Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Nanosphere's Respiratory Pathogen Test

NEW YORK (GenomeWeb) – Nanosphere today announced that it has received 510(k) clearance from the US Food and Drug Administration for its Verigene Respiratory Pathogens Flex test (RP Flex).

The RP Flex PCR-based test features new software that allows the Verigene System to identify 16 viral and bacterial targets, either as a full multiplexed panel or in user-defined subsets.

"Verigene RP Flex addresses a previously unmet healthcare need for our laboratory customers by bridging the gap between one-size-fits-all syndromic panels and targeted single-analyte tests," Nanosphere CEO Michael McGarrity said in a statement.

The test is the fifth FDA-cleared test in Nanosphere's menu of infectious disease diagnostics for the Verigene system. It follows the Verigene Gram-Positive and Gram-Negative Blood Culture Tests, the Enteric Pathogens test, and the Clostridium difficile test.

In October 2014, Nanosphere received FDA clearance to add norovirus and rotavirus to its Enteric Pathogens test.

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.