Valve-Free Positioning and Preserving of Reagents for Sample-to-Answer Diagnostics

Customer Problem

  • GenMark Diagnostics partnered with Biomatrica to position and preserve reagents on a microfluidic device.
  • Current reagent storage technologies (e.g. lyophilization) complicate microfluidic assays, requiring engineering and manufacturing solutions that introduce risks and costs.
  • The goal was to control costs, rapidly expand the test menu, and receive CLIA approval.

Biomatrica Solution

  • Biomatrica developed solutions that preserved performance of individual qRT-PCR reagents and complete master mixes.
  • Initial solutions were further optimized for use in the partner’s platform.
  • Solutions delivered to the customer preserved assay reagents in a dry state while adhering them to a microfluidic cartridge.

Preserved reagents match fresh performance

Dried RT-PCR Reactions

Biomatrica example data: Preservation of a quadplex RT-PCR assay reaction for Influenza RNA. Reactions were either prepared at the time of assay (Fresh), stored without preserving formulations (Nonprotected), or stored in the presence of different Biomatrica formulations (Preserved). Assays were stored for 2 months at 45°C.


Customer Impact

  • Production was scaled up at GenMark's facilities while achieving product cost targets.
  • The product had sufficient ease-of-use to apply for moderate complexity CLIA approval.
  • GenMark expects to launch multiple tests for the near-patient market, resulting in 3X-5X organic growth.

Customer Testimonial

It's clear from the success we've had from our first assays that Biomatrica is a great collaborator.
- Jon Faiz Kayyem, PhD, Founder & Sr. Vice President, Research & Development, GenMark Diagnostics, Inc.

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