The company has developed a multiplex panel for bacterial and yeasts infections that it plans to submit for FDA clearance in 2027.
Industry representatives have voiced their support for the Biotech Act, hoping it will improve financing and institutional support of IVD makers.
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.
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 test supports rapid diagnosis, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases.
The companies will use Abbott's RT-PCR Simpli-Collect STI Test for detection and differentiation of the causes of sexually transmitted infections.
The test is a bead-based multiplexed immunoassay that also utilizes a machine-learning classifier to determine whether a ...
The US District Court for the District of Delaware announced the settlement this week, ending the dispute, which originated as a patent infringement suit by Invitae against Natera.
The company's SwiftX Virus extraction kit is used to prepare viral RNA and bacterial DNA for PCR-based testing for six arboviruses and one bacterial target.
The test uses autofluorescent single-walled carbon nanotubes to detect bacterial cell death in antimicrobial-containing microfluidic channels.
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.
The grant will support the development of RapiDetect CT/NG, the company's molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae.