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More articles about Regulatory News & FDA Approvals

Representatives of NBs said they are adding capacity to allow oversight of the anticipated wave of submissions before the new IVD Regulation comes into force in three years.

Filter tips for use with QiaSymphony SP/AS instruments may leak, which could lead to delayed or inaccurate results and cause serious injury or death.

Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.

Ortho's assay, which aids in quickly and accurately diagnosing heart attacks, runs on its new Vitros XT 7600 Integrated System, among other Ortho systems.

The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.

The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.

The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.

NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.

The company said it got CE marking for use of its Vitros NT-proBNP II immunodiagnostic assay to diagnose and assess heart failure and enable risk stratification.

Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.

The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.

The ARUP COO recently published a commentary providing the clinical lab perspective on recent congressional proposals around LDT regulation.

Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.

The test could potentially enable labs to bring resistance testing in house, rather than send testing out to Canada's National Microbiology Laboratory.

The iC-GN Assay detects target DNA and identifies gram-negative organisms associated with gram-negative bacteremia, and three antibiotic-resistance markers. 

The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.

The firm said that the system's automation and flexibility will help centers be more productive within a testing specialty that can require extensive hands-on time.

The lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer.

Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.

Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.

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