Skip to main content
Premium Trial:

Request an Annual Quote

Beckman Coulter Plans FDA Submissions in May or June for Troponin Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Beckman Coulter today said that it anticipates filing for US clearance on its troponin test during May or June.

In a document filed with the US Securities and Exchange Commission, the Orange County, Calif.-based firm said that it plans to file two separate 510(k) applications with the FDA for the troponin test, one to be run on its Access instruments, the other on its Dxl instruments. Its time estimate is based on the current status of its clinical trial for the test, including site and patient enrolment, and preliminary myocardial infarction incidence rates observed.

Beckman Coulter had previously stated that it anticipated submitting to the FDA for the troponin test in the first half of this year.

The test had run into quality control problems a year ago when the company informed customers of a positive bias in results for its troponin test kits running on its UniCel Dxl immunoassay system.

Beckman Coulter is reportedly in the process of shopping for a buyer in a deal that could fetch $5 billion.

The Scan

Gone, But Now Reconstructed SARS-CoV-2 Genomes

In a preprint, a researcher describes his recovery of viral sequences that had been removed from a common database.

Rare Heart Inflammation Warning

The Food and Drug Administration is adding a warning about links between a rare inflammatory heart condition and two SARS-CoV-2 vaccines, Reuters reports.

Sandwich Sampling

The New York Times sent tuna sandwiches for PCR analysis.

Nature Papers Describe Gut Viruses, New Format for Storing Quantitative Genomic Data, More

In Nature this week: catalog of DNA viruses of the human gut microbiome, new dense depth data dump format to store quantitative genomic data, and more.