unlike with the test strips, but just a nasal swab, and the cost is moderate, about $35 per test. However you have to do some lab work. After you swab your nose, you put the swab in a heated liquid bath where chemicals break up the snot and dissolve the shells on any viruses or pollen present. After 30 minutes, you pass the liquid onto a detector strip that contains a conjugate protein that binds to SARS-CoV-2 RNA. Your answer appears 15 minutes later as one of three lines: one for positive, one for negative, or one indicating an invalid test. Invalid tests show up more often than they like, about half the time, especially when the test is done by amateurs.
Getting an invalid test result is a downside of the current product, but I don’t think it should prevent sales. You get better at doing the test, and speed and lack of false positives and negatives is a bigger plus. It seems worthwhile to fast-track offer this test for doctors offices and hospital admissions, at least. I’d also like to see it used for airplane boarding and interstate travel, so that a person traveling might avoid the two week quarantine that many states impose. I’d certainly pay $200 or more to avoid a two-week quarantine, and if I have to do a second or third test, I’d do that too.
Because this test measures virus RNA, and not antibodies, it indicates infection virtually as soon as you’re infected. That’s a benefit for those wishing to fly, or to meet with people, an advantage that is not lost on Elon Musk at least (see tweet). The test also shows negative as soon as the virus is gone, and that’s big. In recent months the FDA has fast-track approved an antibody indicating test from Abbott Labs, but that test has many false readings and only indicates infection several days afterward, and it does not indicate when you are no longer infectious.
The FDA has not offered to fast track this test, or any other like it for approval. They have not even indicated what sort of reporting and privacy requirements they want, so things sit in limbo, both for Homodeus, and for competing companies. Here is a story in USA today: https://www.usatoday.com/story/news/2020/07/29/fda-opens-door-rapid-home-covid-19-tests/5536528002. One big issue that the FDA is contact tracing. The FDA would like to be able to trace all the contacts of anyone who tests positive, while maintaining privacy as demanded by the 4th Amendment.
One way around the 4th amendment concerns would be to require anyone who uses the test to sign a waiver allowing the government to trace their contacts. Alternately there could be a block-chain enabled app that would come with the test. An app coms already providing a timer for when to move to the next step, and it includes a machine-vision system to help analyze dim lines on the indicator. Perhaps the FDA would accept block chain as a way to allow full reporting while maintaining privacy The FDA has yet to provide guidance on what they want, though. Without guidance or fast-track approval, things sit in limbo. Here is a scathing legal analysis from the Yale Law Journal.
You can get a free test, but have to do it at Homodeus headquarters in Guilford, Connecticut. It’s free, and results appears in about 45 minutes.. Homodeus has been manufacturing the test in quantity; if you are interested, use the following link to sign up: https://www.homodeusinc.com/research. Healthcare providers are particularly welcome.
Why did the FDA fast-track approve Abott’s antigen/ antibody test. Maybe because the tests rethought to not lead to lower mask use. Alternately, Abott has more political pull. You can read the FDA’s explanation here. In my biassed opinion the Homodeus product is good enough to fast track especially for hospitals and healthcare providers. It could save lives while allowing the economy to reopen.
Robert Buxbaum, November 15, 2020 (with massive help from Aaron M. Buxbaum)
