The researchers will use a $1.2 million US Department of the Army grant to support studies on the detection of Borrelia proteins in patients' urine samples.

The updated regulations, which went into effect in January, reverse a previous CMS policy that had drawn broad opposition from the lab industry.

The National Institutes of Health funding and $1 million awarded in September from the National Science Foundation will support the firm's R&D.

The proposal outlines a pathway for some IVDs that have received regulatory approval in the US, EU, Canada, and Australia to be marketed in the UK.

Insurers are using prior authorizations to manage ballooning costs, but labs can be caught between patients and payors with ...

Last week, readers were most interested in a story about a warning not to use a Cue Health test due to an increased risk of false results.

Awardees include the National Institute of Standards and Technology, Detect-Ion, the US Food and Drug Administration, and the Wellcome Sanger Institute.

The firm is working with international and US partners to expand its validation data, with the goal of achieving IVD regulatory clearance across these markets.

The firm said that its NxTag Respiratory Pathogen Panel v2 adds detection of the SARS-CoV-2 virus for a total of 21 viral and bacterial targets.

The self-collection solution is approved for use with Roche's Cobas HPV test, which runs on the Cobas 4800, 5800, and 6800/8800 systems.

The patent fight is over technology that is intended to reduce the rate of false positive results in tests for bloodborne infections.

Balance Diagnostics USA was accused of paying kickbacks to physicians and their medical practices to secure patient referrals.