The company has developed a multiplex panel for bacterial and yeasts infections that it plans to submit for FDA clearance in 2027.

Last week, readers were most interested in a story about the FDA rescinding a rule issued more than a year ago covering the oversight of laboratory-developed tests.

Industry representatives have voiced their support for the Biotech Act, hoping it will improve financing and institutional support of IVD makers.

The test is a bead-based multiplexed immunoassay that also utilizes a machine-learning classifier to determine whether a ...

The company recently published a study showing that elemental patterns in single strands of hair are different in patients ...

Stakeholders noted that challenges like supply chain breakdowns and staffing shortages are too global in scope for any one ...

The fully automated PCR-based testing system will be used in microbiology and virology labs to aid the detection of viral and bacterial causes of infectious diseases.

A new test to help select colorectal cancer therapy is the first in a menu of rapid cartridge-based tests the firm is planning to support cancer testing.

The agency said that during emergencies it will balance the risks of delaying access to tests compared with the risks of harm from inaccurate test results.

The company plans to launch in 2026 a program that will provide labs with scanners free of charge in exchange for volume-based payments for biomarker tests.

The grant will support the development of RapiDetect CT/NG, the company's molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae.

The test uses autofluorescent single-walled carbon nanotubes to detect bacterial cell death in antimicrobial-containing microfluidic channels.