Bio-Rad Laboratories, a global provider of life science research and clinical diagnostic products, announced its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a “de novo” clearance from the U.S. Food and Drug Administration (FDA).
The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping in May and is the first in a series of infectious disease controls that Bio-Rad plans to introduce for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets.
Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Healthcare Associated Infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of Healthcare Associated Infections occur each year, leading to significantly high mortality rates.
According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one HAI. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.