Pharus Diagnostics LLC Announces Validation of a Laboratory-Developed Test for Early Pancreatic Cancer Detection

Pharus Diagnostics LLC. (PharusDx), an innovator in non-invasive diagnostic tests, today 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. 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.

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 groundbreaking early cancer detection research led by Dr. Ajay Goel, 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" explained CEO Philip Huang.

"We are thrilled to bring this potentially life-saving technology developed by PharusDx, based on translational research findings from City of Hope, to market," said 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."

Combating a Deadly Disease

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.

A Brighter Future for Patients

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.

About PharusDx

PharusDx is at the forefront of healthcare innovation, specializing in advanced diagnostic technologies. Founded in 2022, our mission is to detect cancer early to help provide more treatment options and improve patient outcomes. Our focus is to create exceptionally precise and accurate tests by integrating liquid biopsies, advanced biomarkers and machine learning. OncoSweep™ early detection tests are designed to be convenient and accessible, with the patient always at the center.

Conflict of Interest Statement: Dr. Goel is a compensated PharusDX advisory board member and as an inventor of the technology licensed to the company by City of Hope, is entitled to royalty payments from the company.

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