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Comment by WoodenChair | Hacker News Reader

Is there a possibility of us getting an FDA sanctioned OTC antibody test in the near future so we can find out if we already had the virus?

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We are working on this. I can’t share more here but if you are interested and want to help, let me know how at zen[at]rapidcov[dot]com (dev, design, marketing, medical, partnerships, etc). We have our core team in place but we are planning to be bring on more people in the next few weeks.

P.S. ignore the website, it’s not the product.

What would make you different from the many many EUA antibody tests already on the market? How are you going to get yours approved for OTC at-home use?

Originally, we tried to bring the existing antibody tests that can only be sold to medical practitioners. During that process, we engaged in conversations with the FDA to get approval and we asked them what their concerns are with at-home antibody test kits. Once they explained us, we went back to the drawing board and worked on a solution that would allow us to mitigate the FDA’s concerns.

We then proceeded to present our solution to the FDA. They were positive so we filed for our pre-EUA and now we are working with an FDA reviewer.

I’m not going to pretend that our solution will end being approved. I have no idea since none of us (the three founders) have medical device experience. Nonetheless, we are willing to take a huge risk in terms of money and time, and at least know at the end that we gave it our best shot.

I'm guessing you've already seen this, but in case you haven't: https://newsroom.questdiagnostics.com/2020-04-28-Quest-Diagn...

Quest is now selling a consumer initiated antibody test. It's not at home, of course.

Thanks for taking risks to try and make a difference. I hope you are successful! These tests are pretty simple to administer so there really should be an at-home version.

This is really the direction we need to go. If there was a cheap and quick test, you could monitor your population over time. Relax restrictions with testing prior to restarting activities.

It would go a long way in managing the epidemic while reducing the impact on the economy.

I'm sure it will come, but it looks like the FDA is waiting until the big companies ask for an EUA because they don't trust the startups (or the startups aren't able to do what LabCorp does?)

There's one available in Richmond, CA for $125: https://www.sfgate.com/bayarea/article/COVID-19-antibody-tes...

While this is walk in, the actual test likely requires an NPI number. There's likely a physician (or mid-level that can prescribe - don't know CA law) that's pretty much there to "check the boxes".

It's $199 (+taxes).

It literally says $125 in the opening paragraph of the article I linked. Do you have updated information?

Yes, the lab itself. https://app.acuityscheduling.com/schedule.php?owner=19381748

That seems very odd considering the SFGate article was published yesterday, and I presume they asked the lab how much it costs. I sent the lab an email to clarify. Let's see what they send back.

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