System approved for highly automated cervical cancer screening

A high-throughput molecular diagnostic system that is fully automated has won approval from the U.S. Food and Drug Administration and now is available in the U.S. market for cervical cancer screenings.

The BD COR™ PX/GX System from Becton, Dickinson and Co. (BD), Franklin Lakes, New Jersey, won regulatory clearance on Tuesday, clearing the hurdle to be sold stateside. The system has been available in Europe since 2019, officials said, where it has multiple market placements.

“We’re very excited to have the system available in the U.S.,” said Chris Beddard, business line leader for Core Molecular Diagnostics and Women’s Health & Cancer, BD Integrated Diagnostic Solutions.

The system is engineered with robotics and sample management software algorithms, according to BD. With this launch, the BD Onclarity™ HPV Assay with extended genotyping for the BD COR System now is available to high-throughput labs that process the majority of cervical cancer screening specimens, the company said.

Beddard, in an interview with Contemporary OB/GYNÒ, said that they evaluated the laboratory needs of today where there is more consolidation, higher volume, and the fact that labor is hard to come by. The system integrates the entire molecular laboratory workflow, from sample processing to the diagnostic test result.

“We were making sure we could completely automate the process,” she said. “Once again, it is that combination of full automation and integrated processing, with Onclarity™ that makes this an important offer in U.S market.”

Officials watched how specimens made their way through labs and saw how much processing was needed both before and after the test, said Brooke Story, president of Integrated Diagnostic Solutions for BD, in a press release.

Beddard emphasized that BD is eliminating multiple interactions and empowering large labs to gain the efficiencies. The PX is the instrument that manages the samples. It sorts and processes the liquid-based cytology vials and sends them to the GX module, where the testing takes place. The system can manage up to 30 of the sample racks. There is full traceability via barcoding.

Beddard also said that the system facilitates extended genotyping. According to the press release, the BD Onclarity™ HPV Assay offers extended genotyping capabilities by detecting 14 high-risk (HR) HPV types in a single analysis. Officials said that the BD Onclarity™ HPV Assay is the only FDA-approved HPV test that can identify and report genotypes beyond 16, 18 and 45, to include individual results for 31, 51, 52 and grouped results for 33/58, 35/39/68, and 56/59/66. The BD Onclarity™ HPV Assay can be used as a component of routine cervical cancer screening programs, with indications for HPV primary screening, triage for ASC-US cytology and co-testing with cytology.