The European CE mark has been granted to Beckman Coulter for its Early Sepsis Indicator, a hematology-based solution designed to identify patients who either have or are at risk of developing sepsis. This is the first early sepsis warning test to be offered as part of a complete blood count with differential. Because it is part of a routine blood test, it will not create any additional workflow burden for the laboratory or emergency department and should decrease time to result. The test runs on Beckman’s recently launched DxH 900 hematology analyzer, which uses enhanced Coulter technology to characterize cells in their near-native states and detect morphological changes in monocytes. Monocytes play a role in the dysregulated immune response to sepsis and, according to Beckman Coulter, identifying morphological changes in these cells provides insight into possible sepsis earlier than other indicators.
Now that the company has received the CE mark for the Early Sepsis Indicator, it plans to submit the test to the Food and Drug Administration in the near future for 510(k) clearance.
FDA Seeks Proposals for Medical Devices That Could Help Combat Opioid Epidemic
As part of the Food and Drug Administration’s (FDA) ongoing efforts to address opioid abuse in the U.S., the agency has launched an innovation challenge to spur the development of medical devices—including diagnostic tests and digital health technologies—that could provide novel solutions for detecting, treating, and preventing addiction; addressing diversion; and treating pain. The agency is encouraging developers to submit proposals to the challenge, which is open to products in any stage of development from concept to testing. In the diagnostic field, examples of potential products FDA is looking for include tests to identify patients at increased risk for addiction or technologies that prevent diversion of prescription opioids. Companies selected by FDA through the challenge will then have the opportunity to work closely with the agency to accelerate the development and review of their innovative products.
“We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis,” said FDA Commissioner Scott Gottlieb, MD.
FDA will accept proposals submitted to CDRH-Innovation-Opioids@fda.hhs.gov through September 30 and intends to announce the selected applicants in November of this year.
Roche Gets Expanded FDA Approval for Zika Blood Donation Screening Test
The Food and Drug Administration (FDA) has approved an additional claim for Roche’s cobas Zika test for use on the cobas 6800/8800 systems. The test is a qualitative in vitro nucleic acid screening assay for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors and was originally released under FDA’s Investigational New Drug Application protocol before receiving commercial approval in October 2017. The newly approved claim allows this test to be used for screening multiple individual blood or plasma donations that have been pooled together. This follows the updated industry recommendations for screening the U.S. blood supply made at the December 1, 2017, meeting of the Blood Products Advisory Committee (BPAC), an appointed group of key medical and scientific advisors to FDA. In addition to supporting the most recent BPAC recommendations, the extended claims for cobas Zika aim to facilitate a simplified testing workflow for blood screening laboratories.
Cepheid Strep Test Receives FDA Clearance, CLIA Waiver
Cepheid has earned Food and Drug Administration 510(k) clearance as well as a waiver under CLIA for the Xpert Xpress Strep A test. The test is intended to diagnose pharyngitis caused by Streptococcus pyogenes (group A strep) and to reduce the use of antibiotics in treating pharyngitis due to organisms other than group A strep. As a CLIA-waived test, the Xpert Xpress Strep A can be performed in near-patient settings by untrained users. It uses on-board reagents and automated real-time polymerase chain reaction to detect the SpeB gene of Streptococcus pyogenes, generating positive results in as little as 18 minutes and negative results in about 24 minutes. The test exhibits a sensitivity of 100% and a specificity of 94.1%. There is also no requirement for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever.
Australia OKs Genetic Signaturesh2’ Test for Antibiotic Resistant Pathogens
Genetic Signatures has received registration from Australia’s Therapeutic Goods Administration for its EasyScreen Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms (ESBL & CPO) detection kit. Earlier this year, the test also received the European CE mark. The ESBL & CPO kit detects 16 beta-lactam and carbapenem-resistant pathogen targets in less than 3 hours. It uses real-time polymerase chain reaction coupled with Genetic Signatures’ 3base Technology, a multiplex system that identifies methylation patterns in DNA and is also compatible with RNA specimens. 3base Technology works by using the bisulphite method, which converts all cytosines into thymines in unmethylated DNA, thereby converting a four-base pair sequence into a three-base pair sequence of only adenines, thymines, and guanines. By eliminating cytosines from an organism’s genome, 3base simplifies DNA sequences and makes it possible to use one assay to identify all variants within a class of microbial species.
BioGX Earns CE Mark for Meningitis and Antibiotic Resistance Tests
The CE mark has been granted to BioGx for six infectious diseases tests designed to run on Becton Dickinson’s BD Max platform: The Viral Meningitis HSV/VZV test aids in the diagnosis of viral meningitis by detecting DNA from herpes simplex virus-1, herpes simplex virus-2, and varicella-zoster virus, while the Bacterial Meningitis NSH and Bacterial Meningitis ELGBS tests aid in the diagnosis of bacterial meningitis by detecting DNA from Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, and from Escherichia coli, Listeria spp., and group B Streptococcus, respectively. The Carbapenem Resistance KNO test aids in the detection of carbapenem resistant Enterobacteriaceae and other organisms resistant to carbapenem harboring DNA from resistance genes KPC, NDM-1, and OXA-48. The Carbapenem/Colistin Resistance VGM test aids in the detection of carbapenem and/or colistin resistant Enterobacteriaceae and other organisms resistant to carbapenem and/or colistin harboring DNA from resistance genes VIM, GES, and mcr-1. The last test, Vancomycin Resistance, aids in the detection of vancomycin resistant Enterococcus and other organisms resistant to vancomycin harboring DNA from resistance genes vanA, vanB, vanC1, and vanC2/3.