As we worked through the project, it was not only an engineering firm developing an instrument, but it was a consultancy, as well, that allowed us to do it properly to make sure that the CLIA-certified laboratory was happy with the LDT that was developed at the lab.
We also envision the use of these instruments going through 510(k) approval to be sold to external laboratories, academic institutions, or large GI practices, so they can use them outside of our CLIA lab post-510(k).
And we know that StarFish has the capabilities to help us through that journey.
Matt Mitcho
Founder, CEO
Gemelli Biotech
