Grant project aims
Research and development priorities
Nine areas of work stand between the platform concept and evidence a regulator or a clinician could rely on. Each one is written here as a research aim, with the open questions we would like a partner to help answer.
The nine priorities
Priorities are grouped by topic. Several run in parallel, and the validation work depends on the earlier assay and reader work.
Biomarker and antibody research
Select cancer-associated protein biomarkers with a credible clinical question behind them, and antibody pairs with the affinity and specificity a sandwich immunoassay needs. Open question: which markers justify the first assays.
Assay optimization
Membranes, conjugates, buffers, flow control and line chemistry, tuned for signal, background and reproducibility. Open question: which design choices drive variability most.
Multiplex detection
Measuring more than one biomarker on a strip without cross-talk. Open question: how many analytes can be read before precision degrades.
Digital reader development
Optics, sensors, firmware and calibration for a portable fluorescence reader. Open question: what calibration scheme holds across devices and lots.
AI-assisted signal analysis
Software that converts raw signal into a quantified result with a confidence measure. Open question: does a learned model outperform a fixed algorithm on held-out data.
Analytical validation
Limit of detection, precision, linearity, interference, cross-reactivity, hook effect and stability, under written protocols based on recognized consensus guidelines such as the CLSI evaluation protocols.
Clinical research and feasibility
Specimen studies under IRB oversight to learn how results compare with reference methods in the intended-use population.
Manufacturing and quality
Process controls, lot release criteria and design and development documentation. Open question: which process parameters must be locked before validation lots are made.
Regulatory readiness
Intended use, risk analysis and the evidence plan to discuss with regulators before any pivotal work.
How priorities become fundable aims
A grant reviewer needs to see a hypothesis, a method, a success criterion and a team that can deliver. For each priority we draft one or more specific aims in that form, then look for the partner whose expertise makes the aim credible.
For example, an analytical validation aim becomes fundable when a laboratory with documented experience in immunoassay validation is named to run the precision and interference studies, and a biostatistician has set the acceptance criteria in advance. The partner roles page lists the open roles, and the grant programs page shows which funders support which stage.
What we will not claim ahead of the data
The program follows one rule: develop the technology, generate the data, validate the performance, then make the claim. Until analytical and clinical studies are complete, we do not describe sensitivity, specificity, time to result or clinical benefit for any OncoFirm assay. A longer discussion of why that discipline matters for multi-biomarker tests is in our research framework summary on AI multi-biomarker blood tests.
Frequently asked questions
Which cancer types or biomarkers come first?
Target selection is part of the first aim and will be discussed with prospective partners under confidentiality.
Can a partner propose a new aim?
Yes. If your expertise opens a research question that fits the platform, describe it in a collaboration inquiry.
Which guidelines will validation follow?
Protocols will be based on recognized consensus guidelines for in vitro diagnostic evaluation and agreed with the partner laboratory and study statistician before work begins.
See an aim your group could lead?
Tell us which priority matches your work and what you would need to take it on.
Research and regulatory status
OncoFirm™ technologies described on this site are in research and development. Their performance characteristics have not been established, and no OncoFirm product has been cleared, approved or authorized by the U.S. Food and Drug Administration. Nothing here is medical advice. Reference to a federal agency or funding program does not imply endorsement, funding, sponsorship or affiliation.