Client:

AVIIR developed a lab-derived test that incorporated the levels of 7 unique biomarkers along with physiological metrics such as age, sex, and BMI to provide a risk score that correlated with a 5-year risk factor of a cardiac event caused by a lesion. This score would be used by the physician to counsel and advise patients to achieve lower cardiac event risks.

CHALLENGE

Situation:

Aviir’s lab derived test was designed such that a subset of the 7 biomarkers was measured on the MSD multiplex platform and the remaining biomarkers were assessed on the Luminex multiplex platform. Over time, the high costs, license fees and bridging issues associated with these two platforms lead AVIIR to look for a replacement technology that could measure all 7 biomarkers in a single assay.

Technical Need:

The replacement technology needed to meet or exceed the current individual performance specifications while combining the two subset arrays into a single plate. Finally, the solution needed to fit within the current regulatory environment of a lab-derived test and meet automation requirements.

SOLUTION

Utilizing the same content, Quansys acquired the necessary antibodies, calibrators and controls and assisted Aviir in building a replacement product. This development was guided by specifications drafted by AVIIR and followed by Quansys. This development took about 7 months and the teams communicated on a weekly basis of the project status.

RESULTS

Quansys provided the components for a new 7-plex product that had superior reproducibility along with improved sensitivity. This new product has a yearly savings of $420,000 over the predicate two-platform design.

Savings Moving to Q-Plex™

  • Kits: $353,000
  • Labor: 3000 hours per year
  • Sample: 150 μl/sample

Total: $420,000 per year