NEW YORK — Breakthrough Genomics said Thursday that it has partnered with the Pancreatic Cancer Early Detection (PRECEDE) Consortium on the validation of the company's liquid biopsy test for the early detection of pancreatic cancer.
Breakthrough's blood-based test, called BT-Reveal, is a next-generation sequencing-based assay designed to detect specific DNA methylation haplotype blocks in cell-free tumor DNA fragments that are associated with pancreatic cancer. It received US Food and Drug Administration breakthrough device designation in early 2023 and has been clinically validated to detect early-stage and late-stage pancreatic ductal adenocarcinoma, according to the Irvine, California-based company. It is currently offered by Breakthrough's CAP- and CLIA-certified clinical lab.
Through the alliance, Breakthrough will gain access to PRECEDE's network of pancreatic cancer researchers and experts. The consortium is currently conducting a longitudinal study involving over 7,000 pancreatic cancer patients across 54 institutions that Breakthrough will now participate in. "With access to the distinct cohorts of patients enrolled in the study, we will be able to further validate the test's performance across a number of different high risk groups including those with an inherited genetic predisposition and those with a family history of pancreatic cancer," a company spokesperson said in an email.
About a year ago, the PRECEDE Consortium began working with Biological Dynamics to validate an exosome-derived blood-based test for pancreatic cancer.
Breakthrough Genomics was founded in 2016 as a provider of genomic data analysis and interpretation services. In 2020, it began offering a research-use-only coronavirus susceptibility assessment in response to the COVID-19 pandemic. It also markets a blood-based colorectal cancer test, along with genetic tests for a range of diseases.