Diagnostics Companies
Menu expansion without adding R&D headcount
From assay concept to a manufacturable, registrable kit - and then we manufacture it. Development cost can be offset against committed volume.
What we hear
What we hear from diagnostics R&D and commercial leaders
- Menu expansion pressure against fixed internal development capacity
- A competitor launch that has to be answered in twelve months
- Regulatory documentation workload that consumes the team for every new product
- Manufacturing capacity that constrains launches at exactly the wrong moment
What we do about it
One workstream, one accountable lead
We run the whole path: assay development → analytical validation → kit design and design transfer → manufacturing supply. One agreement, one team, one set of documentation that carries through to the regulator.
Typical investment
Product programmes run USD 100K–900K. Development is frequently structured as a phased milestone fee offset against committed manufacturing volume, which lowers the cash cost of the development phase considerably.
Why companies choose us over a larger supplier
Global manufacturers are excellent at their own platforms and inflexible about yours. We build to your specification, put your brand on it, and give you the documentation to register it in the territories you actually sell in.
Proof
What it looks like in practice
A five-target respiratory multiplex validated to 50 copies per reaction, taken through kit design and pilot lots with a complete registration dossier, in nine months - followed by an ongoing supply agreement.
Representative programme - illustrates typical scope and outcomes; not an individual client account. Client-specific references are available on request under confidentiality.
Enterprise AI for Life Sciences
Ready to Advance Your Drug Discovery Pipeline?
Partner with Prognica Labs to leverage enterprise-grade AI, computational chemistry, and molecular simulation technologies that accelerate discovery, reduce development risk, and improve R&D productivity.
From biotech startups to global pharmaceutical organizations, we help research teams make faster, evidence-driven decisions across every stage of early drug discovery.