Novel lower-cost blood test for cancer screening in dogs validated in large clinical study by PetDx

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Feb 09, 2024, 09:00 ET

Published in the Journal of the American Veterinary Medical Association (JAVMA), a PetDx^® study shows that the company's novel OncoK9^® Screen "liquid biopsy" blood test provides high sensitivity for seven common cancer types that are often difficult to detect in dogs by physical exam alone. By integrating cell-free DNA quantification and next-generation sequencing using a proprietary method, the new test can be performed faster and at lower cost than the company's flagship OncoK9^® Dx test, allowing for broader access to blood-based cancer screening in dogs.

SAN DIEGO, Feb. 9, 2024 /PRNewswire/ -- PetDx^® – The Liquid Biopsy Company for Pets™ published a clinical validation study this week showing that its new OncoK9^® Screen test has a high detection rate across seven predefined, clinically relevant cancer types that represent a large proportion of all cancers found in dogs and are often difficult to detect by physical exam alone due to their anatomic location and/or lack of specific clinical signs. These cancer types are often aggressive, requiring prompt intervention, and have typically been associated with improved outcomes when detected and treated early.

Appearing in the Journal of the American Veterinary Medical Association, the study evaluated nearly 2,000 dogs with and without cancer across independent training and testing cohorts (to mitigate the risk of data overfitting), making it by far the largest clinical validation study ever published for a cancer detection test in veterinary medicine. It demonstrated a sensitivity of over 70% for the OncoK9^® Screen test across seven cancer types (lymphoma, hemangiosarcoma, osteosarcoma, leukemia, histiocytic sarcoma, primary lung tumors, and urothelial carcinoma), with a low false positive rate of <1.5% in cancer-free dogs.

The OncoK9^® Screen test's proprietary algorithm analyzes cell-free DNA (cfDNA) quantification data to generate a final result of High or Low Probability of Cancer for approximately 90% of samples tested; the remaining samples are automatically reflexed to additional testing by next-generation sequencing (NGS) to arrive at a final result. Dogs do not have to be fasted prior to blood collection, and samples are sent directly to the PetDx lab in specialized tubes provided by the company, without any requirements for in-clinic processing.

"Previously published research has shown that only around 10% of cancer cases are currently detected in dogs prior to the onset of clinical signs. The OncoK9^® Screen test can act as a complement to the physical exam to increase the number and types of cancers detectable during routine wellness visits," said Andi Flory, DVM, DACVIM (Oncology), Chief Medical Officer at PetDx and the study's lead author. "The availability of comprehensively validated blood-based cancer detection tools that can be readily incorporated into preventive care protocols opens the door to the development of cancer screening guidelines for early cancer detection in dogs."

PetDx President and CEO Alejandro Bernal, DVM, MS, MBA, added that using only cfDNA quantification analysis for the vast majority of samples allows the OncoK9^® Screen test to be performed at a much lower cost and with a shorter turnaround time than the company's flagship test, which is now designated as OncoK9^® Dx. "The addition of OncoK9^® Screen to our portfolio of non-invasive liquid biopsy tests is intended to make early cancer detection more accessible to veterinarians and pet owners and highlights the company's relentless commitment to innovation in an area of considerable unmet need in veterinary medicine," he said.

About PetDx
PetDx® – The Liquid Biopsy Company for Pets™ is a San Diego-based molecular diagnostics company dedicated to unleashing the power of genomics to improve pet health. The company's portfolio of "liquid biopsy" multi-cancer early detection (MCED) blood tests includes two pioneering solutions (OncoK9^® Screen and OncoK9^® Dx) that have been extensively validated in large clinical studies published by leading peer-reviewed journals. Both tests enable veterinarians to detect cancer in dogs with a simple blood draw. To learn more, visit PetDx.com, OncoK9.com, and connect with us on Facebook, Instagram, LinkedIn, and X.

SOURCE PetDx