Clinical validation study for pioneering early cancer detection test for dogs is published

A clinical validation study demonstrating the ability of a novel liquid biopsy test for dogs (OncoK9; PetDx) to detect multiple cancers in canines, using next-generation sequencing (NGS) has been published in PLOS One, a peer-reviewed, open-access scientific journal from the Public Library of Science. The publication details results of the CANcer Detection in Dogs (CANDiD) study, which is the largest clinical validation study ever performed in veterinary cancer diagnostics, according to PetDx.¹

“This landmark study, and our rich [research and development] pipeline in veterinary oncology, underscore our commitment to building PetDx into the world’s leading veterinary cancer diagnostics company,” said Daniel S. Grosu, MD, MBA, founder and CEO of PetDx, in an organizational press release.¹

According to the National Cancer Institute, there are approximately 6 million new cases diagnosed each year in a population of approximately 65 million dogs in the United States.² There are no established cancer screening guidelines for dogs, and many cases are diagnosed only when dogs start to show clinical signs, by which time the cancer is often advanced and the chances of achieving a cure or long-term control are low.¹

Canine cancer is typically diagnosed because of the presence of clinical signs, at which point cancer is often at an advanced stage, making the prognosis poor and the case more challenging to manage, according to Andi Flory, DVM, DACVIM (Oncology), chief medical officer at PetDx and the study’s lead author, in a session presentation at the Fetch dvm360® Conference in San Diego, California, in December 2021. Flory also discussed how improved patient outcomes may be achieved with early cancer identification and treatment for the disease with liquid biopsy testing. She noted that despite the need, cancer screening paradigms do not exist for dogs, like they do for humans.³

“Unfortunately, in veterinary medicine, cancer screening guidelines are lacking,” said Flory.³

Annual or biannual physical exams and routine minimum database testing such as chemistry and urinalysis are unable to detect many cancers in dogs, Flory added, during the Fetch session, but noninvasive liquid biopsies that focus on high-risk canine populations, including older dogs and predisposed breeds, may help identify cancer at an earlier stage.³

OncoK9 mirrors leading multi-cancer early detection (MCED) tests for humans and relies on a blood draw to obtain a DNA sample. NGS is used to detect certain types of cancer in dogs through their DNA.¹

The results of the newly published CANDiD study demonstrated OncoK9’s ability to detect cancer-associated genomic alterations in canine patients across a large and diverse set of 30 cancer types.The study demonstrated sensitivity of 85.4% for 3 of the most aggressive canine cancers—lymphoma, hemangiosarcoma and osteosarcoma—and detection was also particularly high for the 8 most common cancer types found in dogs. The study results showed that OncoK9 has an overall sensitivity of 54.7%, at a specificity of 98.5% (corresponding to a false positive rate of just 1.5%) and, in some cases, cancer was detected many months prior to the onset of clinical signs.^1,4

As a veterinary diagnostic tool, this type of noninvasive testing may enable earlier cancer detection in screening and aid-in-diagnosis clinical scenarios, potentially leading to a paradigm shift in the way cancer is diagnosed and managed in dogs, according to CANDiD investigators.⁴

“Early detection has been shown to drive better clinical outcomes in humans such as increased life expectancy and higher rates of achieving cure or long-term control following curative-intent interventions. It stands to reason those similar benefits could be achieved in canine patients with the availability of early detection screening tools,” said Flory.³

The CANDiD study was performed on blood samples collected prospectively from more than 1000 client-owned dogs at more than 40 clinical sites across the United States, Canada, Brazil, the Netherlands, France, and Hong Kong between 2019 and 2021.^1,4

“The pace of enrollment into this study across the globe was truly inspiring. Dog owners as well as veterinarians are eager to have a noninvasive 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 incorporated as part of preventive care, can improve cancer outcomes and may shorten the path to diagnosis in clinically challenging cases,” said Flory in an organizational press release.¹

At PetCure Oncology in Jacksonville, Florida—the study’s first clinical site—88 dogs enrolled in the study.¹

“My own dogs, Buccee and Bella, were the very first enrollees at our hospital, and they are proud to have contributed to such a monumental effort to help dogs with cancer,” said Tracy LaDue, DVM, DACVIM (Oncology), DACVR (Radiation Oncology), medical and radiation oncologist at PetCure Oncology, and Southeast Veterinary Oncology and Internal Medicine, Orange Park, Florida, in the press release.¹

OncoK9 is currently recommended as an annual screening test for dogs at higher risk of cancer due to age and/or breed, and as an aid-in-diagnosis for dogs in which cancer is suspected based on clinical signs or other clinical findings. Given the prevalence of cancer in these canine patient populations, the test’s positive predictive value (PPV) is estimated to be 76-80% in the screening use case and 94-97% in the aid-in-diagnosis use case. Further studies are underway to support the application of the test in additional use cases, including minimal residual disease detection, recurrence monitoring, treatment response monitoring, and targeted treatment selection.¹

“During the past decade, novel genomic testing solutions using liquid biopsy technology have catalyzed paradigm shifts in multiple areas of human medicine, such as oncology, obstetrics, infectious disease, and organ transplantation. Our team is delighted to bring this revolutionary innovation to veterinary medicine, starting with a detection solution for cancer—the biggest health threat faced by humanity’s best friends,” said Dana Tsui, PhD, chief scientific officer at PetDx and the study’s senior author, in the press release.¹

Since its launch in 2021, the OncoK9 liquid biopsy test has been successfully integrated into routine testing at many hundreds of leading veterinary practices nationwide as a new preventive care and aid-in-diagnosis tool, according to PetDX. Blood samples from all over the country are being shipped daily to the PetDx central laboratory in San Diego, and results are delivered to ordering veterinarians within 10 business days.¹

The test is available at veterinary clinics in the United States and Canada through PetDx and IDEXX Reference Laboratories.¹

References

1. PetDx® announces publication of landmark clinical validation study for OncoK9®, its pioneering multi-cancer early detection test for dogs using next-generation sequencing. News release. April 26, 2022. Accessed April 26, 2022. [email]
2. What is comparative oncology? National Cancer Institute: Center for Cancer Research. Accessed April 26, 2022. https://ccr.cancer.gov/Comparative-Oncology-Program/pet-owners/what-is-comp-onc
3. Flory A. Liquid biopsies for noninvasive multicancer detection in dogs. Presented at: Fetch dvm360® Conference; San Diego, California. December 2-5, 2021.
4. Flory A, Kruglyak KM, Tynan JA, et al. Clinical validation of a next-generation sequencing based multi-cancer early detection “liquid biopsy” blood test in over 1,000 dogs using an independent testing set: The CANcer Detection in Dogs (CANDiD) study. PLoS ONE. 2022;17(4): e0266623. https://doi.org/10.1371/journal.pone.0266623