Summary: PharusDx announces the OncoSweep Pancreas Spotlight, a liquid biopsy test that uses microRNA and CA19-9 biomarkers to detect early-stage pancreatic cancer, offering new hope for individuals at elevated risk.

Three Key Takeaways

  1. Revolutionizing Early Detection: The OncoSweep Pancreas Spotlight test combines microRNA analysis with CA19-9 biomarker detection, offering a non-invasive and accurate method to screen for pancreatic ductal adenocarcinoma (PDAC) in at-risk populations.
  2. Partnership with City of Hope: PharusDx’s test builds on groundbreaking research led by City of Hope, leveraging a proprietary microRNA biomarker panel to translate academic discoveries into a validated laboratory-developed test (LDT).
  3. Improving Survival Rates: By enabling early detection of PDAC, the test has the potential to significantly increase five-year survival rates, particularly when the disease is diagnosed at stage I, where surgical interventions are more effective.

Pharus Diagnostics, a provider of non-invasive diagnostic tests, announced a significant step forward in the fight against pancreatic cancer. The company is announcing availability of its OncoSweep Pancreas Spotlight, a liquid biopsy screening test that aids in the detection of Pancreatic Ductal Adenocarcinoma (PDAC) in people with elevated risk. 

Pancreatic Cancer Blood Testing

The test uses a simple blood sample, next-generation sequencing, and a proprietary machine-learning pipeline to analyze levels of microRNA and CA19-9 biomarkers.

PharusDx’s new OncoSweep Pancreas Spotlight LDT has the potential to significantly improve outcomes by offering a non-invasive and accurate screening method for early-detection. The development of this LDT, in conjunction with PacificDx (a CLIA-accredited laboratory) in Irvine, California, aligns with PharusDx’s commitment to advancing early cancer detection. By offering a simple blood test for PDAC, the company aims to empower individuals at risk for the disease to undergo regular monitoring to detect early-stage disease when they have the most options for treatment.

Developing a Brighter Future for Patients

In January of 2024, PharusDx entered into an exclusive global licensing agreement with City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with a Los Angeles comprehensive cancer center ranked among the nation’s top 5 cancer centers by U.S. News & World Report, for a proprietary panel of microRNA (miRNA) biomarkers with testing data demonstrating potential value for early detection of PDAC. 

OncoSweep Pancreas Spotlight builds on the biomarker panel and approach from City of Hope, moving the translational academic findings into a Laboratory Developed Test (LDT). This effort leverages PharusDx’s OncoSweep liquid biopsy platform and City of Hope’s early cancer detection research led by Ajay Goel, PhD, Chair of City of Hope’s Department of Molecular Diagnostics and Experimental Therapeutics.

“We have been hard at work validating our pancreatic cancer miRNA biomarker panel and have now completed CLIA[1] LDT validation of our test, an exciting milestone for the company and people at-risk who have limited options for early detection of this devastating disease,” says CEO Philip Huang.

Combating Pancreatic Ductal Adenocarcinoma

PDAC is an aggressive form of cancer with a dismal prognosis. Due to its location within the body and lack of early symptoms, the disease is often diagnosed at an advanced stage, significantly reducing survival rates. Most PDAC is detected at stage IV when there is just a 3%[2],[3] five-year survival rate. If the disease is caught at stage I, the five-year survival jumps to over 40%[2], a greater than 10-fold increase. Those at increased risk for PDAC include people with Lynch syndrome, Peutz-Jeghers syndrome, new-onset diabetes (after 50 yrs old), pancreatic cysts, chronic pancreatitis, certain mutations in BRCA1/2, PRSS1, ATM, TP53, those with first degree relatives as well as those with certain lifestyle risk factors such as smoking, alcohol abuse, or obesity.

“We are thrilled to bring this potentially life-saving technology developed by PharusDx, based on translational research findings from City of Hope, to market,” says Bowei Lee, Chairman of PharusDx. “An accurate early detection tool can significantly improve outcomes for people with PDAC, particularly when surgical intervention remains a viable option.”

References and Notes:

  1. Clinical Laboratory Improvement Amendments
  2. https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html
  3. https://www.hopkinsmedicine.org/health/conditions-and-diseases/pancreatic-cancer/pancreatic-cancer-prognosis