PetDx® Announces Publication of Landmark Clinical Validation Study for OncoK9®, Its Pioneering Multi-Cancer Early Detection Test for Dogs Using Next-Generation Sequencing

Published in PLOS ONE, the CANcer Detection in Dogs (CANDiD) study – the largest clinical validation study in veterinary cancer diagnosis – sets a new benchmark for veterinary medicine

SAN DIEGO, April 26, 2022 /PRNewswire/ — PetDx® – The Liquid Biopsy Company for Pets™ today announced the release of a landmark study in PLOS ONE, a peer-reviewed open access scientific journal from the Public Library of Science. Publication Details Largest Clinical Validation Study Ever in Veterinary Cancer Diagnosis and Demonstrates that OncoK9® – The Liquid Biopsy Test for Dogs™ Performance Mirrors Leading Multi-Cancer Early Detection (MCED) Tests for the man.

PetDx (PRNewsfoto/PetDx)

The CANcer Detection in Dogs (CANDiD) study, an international multicenter clinical study, was designed to validate the performance of OncoK9, a novel MCED test for dogs using next-generation sequencing (NGS) of blood-derived DNA.

“PetDx has made an unprecedented investment over the past few years to develop and validate a blood test for the detection and characterization of cancer in our canine companions. This landmark study and our rich R&D pipeline in veterinary oncology underscores our commitment to making PetDx the world leader in veterinary cancer diagnostics,” said Daniel S. GrosuMD, MBA, Founder and CEO of PetDx.

The study was performed on blood samples prospectively collected from more than 1,000 customer-owned dogs at more than 40 clinical sites across United States, Canada, Brazil, the Netherlands, Franceand hong kong between 2019 and 2021. The results demonstrated the ability of the test to detect 30 different types of canine cancer, with a sensitivity of 85.4% for three of the most aggressive canine cancers (lymphoma, hemangiosarcoma and osteosarcoma) and an overall sensitivity of 54.7%, at a specificity of 98.5% (corresponding to a false positive rate of only 1.5%).

“The pace of enrollment in this study around the world was truly inspiring: dog owners as well as veterinarians are eager to take a non-invasive cancer detection test and were happy that their dogs could be part of this groundbreaking research. Having this new tool in the toolbox is incredibly exciting for veterinarians, earlier detection, when integrated as part of preventative care, can improve cancer outcomes and can shorten the path to diagnosis in clinically difficult cases,” said Andi FloryDVM, DACVIM (oncology), chief medical officer at PetDx and lead study author.

Cancer is by far the leading cause of death in dogs, with approximately 6 million new cases diagnosed each year in a population of approximately 90 million pet dogs in United States. Currently, there are no established guidelines for cancer screening in dogs, and the majority of cases are not diagnosed until dogs begin to show clinical signs, at which time the cancer is often advanced. and the chances of recovery or long-term control are low.

“Our clinic was honored to participate in the CANDiD study, which we found to be a meticulously executed prospective collection study that dog parents were truly excited to participate in. My own dogs, Buccee and Bella, were the very first registered at our hospital, and they are proud to have contributed to such a monumental effort to help dogs with cancer,” said Tracy LaDueDVM, DACVIM (oncology), DACVR (radiation oncology), medical oncologist and radiation oncologist at Southeast Veterinary Oncology and Internal Medicine and PetCure Oncology, Jacksonville, Florida.which was the first clinical site of the study and recruited 88 dogs.

OncoK9, the first and only “liquid biopsy” test for detecting cancer-associated genomic alterations in veterinary patients, is currently recommended as an annual screening test for dogs at high risk for cancer due to their age and/or of their breed, and as a diagnostic aid test for dogs in which cancer is suspected on the basis of clinical signs or other clinical findings. Given the prevalence of cancer in these canine patient populations, the positive predictive value (PPV) of the test – which describes the likelihood that a patient with a positive OncoK9 result will in fact have cancer – is estimated at 76-80% in the use of screening. cases and 94-97% in the case of diagnostic aid use. Further studies are underway to support application of the test in additional use cases, including minimal detection of residual disease, monitoring of recurrence, monitoring of treatment response, and targeted selection of the treatment.

“Over the past decade, new genomic testing solutions using liquid biopsy technology have catalyzed paradigm shifts in multiple areas of human medicine, such as oncology, obstetrics, infectious diseases and organ transplantation. Our team is excited to bring this revolutionary innovation to veterinary medicine. , starting with a solution for detecting cancer, the greatest health threat facing humanity’s best friends,” said Dana TsuPhD, scientific director of PetDx and lead author of the study.

Since its launch in 2021, the OncoK9 liquid biopsy test has been successfully incorporated into the routine testing of several hundred leading veterinary practices nationwide as a new preventive care and diagnostic aid tool. . Today, blood samples from across the country are shipped daily to PetDx’s central lab in San Diego, and the results are delivered to the ordering veterinarians within 10 working days. The test is available at veterinary clinics in United States and Canada via PetDx and IDEXX reference labs.

About PetDx

PetDx® – The Liquid Biopsy Company for Pets™ is a San Diegois a London-based molecular diagnostics company dedicated to unlocking the power of genomics to improve companion animal health. The company’s flagship product, OncoK9®, enables veterinarians to detect cancer in dogs through a simple blood test. As the first multi-cancer early detection (MCED) test, OncoK9 uses state-of-the-art genomic analysis that leverages next-generation sequencing (NGS) technology and proprietary bioinformatics algorithms, enabling veterinarians to deliver superior care to canine patients. To learn more, visit www.petdx.com and join us on Facebook, instagram, LinkedInand Twitter.

Contact: [email protected]

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Jacob L. Thornton