0) From a clinical perspective this is data we are generating on an on going basis. Analytically this is a largely a function of the characteristics of the affinity, specificity of the capture molecule used to capture the target (viral particle). As you point out EUA gives opportunities to launch sooner... But it's still critical to validate technogies both internally and externally probably to a greater extent than the de minimus EUA reqs
1) great question. Our approach is novel which allows us to tap into new supply chains that are inherently more scalable (think semi-conductor Fab) but the trade off is execution risk.
Thanks for your reply! Makes sense with regards to the specificity and sensitivity. Are those more scalable supply chains ones that expose you to risk with international suppliers? My understanding, at least from what we've been hearing from our governor's press conferences (so take it with a big political grain of salt obviously), is that while we have high throughput machines capable of large numbers of tests, the reagent supply chains all go back to china leaving domestic companires reliant on international trade negotiations to be able to get the inputs they need to scale. Is that a valid type of concern and are there concerns that even if it's technologically easily scalable, the political and operational logistics of relying on third parties with different incentives could negate that advantage? I don't knwo how valid a concern that is, but that's the narrative we keep hearing here.
I think we're up against many of the same challenges everyone else (Roche, Abbott, et al.) is up against. At the end of the day if we could all wave a magic wand and fix supply chains we would. Technically, we (the collective diagnostics hive-mind) know how to detect viruses. We haven't yet figured out how to deploy these technologies on scales orders of magnitude above our baseline implementations.
How is chip fabrication is more scalable than plastic 384-well plates and cotton swabs? Nothing shy of a home pregnancy test is more scalable than qPCR.
This is one of the implementations we're actually developing. One of the challenges with the implementation of testing on this scale is not necessarily on the technology/assay but on implementation. How do you reasonably test millions of folks each and every day, or said another way actually get millions of nasal swabs, saliva, etc on 384 well plate?
I think our ultimate approach is much more akin, albeit with a bit more sensor voodoo magic, to a at home pregnancy test than 384-well plate qPCR tests at central labs.
OK well, having used a Biacore perhaps two decades ago, I'll just have to imagine your "magic" must be pretty good to compete with plastic multiwell plates and cotton on a stick.
50 or 100 sites, each with say a few dozen liquid handling robots. Let’s say each site runs 200 plates per day.. doesn’t seem unreasonable. The only hard parts are the funding and regulatory requirements.
You're getting downvoted but I think it's a fair question actually. I'd assumed they were referring to tapping into non-stressed supply chains. What you mention is valid though and something I'm curious about as well. Are the consumables reliant on chip fabrication? I don't think PCR machines themselves are scalable, maybe chips are more scalable than the optics systems for qPCR, but a valid point about whether the consumables are more scalable as well.
1) great question. Our approach is novel which allows us to tap into new supply chains that are inherently more scalable (think semi-conductor Fab) but the trade off is execution risk.