I caught up by teleconference recently with Countable Labs CEO Giovanna Prout, fresh off Countable Labs' $26M equity fundraising - a round which was oversubscribed. Top on my agenda: what is Prout's vision to turn that money into products. And how will Countable balance building molecular tools vs. applying those tools to clinical problems?
Prout sees the biggest opportunities for Countable Labs in the clinical space, particularly cell and gene therapy and biopharma. Countable Labs' 10-color digital PCR approach, which according to Prout can be driven by much longer amplicons than in competing digital PCR platform, has numerous applications in this space. Countable Labs has developed a 1-step cDNA workflow, simplifying operation. For viral gene therapy vectors, multi-kilobase amplicons can give more information on genome integrity. In oncology settings, long PCRs enable designing amplicons that capture higher fractions of fused transcripts in cDNA, as they can be less sensitive to specific placement of breakpoints.
Countable Labs is still open to a number of go-to-market strategies for their tests - they will partner with biopharma on clinical trials or with large academic or reference labs with Countable PCR technology being used in a Lab Designed Test (LDT), but Prout said that should Countable Labs discover a "killer app" they would have the option of building out their own CLIA lab. Their instrument has UL/CE certification and will be on a path to 510(k) clearance. They also are planning to meet ISO-13485 and are fit for GMP settings, with design history files documenting the revisions of the various assay schemes.
We both agreed that the Minimal Residual Disease (MRD) market is growing rapidly, with many players. Prout cites the low capital cost, low test cost, and ease of result interpretation - no bioinformatics needed (which is a bit of a bittersweet point for me!) - as key advantages of Countable PCR over methods relying on NGS. That means Countable PCR could potentially be placed in more diagnostic labs due to the low capital cost, and with a lower cost per test it might be possible to run the MRD tests on a patient more frequently. Of course, that gets into the morass of medical payer systems, but it could make sense for them if earlier recognition of a relapse avoids costly procedures. From the patient point of view it is a clearer win - beat a cancer back down before it gets very far.
Countable Labs isn't giving up their tools business, but Prout sees the financing - remarkable in these challenging times for biotech in general and particularly the molecular tools segment - as an opportunity to quickly advance products which make significant positive impacts to patient care.
After I drafted this, Countable Labs and Promega announced a joint marketing agreement for Countable Labs' systems with Promega's Maxwell nucleic acid purification platform.
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