BioAssay Works assay-development services allow companies to quickly enter a rapid test market with a minimum investment of resources and time. Our services range from a simple assay-feasibility project to a full-scale development project, including custom manufacturing.

Assay Types

We specialize in developing rapid assays utilizing our deep expertise in gold nanoparticles, including:

  • Lateral-flow assays (single/multiple analytes)
  • Dipsticks
  • Flow-through systems
  • Qualitative assays (yes/no)
  • Semi-quantitative assays (reader devices)

We have experience working with a large variety of sample types such as saliva, whole blood, serum, tears, urine, feces, biopsy fluids, cell culture supernatant, bacterial broth, etc. and have developed assays for both antibody and antigen detection.

Our Experience Counts

Since 2005, we have successfully developed and manufactured dozens of custom rapid assays for a variety of clients for:

  • Human medicine (biomarkers and pathogens)
  • Veterinary medicine (infections, fertility)Assay Development
  • Food industry (allergens, bacteria, toxins)
  • Pharmaceutical (vaccine production monitoring)
  • Industrial monitoring devices
  • Biodefense (biowarfare agents)
  • Environmental (contaminants)
  • Nucleic acid tests

Many of these assays deliver lab-based assay sensitivity in a rapid assay suitable for field or non-laboratory use. We are proud of our track record of developing successful rapid assays for our clients. Let us put this experience to work for you.

Our Technology Makes a Difference

We have four core technologies that we use to help our customers bring lab-based assay sensitivity to point-of-care, rapid assays:

  1. Ultra-sensitive, concentrated gold-sols that do not use the traditional boiling, reduction process to manufacture the nanoparticles and result in a 15 – 100 O.D. concentrated gold-sol, the foundation for ultra-sensitive assays.
  2. The unique properties of our concentrated gold nanoparticles enable us to covalently conjugate antibodies, antigens and other ligands. This ensures an optimized and very stable gold conjugate.
  3. A proprietary gold-ribbon drying process that enhances the release of the gold conjugate from the conjugate pad contributes to an increase in assay sensitivity.
  4. Our patented C-FLAT® lateral-flow assay platforms (US Patents #7,910,381 and #7,344,893) enable increased assay sensitivity.

 

Our Process

Clients are in control of each assay-development project and can choose to continue or end the project at any time. Each project is thoroughly documented to help ensure assays can be reproducibly manufactured at the conclusion of the project.

Every project is unique, but most projects follow our three-stage process. Absent an early determination of infeasibility, most assay-development projects proceed to completion.

Stage 1 - FeasibilityThis stage quickly provides insight into whether a rapid test has a reasonable chance for success.
DurationNormally, 6-10 weeks
DeliverablesFeasibility Report
Client DecisionProceed to Development, perform additional feasibility work, or end project.

Stage 2 - DevelopmentA working prototype assay is developed. Initial optimization of various assay components (membrane, gold conjugate pads, wicks, concentrations of assay reagents) is performed.
DurationNormally, 6-12 weeks
DeliverablesDevelopment report detailing assay design, limits of detection, assay duration, and results from testing samples. 50-100 assay prototypes for client use
Client DecisionProceed to Optimization stage, perform additional development work, or end project.

Stage 3 - OptimizationThe prototypes produced in the Development stage are further optimized and will reflect the insight gained from your evaluation. The process for assay manufacturing is fully documented in preparation for production by BioAssay Works or transfer of non-proprietary components to you for manufacturing.
DurationNormally, 6-12 weeks
DeliverablesOptimization report detailing any optimization done to the assay, SOPs for the manufacture and quality control of rapid assays.
Client DecisionWho will manufacture test (BioAssay Works, client, third party)?

Getting Started

Contact us at 1-301-874-8888 or at sales@bioassayworks.com to discuss your project. We would be happy to provide you with a customized quote.

Working with Bioassay Works (BAW) delivered us top notch efficiency, improved assay performance and reduced development cost. Undoubtedly, BAW was a stellar product development partner that brought special touch of quality, responsiveness and dedication to our project, which allowed us to rapidly advance our product to market.  

– Manufacturer of novel diagnostic tests that address unmet global health needs

BioAssay Works was able to provide reagents and prototype test strips for an assay I was consulting on in a very short turnaround time.  They were very open to discussing the different options required to further optimize the kit.  BAW was able to work with our required constraints. Overall, it has been a pleasure working with the BAW team. They added value by saving us substantial time and money by providing these development services.  I look forward to continue working with them on our current and future projects.

David Yost, Ph.D. – Senior Consultant, Life Science/IVD