a lot to adMIRe (Market/FDA/Reiumb)The flood of sero test on the market has created a false expectation of “rapid diagnosis”. FDA is working relentlessly to defunct sero tests (has pulled ~31 Tests from market; de-listed 35 comp in the last few weeks) from comp that failed to estb validation data. So far ~200 sero test kits being distributed in US. Under the recently tightened guidance for serology testing, the FDA set more stringent requirements for performance and is encouraging all serology test providers to submit for emergency use authorization
In terms of Reimbursement – CMS released rates for codes 86328 @ $45.23/test (covering point-of-care Qualitative or semi qual tests such as MedMira’s) & 86769 for multi-step lab-based @42.13/test
Mkt for Sero Test – this is of course oversimplification as mkt is largely unproven given its infancy and could ultimately end up on the larger side if immune protection from the antibodies was not as durable and thus these tests could be required annually – making it a large market longer-term.
The market size and price per test will vary across countries but lets say if Medmira gets EUA then largely focus will be in US (given estb CPT codes & FDA stance of estb stringency). Reasons for taking tests mainly being - “Getting workforce back to work” Assay, Identifying recovered patients for convalescent plasma & potential confirmation of vaccine efficacy in the longer term.
Using price/test estimate approx. for $45 lateral/vertical flow strip test. We also know that RT-PCR tests are more restricted to symptomatic patients and their close contacts, so there is a huge unpenetrated market that can be exploit using sero test. So, if 20% of Americans get sero testing ~65M people & in order to increase sensitivity/specificity an individual needs to take it twice then market opp comes out to be ~$5.8B. Now, comp that are EUA approved (~25 companies) will take large chunk of this market perhaps 50%-60% which comes out to be $3.2B. Again this is US market and usually EU is ~1.5-2.5X of what is US.