CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 2018—FDA clears T2Bacteria panel for detecting sepsis-causing pathogens
T2 Biosystems received market clearance from the Food and Drug Administration for the T2Bacteria panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections.
The T2Bacteria panel provides sensitive detection of five sepsis-causing bacterial pathogens directly from a whole blood specimen in about five hours. This was more than 2.5 days faster than blood-culture–dependent tests as demonstrated in the more than 1,400-patient pivotal trial conducted at 11 hospitals in the United States, according to the company.
The T2Bacteria panel achieved an overall average sensitivity of 90 percent and an overall average specificity of 98 percent, while demonstrating no interference from the presence of antibiotics in the bloodstream, T2 Biosystems said in a statement.
“The results from the T2Bacteria pivotal clinical trial were impressive, demonstrating excellent performance and advantages over blood culture,” said principal investigator Minh-Hong Nguyen, MD, director of the antimicrobial management program and of transplant infectious diseases at the University of Pittsburgh Medical Center.
The T2Bacteria panel, like the previously FDA-cleared T2Candida panel, runs on the company’s FDA-cleared T2Dx instrument. T2Bacteria identifies the following: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
Veracyte provides early access to genomic classifier for IPF diagnosis
Veracyte has launched an early access program to begin making its Envisia Genomic Classifier available to patients being evaluated for interstitial lung diseases, including idiopathic pulmonary fibrosis.
Physicians from Thomas Jefferson University, Keck Medicine of USC, Providence Sacred Heart Medical Center in Washington state, and the University of California, Los Angeles, are among the first to participate in the program and offer patients the new genomic test.
The Envisia Genomic Classifier combines RNA sequencing and machine learning to improve the ability to differentiate IPF from other interstitial lung diseases through patient samples that are obtained by transbronchial biopsy. The 190-gene test detects the genomic pattern of usual interstitial pneumonia, a hallmark of IPF, with 88 percent specificity and 70 percent sensitivity.
“Our Early Access Program, while limited to a small number of institutions, will enable us to begin providing access to the test in advance of its anticipated, nationwide commercial expansion in 2019,” Veracyte chair and CEO Bonnie Anderson said in a statement.
A study published Jan. 17 in BMC Pulmonary Medicine (Cosgrove GP, et al. doi:10.1186/s12890-017-0560-x) found that more than half of patients with IPF or other interstitial lung diseases were misdiagnosed at least once and that, for four in 10 ILD patients, diagnosis took more than a year. Among those patients with IPF, more than one in five reported treatment during the diagnostic process with systemic corticosteroids, a potentially harmful therapy for IPF patients.