BioGx now offers 11 CE-marked infectious disease tests that run on Becton Dickinson's BD Max platform.
The list of regulated analytes needs to be reviewed and updated so that external quality controls are in place to protect patients, proficiency testing providers said.
IncellDx HPV OncoTect 3Dx system combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay, according to the firm.
Opko has until July 5 to comment on the proposed non-coverage local coverage determination, the most recent development in the test's twisted Medicare narrative.
BacterioScan has entered into a sales and distribution agreement for its 216Dx system with Fisher Healthcare, part of Thermo Fisher Scientific.
The kit, designed to rapidly detect 16 beta-lactam and carbapenem-resistant pathogen targets, was CE marked last month.
BacterioScan has signed a sales and distribution agreement for the system with Fisher Healthcare.
The claim, enabling streamlined screening of pooled samples, follows updated industry recommendations for Zika virus screening in the US blood supply.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
The company has developed a suite of tests designed to measure immunoglobulin E and immunoglobulin G levels for allergy and dietary wellness testing.
The US Attorney's Office, Western District of Pennsylvania alleged the doctors received improper payments for referrals from drug testing lab Universal Oral Fluid Laboratories.
The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.
The firm plans to soon seek US FDA clearance for its early sepsis indicator, which is part of a routine emergency department blood test.
Echo Lumena is Immucor's fifth-generation immunohematology instrument, and with the fully automated NEO platform, they offer a standardized workflow solution for laboratories.
The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.
PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients and is already being used in 35 countries in Europe, the Middle East, Asia, and Latin America.
The firm plans to eventually market a direct-from-blood platform that uses infrared spectrometry to identify drug-resistant pathogens within 20 minutes.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.
The firm said that its system combines many of the analytical strengths of a higher-volume instrument with the ease of a table-top analyzer.