BD launches FDA-approved, highly automated cervical cancer screening system

BD announced that it has launched a new, fully automated high-throughput diagnostic system using robotics and sample management software algorithms to set a new standard in automation for infectious disease molecular testing in core laboratories and other centralized laboratories in the United States.

Cervical cancer is most commonly caused by human papillomavirus, or HPV, a sexually transmitted disease that affects the uterus.

Each year, over 13,000 individuals are diagnosed with cervical cancer in U.S. But, an influx of screening and awareness on the importance of vaccination has lowered these numbers.

Franklin Lakes-based BD, or Becton, Dickinson and Co., is taking that screening one step further by recently launching a fully automated, high-throughput diagnostic system to screen for cervical cancer.

The BD COR PX/GX System won approval from the U.S. Food and Drug Administration in late August, clearing the way for it to be used in the U.S. The system has been available in Europe since 2019, and is ready for use in centralized labs that can handle high-volume processing and increases in efficiency.

Chris Beddard. (BD)

“With our BD COR PX/GX System, we are able to talk to high volume, high-throughput diagnostic laboratories that have consolidated their testing and molecular solution and provide the clinicians with as much information as possible, which helps to better determine the risk and better manage the patient going forward,” said Chris Beddard, business line leader for Core Molecular Diagnostics and Women’s Health & Cancer, BD Integrated Diagnostic Solutions. “We’re very excited to have the system available in the U.S.”

Beddard said the BD Onclarity HPV Assay offers extended genotyping capabilities by detecting 14 high-risk HPV types in a single analysis. Now, with FDA approval, the BD COR GX instrument can automate the BD Onclarity HPV Assay with extended genotyping.

According to Beddard, the BD COR System integrates and automates the complete molecular laboratory workflow from sample processing to diagnostic test result. The system is modular, scalable and designed to address multiple needs within laboratories for expanding molecular testing and increasing test volumes.

“It has onboard capacity for reagents and samples that provide hours of unimpeded system processing, which eliminates multiple technologist interactions required per shift,” she said

“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, president of integrated diagnostic solutions for BD, in a company news release.

“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. We also heard firsthand from customers that laboratory instruments have begun to manage them and their time instead of helping them improve efficiency of the lab. The fully automated BD COR System addresses these needs and gives control back to medical laboratory scientists.”

Beddard stressed that the system’s beauty is that it eliminates multiple interactions and allows large labs to gain the efficiencies.

“The PX, the instrument that manages the samples, 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. And the entire process offers full traceability via barcoding,” Beddard added.

According to the company, with this approval, the BD COR System offers two instruments: the BD COR PX instrument, which integrates and automates the sample workflow for diagnostic specimens and assays, and the PX instrument, which will prepare the samples by performing the appropriate pre-analytical processing steps and automatically deliver the samples to the GX instrument for analysis. The GX instrument will perform the analytical steps of the BD Onclarity HPV Assay, including extraction, amplification and detection.