The ID Pipeline: FDA Activity From the Week of January 19, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 19, 2020.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of January 19, 2020.

NIAID Launches Clinical Trial to Test Long-Acting Combination HIV Treatment

The National Institute of Allergy and Infectious Diseases (NIAID) is launching a Phase 2 clinical trial of long-acting cabotegravir in combination with the HIV antibody VRC07-523LS.

The investigators of the trial are studying whether the combination is tolerable and prevents HIV from rebounding to detectable levels among those who previously kept the virus suppressed with daily antiretroviral treatment.

Read the full press release.

LexaGene Holdings Pathogen and Antibiotic Resistance Tests Achieve 100% Concordance

LexaGene Holdings has announced an expansion of its validated tests for antibiotic resistance. The company has completed testing of different superbug isolates provided by the US Centers for Disease Control and Prevention.

LexaGene’s automated, molecular based diagnostics were tested against antibiotic-resistant pathogens and the tests detected 100% of targeted genetic sequences. The study was broken into 2 parts, pathogen identification and antibiotic resistance detection.

Read the full press release.