Skip to main content
Premium Trial:

Request an Annual Quote

Prodesse Gets FDA OK for H1N1 Claims for Assay

This article contains a clarification in the first graf regarding the claims for the ProFlu+ assay.

NEW YORK (GenomeWeb News) – Prodesse today said that the US Food and Drug Administration has cleared additional claims for the firm's ProFlu+ assay, which says that it correctly identifies as Influenza A positive specimens containing novel 2009 H1N1 influenza virus.

The Milwaukee, Wis.-based firm said in a statement that reactivity testing completed by the firm confirmed that the ProFlu+ test correctly identifies the Influenza A positive specimens containing novel 2009 H1N1 influenza virus. It noted that the testing was conducted on cultures of clinical isolates confirmed as 2009 H1N1 Influenza Virus using the CDC's real-time RT-PCR assay.

Prodesse also noted that its can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

"Prodesse's recently completed reactivity testing confirms that our ProFlu+ test can be an important tool for health care professionals in the diagnoses of their patients, particularly during the Influenza A outbreak," Tom Shannon, president and CEO of Prodesse, said in a statement.

The ProFlu+ assay was initially cleared by FDA in January 2008 for the detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus.

Last month, FDA issued an Emergency Use Authorization for Focus Diagnostics' molecular assay for detecting the 2009 H1N1 flu virus.

The Scan

Panel Recommends Pfizer-BioNTech Vaccine for Kids

CNN reports that the US Food and Drug Administration advisory panel has voted in favor of authorizing the Pfizer-BioNTech SARS-CoV-2 vaccine for children between 5 and 11 years old.

Sharing How to Make It

Merck had granted a royalty-free license for its COVID-19 treatment to the Medicines Patent Pool, according to the New York Times.

Bring it Back In

Bloomberg reports that a genetic analysis has tied a cluster of melioidosis cases in the US to a now-recalled aromatherapy spray.

Nucleic Acids Research Papers on SomaMutDB, VThunter, SCovid Databases

In Nucleic Acids Research this week: database of somatic mutations in normal tissue, viral receptor-related expression signatures, and more.