February 16, 2021

Diagnostics development services

By Cytiva

Converting an idea or lab-based test to a lateral flow assay is a long process with technical and financial challenges.

Do you have an idea for a rapid diagnostic test with great commercial potential, and need support in getting the product to market?

Or perhaps you already have a lab-based test you want to adapt to a lateral flow assay for point of care testing, but lack the infrastructure and expertise to do so?

We can help.

The path from an idea or lab-based test to an approved rapid diagnostic test is challenging. There are technical, financial, and regulatory hurdles in developing a marketable lateral flow assay. In this blog, learn how we support early stage developers on their path to market by:

  • Providing access to state-of-the-art infrastructure.
  • Offering the benefit of over 40 years’ experience in developing diagnostics.
  • Accelerating progress between key development stages.

From scientific concept to successful prototype, we’ve got you covered with Cytiva Diagnostic Services.

Ask us about supporting your diagnostics development

Put our team to work for you

Our immunoassay development services, part of Cytiva Diagnostic Services, builds on our Whatman heritage of quality and innovation, providing early stage developers access to our expertise, infrastructure and proven development methodologies. Dr Klaus Hochleitner, an industry-recognized expert in point of care diagnostics development, leads our Diagnostic Services team in Dassel, Germany of highly-trained and experienced specialists.

This team of assay development experts has enabled many early stage development successes. Our team works with complete transparency in state-of-the-art laboratories to solve challenges and optimize your prototype development, shortening your path to market.

Accelerating your product development process

As the development of a point of care testing devices is a time- and cost-intensive process, getting from idea to proof-of-principle as quickly as possible is vital for releasing the next stage of funding. The Cytiva Diagnostic Services team makes that process as speedy as possible without compromise.

The team has considerable experience and capabilities in the selection and customization of test components, as well as an understanding of the underlying science of rapid diagnostic test design. As part of the service, the team will:

  • Anticipate and implement considerations for design robustness.
  • Work with different design formulations in parallel to minimize time and cost.
  • Optimize test conditions so they are repeatable at both small- and large-scale quantities.
  • Utilize only high-quality components supported by robust supply chains.

Taking this approach, you benefit from our expertise — knowing what avenues to pursue and mistakes to avoid — and have access to our modern laboratories and experienced personnel.

We perform the entire assay development process with transparency. We involve you throughout, sharing the lessons we have learned, and document everything to make sure you have complete confidence in the scientific design and robustness. You will have the flexibility to use all or just some of our services, according to your needs.

  • Proof of principle/concept production
  • Protocol development
  • Design/protocol transfer
  • Methods qualification
  • Reference standard characterization
  • Stability studies
  • Lot release testing
  • Raw material inspection and testing
  • General assay troubleshooting
  • Design seminars and small group tutorials
  • Gap manufacturing

Training and education in diagnostics development

Maximizing our collaboration includes positioning you to take your lateral flow assay development forward and be in a fully informed position for your next project. So, as part of Cytiva Diagnostic Services, we also provide hands-on training and education, both on-site at our Dassel, Germany or off-site at locations convenient to you.

The training and education include:

  • On-site access and participation during all development activities.
  • Test development lab for proof of concept.
  • Support staff at your site for start-up activities.
  • Access to process, equipment, and development training.
  • Site safety training.
  • Classroom, on-site, and online education.

Meeting your needs with our solutions

“Getting a new enterprise off the ground while keeping a focus on the science is challenging. Expertise lies in knowing what needs to be done as well as what doesn’t. The latter is equally important for minimizing time to market for your lateral flow assay.

At Cytiva, we’ve learned from many years of experience how to minimize trial and error and get assay development right the first time. Our goal is to enable your success as you pass through the initial prototype stage. We will help you present a validated, de-risked prototype as the proof of principle needed for investor confidence and continued funding.”

Dr Klaus Hochleitner, Lead, Cytiva Diagnostic Services

Cytiva diagnostic services

In addition to immunoassay development services, we offer a range of solutions to simplify your molecular and immunodiagnostics workflows.

These solutions include lyophilization, conjugation, contract manufacturing, custom biology and custom plates. Whether creating a custom magnetic bead, a specialized enzyme, or a convenient kit, we develop your minimal viable product to assess functionality, stability and appearance, followed by proof-of-principle studies to optimize the product and ensure that we can scale the product up and meet quality standards. Tailored to your precise specifications, our custom diagnostics products deliver reliable performance with lot-to-lot consistency assured. Find out more.