Madeleine covers PCR, nucleic acid amplification, and sample prep technologies for GenomeWeb and 360Dx.
The Park City, Utah-based firm combines RT-LAMP with lyophilization and a scalable manufacturing system for its laminate card technology that keeps costs low.
The firm expects to establish a US-based development and manufacturing footprint for its multiplex PCR assay kits.
The firm submitted a low-cost RT-LAMP device and COVID test to the FDA for Emergency Use Authorization this week.
Molecular diagnostics revenue dropped 47 percent due to lower volumes and selling prices for COVID-19 PCR products.
The firm provided updates on its business while it undergoes an internal strategic review process aimed at enhancing shareholder value.
A team in South Korea has developed a method that can increase sensitivity when paired with surface-enhanced Raman spectroscopy.
Newly merged with a firm founded by BioFire Diagnostics alums, Co-Diagnostics plans to develop small panels for the system with up to six targets.
The FDA thus far has not been interested in PCR tests to identify specific SARS-CoV-2 variants, but that may be changing with the emergence of Omicron.
With new financing from Koch Disruptive Technologies and guidance from industry experts, the firm expects to launch its system next year.
The Boston-based firm recently received an influx of funding and brought on a chief commercial officer to support these efforts.