Frequently Asked Questions

OncoK9 is a multi-cancer detection test for the detection and characterization of cancer-associated genomic alterations in DNA isolated from canine whole blood samples, using next-generation sequencing (NGS) technology. OncoK9 is intended for use in dogs who are at higher risk of cancer. It is recommended as an annual screening test for all dogs starting at 7 years of age, and starting at younger ages for dogs belonging to breeds in which cancer tends to develop earlier in life. It is also recommended as an aid-in-diagnosis test for dogs in which cancer is suspected based on clinical signs or other clinical findings. It is also recommended as a test for detection of residual disease following excisional surgery, and detection of recurrence following treatment, in dogs previously diagnosed with cancer. OncoK9 is intended for use alongside, not in place of, a through physical exam, clinical history, traditional tissue testing, and other diagnostics as recommended by the veterinarian.

As with any laboratory test, OncoK9 results should be interpreted by a veterinarian in the context of each patient’s medical history and clinical presentation. Please see the OncoK9 Product Insert for a list of contraindications and other important information.

OncoK9 is recommended as an annual screening test for all dogs starting at 7 years of age and starting at younger ages for dogs belonging to breeds in which cancer tends to develop earlier in life. The OncoK9 Cancer SAFE^™ tool can be used as a starting point to determine the age at which it may be appropriate to begin annual cancer screening for your patient based on breed or size. Click here to visit the OncoK9 Cancer SAFE tool. If cancer is clinically suspected, you may decide to use OncoK9 as an Aid-in-Diagnosis tool at a younger age. Please see the OncoK9 Product Insert for a list of contraindications and other important information.

Many of us participate in routine cancer screening as recommended by our own doctors. These routine screening tests in people (such as mammograms, colonoscopies, etc.) have contributed to reductions in mortality from several cancer types (breast, lung, colon, prostate, and cervical cancer).

Unfortunately, in dogs, cancer often goes undetected until it is large and/or widespread in the body, which can limit treatment options. Early cancer detection can be thought of as either early-stage detection and/or early clinical detection (prior to the development of clinical signs). For canine patients, in some cases, early-stage detection while the tumor is still localized to the primary site may allow for treatment with curative intent. In other cases, early clinical detection can allow treatment to be started while the patient is feeling well, potentially giving the family more time and options, and treatment may result in a better outcome. For example, when a dog is diagnosed with lymphoma (substage a) before they exhibit clinical signs of the disease (substage b), they tend to have a better prognosis than those dogs diagnosed after developing signs.

OncoK9 is a multi-cancer detection test, designed to detect multiple classes of genomic alterations associated with a wide variety of cancers. This means that with just a blood sample, we can look for a cancer signal originating from many different types of cancer including some of the most common cancers seen in practice: lymphoma, osteosarcoma, hemangiosarcoma, histiocytic sarcoma, mammary gland carcinoma, malignant melanoma, mast cell tumors, soft tissue sarcoma and anal sac adenocarcinoma. In the clinical validation study, OncoK9 detected 30 different cancer types, the list of which can be found here.

OncoK9 looks for cancer-associated genomic alterations in a sample. If these are found, a Cancer Signal Detected (positive) report is issued. Samples in which no cancer-associated genomic alterations are identified are reported as Cancer Signal Not Detected (negative). The test does not provide a definitive cancer diagnosis, and it should never be used as the sole basis for making important decisions such as treatment or euthanasia. A full clinical evaluation should be performed to establish a definitive diagnosis. Similarly, this test does not provide information about a patient’s genetic risk for developing cancer or other clinical conditions in the future. The results only indicate the detection or non-detection of cancer signal in the patient’s blood at the time of the blood draw.

In addition to a Cancer Signal Detected result, a cancer signal origin prediction can be provided for approximately half of hematologic malignancy (lymphoma and leukemia) cases.

A Cancer Signal Not Detected (negative) result indicates that no cancer-associated genomic alterations were detected in the sample. This significantly reduces the likelihood that cancer is present but does not rule out the presence of cancer or the possibility of cancer developing in the future. If cancer is clinically suspected, a full diagnostic evaluation should be performed.

When discussing a patient’s test result, it is important to consider the patient’s unique clinical context. The Negative Predictive Value (NPV) of a test is a measure of the likelihood that an individual with a negative test result is in fact NOT affected with the condition. NPV is impacted by the sensitivity and specificity of the test as well as patient’s prior probability of having the condition. Data was analyzed from 1,500 consecutive blood samples submitted to PetDx for liquid biopsy testing. Clinical outcomes could be assigned for 286 dogs with samples submitted for routine screening. The NPV in the screening population was 94.2%, meaning that the vast majority of patients that received a negative result from liquid biopsy testing had not been diagnosed with cancer as of the time the study outcome collection concluded. For the 127 patients that had a test run as an Aid-In Diagnosis where a clinical outcome could be assigned, the NPV was 67.5%.

For more information on this analysis including the Positive Predictive Value (PPV) observed in this study, please see the 2023 Journal of the American Veterinary Medical Association (JAVMA) article Clinical experience with next-generation sequencing–based liquid biopsy testing for cancer detection in dogs: a review of 1,500 consecutive clinical cases.

For more information on positive and negative predictive values, visit our test interpretation guide.

A Cancer Signal Detected (positive) result indicates that cancer-associated genomic alterations indicative of the presence of cancer were detected in the sample. This significantly increases the likelihood that cancer is present but does not confirm the presence of cancer. This result should not be used as the sole basis for making important decisions such as treatment or euthanasia. A confirmatory cancer evaluation should be performed to establish a definitive diagnosis. This may include a thorough clinical history and physical exam (including an oral and rectal exam), complete bloodwork and urinalysis, routine imaging (such as thoracic radiographs, abdominal ultrasound, and radiographs of any localized areas of bone or joint pain), tissue sampling of any detected masses (including enlarged lymph nodes) for pathologic analysis, and, in rare cases, advanced imaging such as echocardiogram, CT or MRI. The need for a confirmatory evaluation following a positive result is not unlike some of the cancer screening tests in people. For example, an abnormal mammogram is not the sole reason to start treatment but is instead a sign that further work up is needed.

When discussing a Cancer Signal Detected result with an owner, the unique clinical context of the patient needs to be considered. The Positive Predictive Value (PPV) of the test is a measure of the likelihood that an individual with a positive test result is in fact affected with the condition. The PPV is reflective of not only the sensitivity and specificity of the test, but the patient’s prior probability of having the condition. Data was analyzed from 1500 consecutive blood samples submitted to PetDx for liquid biopsy testing. A clinical outcome could be assigned for 286 patients with samples submitted for routine screening. The relative observed PPV in this group was 75%, meaning that cancer was found in three quarters of screening patients that received a positive result from liquid biopsy testing following a confirmatory cancer evaluation. A clinical outcome could be assigned to 127 patients with samples submitted as an aid-in-diagnosis. The relative observed PPV in this group was 97.7%, meaning that cancer was found in nearly 98% of patients who received a positive result from liquid biopsy testing following a confirmatory cancer evaluation.

For more information on this analysis including the Negative Predictive Value (NPV) observed in this study, please see the 2023 Journal of the American Veterinary Medical Association (JAVMA) article Clinical experience with next-generation sequencing–based liquid biopsy testing for cancer detection in dogs: a review of 1,500 consecutive clinical cases.

For more information on positive and negative predictive values, visit our test interpretation guide.

We encourage veterinarians to reach out to PetDx Clinical Support with questions or for case consultation. They can be reached at or (833)-464-7297.

Each case is different, and follow-up diagnostic workup is at the discretion of the veterinarian. A cancer-focused clinical evaluation is advised, with a thorough physical exam (including oral and rectal exam), clinical history, routine imaging (such as thoracic radiographs, abdominal ultrasound, and radiographs of any localized areas of bone or joint pain), and sampling of any masses or enlarged lymph nodes found on exam or workup. Advanced imaging such as echocardiogram, CT, or MRI may also be indicated in rare cases.

We encourage veterinarians to reach out to PetDx Clinical Support with questions or for case consultation. They can be reached at or (833)-464-7297.

If you have questions or need help interpreting test results, please contact the PetDx Clinical Support team and we will be happy to assist you further. Our team can be reached at or (833)-464-7297.

OncoK9 is only available by or on the order of a veterinarian. Specialized blood tubes are required to stabilize samples used to run OncoK9, and these tubes are supplied along with blood collection materials in a kit. Veterinarians in North America may order directly from PetDx or through our diagnostic distribution partners (Antech and IDEXX). Veterinarians in Hong Kong, Singapore, Malaysia, South Korea and Cambodia can order through Asia Veterinary Diagnostics.

PetDx

If you are a veterinarian interested in offering OncoK9 to your patients, please email our sales team to set up an account directly with PetDx.

Antech North America

USA Test Code: S14493

CANADA Test Code: CS14493

To learn more about ordering, contact your Antech representative.

(800) 872-1001
antechdiagnostics.com

Asia Veterinary Diagnositcs by Antech

Test Code: S14493

To learn more about ordering, contact your AVD representative.

Hong Kong: +852 2371 0080
Malaysia: +852 9118 7047
Hong Kong: +65 6291 5412

IDEXX Reference Laboratories

USA Test Code: 8972

CANADA Test Code: ONCOK9

To learn more about ordering, contact your IDEXX representative

(800) 726-1212
idexx.com

OncoK9 is available by setting up a direct account with PetDx or through one of our partners, IDEXX or Antech. If you have a direct account set up with PetDx, please refer to your pricing agreement for specific details. For questions on setting up a direct account please contact . If you plan on utilizing OncoK9 through Antech or IDEXX, please reach out to their customer service or company representative for pricing.

No, the patient does not have to be fasted in order to have a sample drawn for OncoK9. For a list of contraindications to running OncoK9 along with other important information, please visit the OncoK9 Product Insert.

OncoK9 can be a useful Aid-In-Diagnosis tool in the work up of sick patients. In the CANDiD study, patients were not excluded for having concurrent diseases. This test utilizes next-generation sequencing and bioinformatics to look for cancer-associated genomic alterations, delivering high specificity (98.5%) for cancer detection. Conditions such as inflammation, autoimmune or metabolic disorders are not expected to cause false positive results. As with any lab test, results should be interpreted by a veterinarian. For a list of contraindications to running OncoK9 along with other important information, please visit the OncoK9 Product Insert.

Your OncoK9 kit contains blood sample collection materials in addition to the specialized blood tubes. Once filled between the two black fill lines printed on the tubes’ label (a minimum of 7ml in each tube), blood tubes should be gently inverted 8-10 times. There is no additional processing. See the OncoK9 Product Insert for sample storage, shipping and handling considerations and other important information.

We are always optimizing the laboratory process and our current turnaround time is 7-12 calendar days from the day the sample is received at the laboratory to the time a test report is issued. Occasionally, the laboratory may determine that a sample requires additional processing or reanalysis, and these exceptions will add to the sample turnaround time.