Platform / Partnerships / Clinical collaborations
Pillar guide · Clinical collaborations
Clinical Collaborations to Advance Early Cancer Diagnostics
OncoFirm™ is moving its fluorescent lateral flow platform from feasibility toward analytical and clinical validation, starting with quantitative CEA and PSA tests. That step depends on partners: clinicians, laboratories and research teams who can supply well-characterized specimens, run comparison studies and help define where a point-of-care cancer biomarker test fits in patient care.
At a glance
Lead programs
Quantitative CEA (lead) and PSA (second) on one handheld reader
Seeking now
Characterized specimen sets and method-comparison sites
Seeking next
Clinical evaluation, point-of-care usability and AI research partners
Laboratory
Broad Hollow Bioscience Park, Farmingdale, NY
Status
In development · not FDA cleared or approved · research use only
On this page
Why now
Why clinical collaboration matters at this stage
A clinical research collaboration is a structured partnership in which a diagnostics developer and a clinical or laboratory team share specimens, expertise and data to test whether a new assay measures what it should, in the people it is meant for.
Most promising cancer biomarkers never reach routine care, often because they were never validated with the right specimens, comparators and patient groups. Building that evidence early and openly is the most reliable way to turn a good measurement into a useful test.
For OncoFirm, the platform design is in place: a self-calibrating fluorescent strip with a reference line on every test, read by a handheld fluorescence reader. The next questions can only be answered with partners: how closely results track laboratory methods, how they behave across real patient samples, and how a ten-minute quantitative result changes clinical workflow.
What we need
Current collaboration priorities
Priorities follow the development stage of the lead programs. If your work fits any of these, we would like to hear from you.
Characterized specimen sets
Banked serum and plasma with laboratory CEA and PSA values, clinical annotation and consent for research use, spanning the designed measuring ranges.
Method-comparison sites
Laboratories able to test the same samples on OncoFirm prototypes and an established laboratory immunoassay, following CLSI method-comparison practice.
Clinical evaluation sites
Oncology, colorectal surveillance and urology teams to study serial CEA and PSA measurement in the intended-use population.
Point-of-care usability
Clinics and community health settings to assess training, workflow and result reporting where a lab is not close by.
Data science and AI
Groups working on signal analysis, quality control and trend support for AI-assisted diagnostics.
Manufacturing and distribution
Partners for scale-up, quality systems and access, including for the wider assay pipeline.
Study pathway
How a collaboration moves a test through development
Each stage produces evidence the next one depends on. Partners can join at the stage that matches their strengths.
01
Feasibility
Antibody pairs, fluorescent conjugates and strip layout are tested against the target.
Partners contribute
Specimen access, assay know-how
02
Analytical validation
Precision, linearity, detection limits, interference and lot-to-lot consistency on the reader.
Partners contribute
Characterized specimens, comparison testing
03
Clinical evaluation
Performance in the intended-use population, with serial measurements where they matter.
Partners contribute
Clinical sites, study design, biostatistics
04
Regulatory and launch
Quality-system documentation and submissions, then manufacturing and distribution.
Partners contribute
Regulatory, manufacturing and channel partners
Who we work with
Partners across research, care and industry
Academic medical centers
Biomarker science, specimen biobanks and investigator-initiated studies, with co-authored publications.
Hospitals and health systems
Clinical evaluation and real-world workflow studies in oncology, urology and primary care.
Reference and hospital laboratories
Method comparison, precision and interference testing against established immunoassays.
Contract research organizations
Multi-site study management, monitoring and data management to GCP standards.
Biotech and pharma
Biomarker monitoring alongside therapy programs and decentralized trial sample testing.
Government, nonprofit and global health
Early-detection programs and access in settings with limited laboratory capacity.
Collaboration models
Ways to work together
Collaboration model
What it typically involves
Specimen and data sharing
De-identified samples and reference results under material transfer and data use agreements
Technology evaluation
Research-use prototype strips, reader and protocols evaluated in your laboratory
Sponsored research
A defined study funded by OncoFirm and run by your investigators
Joint development
Shared work on a new assay, panel or software feature, with IP terms agreed up front
Joint grant applications
Co-applications to public funding programs, such as NIH SBIR and STTR
Licensing and commercial
Manufacturing, distribution or technology licensing once products are validated
Scope, budget, intellectual property and publication terms are set out in a written agreement before any study starts.
Study standards
How collaborative studies are run
- Ethics and consent. IRB or ethics committee approval, with informed consent or an approved waiver for banked specimens.
- Good Clinical Practice. Clinical studies follow ICH E6 GCP principles for protocol, monitoring and records.
- Analytical methods. Precision, linearity, interference, detection capability and method comparison follow the relevant CLSI guidelines (EP05, EP06, EP07, EP17 and EP09).
- Privacy. De-identified data, HIPAA-compliant handling, access controls and data use agreements.
- Transparent reporting. Diagnostic accuracy studies are planned to follow STARD 2015, with results published whether positive or not.
- Traceable calibration. CEA and PSA calibration is planned to trace to WHO reference materials (NIBSC 73/601 and 17/100).
Our laboratory
Research in New York
OncoFirm’s laboratory is at Broad Hollow Bioscience Park, 3 Bioscience Park Drive, on the campus of Farmingdale State College in Farmingdale, NY. Corporate offices are in Port Washington, NY. The location makes it practical to work closely with academic, hospital and laboratory partners across Long Island and the New York metropolitan area, and we collaborate with partners anywhere.
FAQ
Frequently asked questions
Who can collaborate with OncoFirm?
Academic medical centers, hospitals and health systems, reference and hospital laboratories, contract research organizations, biotechnology and pharmaceutical companies, and government, nonprofit and global health programs.
What does OncoFirm need from partners right now?
For the CEA and PSA programs we are looking for well-characterized serum and plasma specimen sets with laboratory reference values, and sites able to run method-comparison studies against established laboratory immunoassays.
Can my institution evaluate the reader and strips in our own lab?
Yes, through a technology evaluation agreement once research-use-only prototypes are available. OncoFirm provides strips, a reader and protocols; results are shared under agreed data and publication terms.
How are patient samples and data protected?
Studies run under IRB or ethics committee approval with informed consent or an approved waiver. Specimens and data are de-identified and shared under material transfer and data use agreements that follow HIPAA requirements.
Will collaborators be able to publish?
Yes. Publication rights, authorship and timelines are agreed at the start, and diagnostic accuracy studies are planned to follow the STARD reporting guideline.
Does a collaboration mean the test is approved or for sale?
No. OncoFirm assays and the reader are in development, are not cleared or approved by the FDA, and are not available for sale. Collaborations generate the evidence needed before any regulatory submission.
Keep reading
Related guides
Sources
References
- Crosby D, Bhatia S, Brindle KM, et al. Early detection of cancer. Science. 2022;375:eaay9040. doi.org/10.1126/science.aay9040
- Hanahan D. Hallmarks of cancer: new dimensions. Cancer Discovery. 2022;12:31–46. doi.org/10.1158/2159-8290.CD-21-1059
- Ludwig JA, Weinstein JN. Biomarkers in cancer staging, prognosis and treatment selection. Nature Reviews Cancer. 2005;5:845–856. doi.org/10.1038/nrc1739
- Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527. doi.org/10.1136/bmj.h5527
- National Cancer Institute. Early Detection Research Network (EDRN). edrn.cancer.gov/
- U.S. Food and Drug Administration. In Vitro Diagnostics. www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics
- World Health Organization. Guide to cancer early diagnosis. Geneva: WHO; 2017. www.who.int/publications/i/item/9789241511940
- International Council for Harmonisation. Efficacy guidelines, including E6 Good Clinical Practice. www.ich.org/page/efficacy-guidelines
Development status. OncoFirm™ assays and the handheld reader are in development. They have not been cleared or approved by the FDA and are not available for sale. Prototypes provided to collaborators are for research use only and are not for diagnostic procedures.
Propose a collaboration
Tell us about your specimens, study population or expertise and how you would like to work together. Submit a collaboration inquiry or contact us directly.