PRESS RELEASE: Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests

Accelerate Diagnostics has filed a 510(k) premarket submission for a gram-negative menu expansion and breakpoint updates for its Accelerate PhenoTest BC kit used for antimicrobial susceptibility testing.

A previous version of the test and the Accelerate Pheno system received US Food and Drug Administration clearance in 2017 for rapid pathogen identification and phenotypic antibiotic susceptibility testing. In 2021, the firm began selling a new configuration of the kit in the US and secured CE marking for that configuration. The Tucson, Arizona-based firm said its recent 510(k) submission includes escalation and de-escalation agents for gram-negative organisms, additional antibiotics for treatment of Acinetobacter baumannii infection, and breakpoint updates for existing susceptibility measures. It also includes oral antibiotic options for de-escalation, which can aid patient discharge planning.

The Accelerate Pheno system and BC kit provide fully automated sample preparation and results in about seven hours direct from positive blood cultures.

Accelerate CEO Jack Phillips said in a statement that the updated PhenoTest panel "adds meaningful new antibiotic choices for clinicians to minimize time to optimal therapy for patients with bloodstream infections."

"These additions and improvements will increase the value of the Pheno system in hospitals across the country, enhancing the clinical value labs have been experiencing for the past several years," he said.

The firm said in May it plans to launch and commercialize a new system for MALDI mass spectrometry and update its Pheno platform, with clinical trials of the Pheno II instrument planned for 2023. It also entered into a commercial agreement this August with Becton Dickinson, which will sell the Accelerate Pheno system and Accelerate Arc module for antimicrobial susceptibility testing.

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PRESS RELEASE: Thermo Fisher Scientific Launches TrueMark Infectious Disease Research Panels

Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TrueMark Infectious Disease Research Panels designed to enable rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases.

To effectively study outbreaks and determine disease etiology where pathogens are similar, analytically sensitive panels are needed to support laboratory research. TrueMark Infectious Disease Research Panels are analytically sensitive, real-time polymerase chain reaction (PCR) syndromic panels for the analysis of a wide range of infectious disease pathogens.

Leveraging real-time PCR technology, the predefined and customizable panel options allow researchers to choose from more than 90 different bacterial and viral strain assays to generate results within four hours from taking the samples.

“With the TrueMark Infectious Disease Research Panels, laboratories can choose either the readymade panels or create their own custom panels to suit their needs,” said Dr. Manoj Gandhi, senior medical director of Genetic Testing Solutions at Thermo Fisher Scientific. “By providing the flexibility to choose panels for researching polymicrobial infections, laboratories can now expand their testing menus using existing instrumentation and offer the benefits of PCR testing for researching a broad range of markers that can cause infectious disease.”

The assays use pre-spotted and dried down TaqMan plates, which are designed to enable easy set-up and increased accuracy. Testing can be done from nasopharyngeal swabs or nasopharyngeal aspirate, vaginal, genital and lesion swabs or urine samples. These samples can also be prepared using workflows that currently exist in most labs that use the Applied Biosystems MagMAX Viral/Pathogen kits automated on a KingFisher Purification System instrument and mixed with the Applied Biosystems multiplex master mix onto a 96-well or 384-well plate.

The panels are optimized for use on QuantStudio qPCR systems with verified sample-to-answer workflow and provide easy to read results with the Applied Biosystems QuantStudio Design and Analysis Software v2.6.

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