In April 2021, Qorvo were granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The EUA approval is a major milestone in the collaboration between Qorvo and SCHOTT MINIFAB over the past two years.
- Fundamental elements of the process for successful assay translation through an early design perspective.
- A universal workflow for complex microarray development and performance optimization
- The performance advantages of nanoparticle bioconjugation in point-of-care assay development
Developing a fully integrated consumable cartridge for an automated diagnostic platform is a significant challenge. More challenging still is developing such a cartridge in response to a deadly global virus pandemic amid market uncertainty and extraordinary time constraints.
TearLab® Corporation, together with SCHOTT MINIFAB are celebrating an important milestone with the delivery of the 20 millionth microfluidic eye test card from the production line in Melbourne, Australia. The milestone comes as a result of a 13-year contract manufacturing partnership between the two companies, beginning in 2007 with an ambitious microfluidic product development program.
When it comes to managing and mitigating product development risk, there are six guiding principles that are proven to work.
Market leader in microfluidic device manufacture has re-branded from MINIFAB to SCHOTT MINIFAB. The change of name and visual re-brand comes after SCHOTT AG acquired the company in July 2019 and forms one part of an ongoing integration process.
Taking a long-term view at the outset of the cartridge development program is critical for reducing the cost of goods (COGS) when the time inevitably comes to ramp up manufacturing volume.
Are you developing a diagnostic microfluidic product? Validating assay maturity is critical for commercial success.
Edward Wilkinson, Vice President of SCHOTT MINIFAB USA and Head of Strategy, explains why a fully integrated bioscience and engineering approach is the key to risk mitigation.