Dive Brief:
- Avellino Lab USA, Cepheid and GeneMatrix have updated the emergency use authorizations for their COVID-19 tests.
- The companies are among the COVID-19 test manufacturers that have amended their fact sheets for patients and healthcare professionals to state that diagnostics cleared or approved by the Food and Drug Administration should be used instead of their emergency-authorized kits.
- GeneMatrix also updated the instructions for use for its kit, including by adding a statement that its performance has not been established with all circulating variants.
Dive Insight:
The FDA has stopped reviewing most COVID-19 tests under its EUA, requiring companies to instead seek De Novo classification or 510(k) clearance, and has drafted a plan for how the manufacturers of products with emergency authorization can transition to the routine regulatory framework.
Against that backdrop, companies with COVID-19 tests that came to market via the EUA pathway have been updating their materials to clarify when patients and healthcare professionals should use their kits. Companies began updating their fact sheets to cover approved alternatives last year. Avellino, Cepheid and GeneMatrix all updated their fact sheets this month.
Cepheid and GeneMatrix also updated other EUA documents. The latest copy of Cepheid’s EUA summary and GeneMatrix’s instructions for use feature statements about the lack of clinical performance data on circulating variants. The statements were missing from earlier versions of the Cepheid and GeneMatrix texts.
The companies removed references to “anterior” nasal swabs. GeneMatrix added a requirement for distributors to maintain records associated with the EUA “until otherwise notified” by the FDA.
