Like the other longs, I'm anxious to see progress accelerate. Covid threw a huge monkey wrench into the projections and the growth trajectory that was to begin in 2020. I had a couple observations from the earnings release and from other recent events:
Immunexpress filed with the FDA for Septicyte Rapid 510K approval in December. Dr Roy Moore from Immunexpress gave a webinar to the Society of Critical Care workers earlier today. Unlike the September presentation, there were a fair number of questions, which I attribute to increased interest, They are requesting approval for Septicyte Rapid to be used as part of a panel of indicators (with CRP and PCT). They are de-emphasizing COVID Triage. The whisker plots from on-going Covid studies do not appear to show a clear cut relationship.
I'm also encouraged that BCART is filing with the FDA for MSI approval in the 2nd quarter. I had previously been expecting 3rd or 4th quarters. As I have said before, I tend not to dwell on the cartridge growth rate since the Idylla content is only approved for RUO use in the three largest markets. Without diagnostic use approval, Idylla is being excluded from 90% of the market and most importantly from the intended POC market. I expect a larger inflection in sales when BCART is able to sell into the intended market and is reimbursed by insurance.
In addition to the need for expanded diagnostic approval, I think rapid uptake of Idylla will also require a content killer application that really drives demand. I've been disappointed on this front by the Oncotype Dx, termination and the septicyte Rapid Covid Triage delays. EGFR has considerable potential, especially in Asia, however recent papers suggest that the assay has reduced sensitivity for a critical mutation T790M, However, the BCART EGFR-BRAF assay to be released next year will include improved sensitivity for this mutation. I'm happy that BCART is already working to address this issue since the mutation is specifically targeted by currently marketed TKI drugs. The timing of the improved assay will undoubtedly help with the Asia launches.
I've resigned myself to the concession that my investment in BCART was way too early. We are only in the 1st inning of the Oncology MDx revolution that is driving personalized medicine, I believe the attributes of Idylla will make it successful. However, it is hard to disrupt a testing regime when so many physicians still have not included MDx in their routine decision making. The pandemic certainly set progress back on this front. The pivot to infectious disease showcases the versatility of Idylla. However, many of the consoles may end up at locations that will not drive BCARTs mainstay oncology products. I think this slight disadvantage will be offset by higher oncology volumes in the 2nd half of 2021 and into 2022.
I know these random thoughts are a bit disjointed.
Got to go,