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FDA Approves BD High-Throughput Cor System, HPV Screening Assay

NEW YORK – Becton Dickinson announced Wednesday that it has received US Food and Drug Administration approval for its automated, sample-to-answer, high-throughput BD Cor system along with the BD Onclarity HPV Assay for extended genotyping of human papillomavirus.

The modular and scalable BD Cor is comprised of an automated sample preparation system called the BD Cor PX, and an instrument that automates the BD Onclarity HPV assay with extended genotyping, called the BD Cor GX. The BD Cor enables the processing of samples directly from liquid-based cytology vials, as well as the creation of molecular aliquot tubes and assay testing, automating labor-intensive and error-prone manual processes, BD said in a statement.

The Cor has onboard capacity for reagents and samples to provide up to eight hours of system processing, "eliminating multiple technologist interactions currently required per shift," BD also said.

The BD Cor was initially launched in Europe after obtaining the CE mark in 2019.

The BD Onclarity HPV obtained premarket approval from the FDA in 2018 to run on the BD Viper LT system and obtained supplemental PMA for extended genotyping to detect and distinguish 14 high-risk types of HPV using the assay in 2020. The firm also obtained CE mark for the Onclarity HPV assay using samples collected at home and processed on the BD Viper or BD Cor.

"The US launch of the BD Cor System is an important milestone on our molecular diagnostics roadmap, allowing us to offer sample processing automation and high-throughput molecular testing to our largest laboratory customers," said Dave Hickey, president of BD's life sciences division, in the company's statement.