Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access

Challenge

The client developed a multiplex respiratory antigen assay designed for rapid detection of multiple common respiratory viruses from a single nasal or nasopharyngeal swab. Intended for professional and near-patient use, this test offers the advantage of quickly differentiating key respiratory infections on a single device.

Their urgent goal was to secure CE-marking under the IVDR framework as fast as possible, aiming to launch ahead of the upcoming respiratory virus season. The shifting landscape, moving beyond COVID-19 to broader respiratory panels, meant timing was critical for maintaining a competitive edge and supporting public health efforts.

However, the client faced regulatory uncertainty. While COVID-19 was classified as Class D with specific common specifications, the other respiratory analytes fell under different rules, complicating the path to compliance.

Approach

QbD Group developed a focused IVDR clinical plan that balanced strict regulatory requirements with the need for speed. We designed a tailored performance evaluation to generate solid clinical data within a tight timeline.

Leveraging our strong network of study sites, we quickly identified locations capable of handling both professional and near-patient testing during the busy respiratory season. We managed ethical approvals, contracts, and logistics efficiently to launch the study without delay.

Throughout the process, we maintained close oversight, tracking progress and addressing challenges promptly. Clear communication and agile decisions helped us navigate the regulatory landscape smoothly.

Result

Our flexible and proactive approach enabled the client to gather the necessary clinical evidence for IVDR CE-marking right on schedule. Thanks to our wide-reaching clinical partnerships, sample collection was fast-tracked, taking full advantage of the respiratory season peak.

The collaborative and adaptive project management style ensured that every regulatory and operational milestone was met promptly. This timely delivery empowered the client to launch a distinct respiratory testing solution in Europe, strengthening their position as an innovation frontrunner during a critical period for public health.