Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency.

Researchers at the University of California at San Francisco have developed a method to diagnose any known pathogen from any body fluid within a day – or, depending on the sequencing method, within a few hours. For an unknown pathogen, the method spits out its nearest known relative.

Day Zero Diagnostics Inc. has reported that data presented at IDWeek highlighted the promise of the company’s new class of diagnostics as it works toward its goal of detecting superbug infections quickly. The company ultimately is hoping to get regulatory signoffs in both the U.S. and Europe for its technology.

An international research team has identified a bacterial/viral combination more likely to be present in children with postinfectious hydrocephalus.

A team of scientists at Duke Health has identified biomarkers that accurately detect viral infections before a person becomes symptomatic. The findings were published in The Lancet Infectious Diseases.

Researchers at the University of Virginia have used a retrospective database analysis to show that the use of nucleoside reverse transcriptase inhibitors for the treatment of HIV or hepatitis B reduced the risk of developing type 2 diabetes by 33%.

The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human deficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.

The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of multidrug resistant tuberculosis (TB). The new test enables clinicians to return results in 90 minutes and see immediately whether the pathogen would respond to standard first- or second-line therapies.

The checkpoint molecule CD47 has high hopes riding on it in oncology as being the innate immune equivalent of PD-1. Multiple companies are developing blockers against CD47 and/or its ligand, SIRPa, for the treatment of various tumors.

Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.