Lateral Flow Assay Products & Services
Whether you are a global IVD company or a virtual start-up, developing and commercializing a lateral flow assay can present many challenges. Maybe you’re not able to achieve the clinically relevant range of your analyte, require extra manufacturing capacity to meet increased demand, or have a concept for an assay but need a trusted, experienced partner to make it a reality.
You’ve come to the right place.
We are a full-service lateral flow development company specializing in the manufacture of ultra-sensitive quantitative diagnostic assays. Our services span all phases of the development cycle from feasibility to manufacturing. We also offer industry-leading technologies for increasing assay sensitivity as well as starter kits to help you build and optimize your lateral flow assay.
Read on to see how our team can help!
End-to-End Lateral Flow Solutions – From Development Through Commercialization
At Fortis Life Sciences®, we can provide you with manufacturing assistance from the initial feasibility phase, right up to the final commercialization stage. This is how we do it.
Feasibility
We assist right from the very start; collaborating with you to define product requirements, to choosing reagents to engineering your proof-of-concept assay.
Optimization
Once you have your experiment designed, we can look at assay optimization and sample preparation stages.
Validation
Once the previous steps have been completed, we take the development through to the validation phase, to ensure the scale-up process is effective before commercialization of the manufactured product.
Why Partner with Us
Development of competitive and sandwich assay formats for protein hormones, steroid hormones, protein/protein complexes, peptide, serological response (IgM and IgG antibodies), drugs of abuse, fungal infection, bacteria, and viruses
Integration with multiple reader technologies for rapid, mobile, and quantitative point of care applications
Over 15 years of manufacturing and optimizing colloidal gold, gold reagents, and robust, reproducible conjugates
Proprietary gold nanoshells for the most sensitive quantitative and semi-quantitative visual detection, eliminating the need for costly filters or lenses
ISO 13485:2016 Certified* and contract manufacturer of prototype lots with up to 50,000 test strips and scaled manufacturing partners worldwide for larger quantities
On-site manufacturing of colloidal gold and gold nanoshells ensure a robust supply chain and enable large-scale production of strips and conjugates
High-Volume Lateral Flow Assay Manufacturing
With our high-throughput lateral flow assay manufacturing capabilities, Fortis Life Sciences is the efficient solution to help bring your company’s completed assays to market.
We’ve combined our nanomaterials expertise and comprehensive knowledge of medical devices to develop innovative manufacturing solutions that are tailored to meet your unique needs. Our automated reel-to-reel reagent deposition and lamination platforms generate high-sensitivity devices with proven reproducibility under our ISO 13485:2016 certified Quality Management System*.
Our resident biochemistry experts and on-site commercial-scale automated manufacturing provide unparalleled flexibility from start to finish, helping medical device companies bring new products to market with ease.
*For products within the scope of our ISO certification.
Equipment & Expertise:
- BioDot reel-to-reel dispensing & lamination
- Low humidity dry room for lamination & assembly
- 3000 sq ft available for manufacturing
- Equipped to produce up to 10 million lateral flow tests each month
What Our Customers Are Saying About Us
See what some of our past customers have had to say about working with us:
Wellness Ready
Working with nanoComposix has been equivalent to having an entire outsourced R&D department rather than working with a CRO. In addition to performing lateral flow assay development internally, nanoComposix has recommended and overseen ancillary research by third party CROs to meet the objective of our assay development program. The entire nanoComposix team has consistently exceeded my expectations with regards to both research and development and planning for commercialization of the resulting diagnostic technology. I would highly recommend that any business strongly consider nanoComposix for lateral flow assay development.
Patrick Lawless PhD - President and Founder - Wellness Ready
Noonan Holdings
After evaluating numerous labs, I spoke with nanoComposix and their enthusiasm and expertise pushed them to the top of the list. Their critical thinking and ingenuity led to a solution in a dramatically less time than was expected. Their team was very collaborative, providing regular updates and an open line of communication throughout. I would recommend them to anyone looking for a partner in assay development.
Ben Noonan - President & Founder - Noonan Holdings
Real-Time Analyzers
We recently contracted nanoComposix to develop a proof-of-concept lateral flow assay for therapeutic drug monitoring. nanoComposix worked on the project as if it was their own and not a contract R&D project, which showed their commitment and enthusiasm. We were thoroughly impressed with their meticulous approach in planning, designing and executing the project. Weekly updates were provided to ensure that the project was progressing within the prescribed time frame. The team at nanoComposix demonstrated a very high degree of scientific knowledge and technical expertise to successfully develop a working assay for us. We will definitely use nanoComposix lateral flow assay development services for all our future needs.
Chetan Shende - Research Chemist - Real Time Analyzers
Lateral Flow Services Case Studies
See real case studies on clients we have helped and the projects that needed completing:
Development of food safety assay using novel nanoparticles
Manufacture of validation lots of full rapid test kits under nanoComposix Quality Management System
Novel particles used for assay development, helped reach the limit of detection
Development of Lateral Flow Assay for Detection of a Physiological Disorder Biomarker
Development of Lateral Flow Assay for Therapeutic Drug Level Monitoring
Infectious Disease Detection by Nucleic Acid Lateral Flow
Disease-Causing Bacteria Detection by Lateral Flow Assay
Talk to Our Development Team
We’re here to help!
Our knowledgeable technical staff is available to help with your specific product, project, and technical questions. We look forward to learning more about what you’re doing and how we can help you succeed.
For custom materials, you can also check out our custom page to learn more about our custom capabilities and to submit a Custom Material Request Form to get started.
