BD locks down FDA approval for automated molecular diagnostics platform, with initial test for HPV

As the science and technology behind genomic sequencing progresses, high-throughput molecular testing has increasingly become a crucial tool in identifying diseases in their earliest stages. Despite these technological advancements, however, even the tiniest of human errors can completely throw off the results.

The solution? Leave the humans out of it.

BD’s latest offering in the realm of molecular diagnostics, the BD Cor platform, aims to do just that, by completely automating the bulk of the testing process. It comprises two instruments: the BD Cor PX and the BD Cor GX.

The PX instrument is in charge of preparing specimens for testing. It accepts sealed vials and collection devices, extracts the required amount of the sample and re-seals the container before pre-warming and cooling the sample as needed, then delivering it to the GX instrument. Once delivered, the BD Cor GX automatically performs the extraction, amplification and detection required for extended genotype testing.

The entire automated process is powered by a combination of robotics and sample management software algorithms that all but eliminate the need for human involvement between sample processing and the delivery of the test results. In addition, the BD Cor system can continuously process samples for up to eight hours at a time, further reducing the need for direct human interactions.

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The platform is currently used only with BD’s Onclarity assay for human papillomavirus, or HPV. According to the company, the test is the only extended genotyping test for HPV currently approved by the FDA; the assay can detect more than a dozen individual high-risk HPV types at once, making it a valuable tool in cervical cancer screening.

The BD Cor system received CE mark clearance for distribution in Europe in 2019. With its newly bestowed FDA approval, the diagnostics platform and HPV test can now be used for molecular testing in labs across the U.S.

“Testing labs may report results for hundreds of thousands of women each year, and automation can help labs enhance and standardize the quality of the results,” said Brooke Story, BD’s president of integrated diagnostic solutions. “We watched how specimens make their way through labs and saw how much handling was needed both before and after the test, and we knew our expertise in robotics could help.”

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The Onclarity HPV assay has already been in use in the U.S., where it was cleared by the FDA last year for analysis by BD’s Viper molecular diagnostics platform.

Additionally, earlier this year, the test received another CE mark allowing the assay to be processed using self-collected samples. At the time, BD suggested that allowing for at-home sample collection would help mitigate the increasing numbers of women around the world who forgo regular screening for cervical cancer.