As talk increases of the extensive virus and antibody testing that will be required before businesses can reopen, it is becoming apparent that the MDx testing apparatus of most countries are currently or will shortly be overwhelmed for an extended period. This is a certainty the same way the the hospitals are now being overwhelmed. IVD tests that can be performed on site will be in high demand. The USFDA has approved a an emergency use lab test that can be used to test for antibodies. However, to date, widespread serology testing for these antibodies are not available and no approved fast TAT POC test exists. As such, it is likely that MDx labs will remain under tremendous pressure to complete the volume of infectious disease assays and serology assays that this pandemic will require.
As I have discussed on several occasions, inertia is likely one of the main impediments (outside of diagnostic regulatory approvals in the US, China and Japan) that BCART is struggling to overcome in ramping the adoption of Idylla. Labs and testing facilities have staff trained and facilities that are set up to perform pyro-sequencing, Sanger Sequencing, etc. or NGS. While they may like the ease of use, the fast TAT, the reduction in manpower, and the ability to resolve failures that are inherent in the Idylla system, they have difficulty overcoming the friction in changing existing oncology MDx processes. I wonder if the recent increased Idylla usage observed in Scandinavia that was mentioned by Verrest might be a precursor of things to come. All countries will be looking for ways to improve work flow in order to deal with the greatly increased volume of infectious disease tests. I suspect that the average 2 to 3 week TAT for cancer MDx testing (referenced in many BCART power points) has now become much longer, maybe months. This may acceptable during the emergency situation created by the initial phase of the pandemic. I doubt that it will be an acceptable as the pandemic continues for many months. As in Scandinavian countries, I can see this dynamic becoming a driving force for overhauling testing procedures to become more efficient and less labor intensive. This may provide a strong incentive to disrupt the inertia through the adoption of Idylla and/or other labor saving MDx systems. In the current environment, this discussion is most pertinent to the EU where Idylla has many assays are approved for diagnostic use. It will also be interesting whether this becomes a force to accelerate diagnostic use approvals (emergency or PMA, 510K) in other geographies.
I suspect that the 1st Qtr update will include additional discussion of this dynamic.
Best wishes to all for Happy and Safe Easter and Passover.
FL