Frequently Asked Questions

A Cancer Signal Detected result indicates that cancer-associated genomic alterations 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 full clinical evaluation must be performed to establish a definitive diagnosis.

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. See our test interpretation guide for a more detailed explanation of PPV. If the patient was tested due to existing clinical signs and a suspicion of cancer, the PPV is likely to be much higher than if the test were ordered as a screening test with a much lower pre-existing chance of cancer. In any case, a Cancer Signal Detected result significantly increases the likelihood that cancer is present, and additional clinical evaluation is indicated.

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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), thoracic and abdominal imaging, and sampling of any masses or enlarged lymph nodes found on exam or workup. Advanced imaging such as CT, MRI, or PET or other diagnostics may also be indicated.

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If the clinical evaluation does not result in a cancer diagnosis, this could mean that the selected confirmatory tests did not identify the cancer, or that the test result was a false positive. Advanced or confirmatory diagnostics, such as ultrasound, CT, or tissue sampling of any masses or enlarged lymph nodes, if not already performed, are advised. Further evaluation and/or monitoring of this patient should be considered. A retest with OncoK9 may be offered; we encourage clinicians in this situation to contact our team for support and to discuss eligibility.

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OncoK9 is a multi-cancer early detection test meaning it detects multiple classes of genomic alterations associated with a wide variety of cancers. You can view a list here of the 30 different cancers that OncoK9 detected in at least one affected patient in the clinical validation study. View this information at the PetDx Veterinary Support website.

OncoK9 has been designed to detect cancer-associated genomic alterations that are present even in very early-stage cancers. As a result, OncoK9 may detect cancer early, while it is still localized to the primary site and can be treated with curative intent. A positive test result indicates the presence of malignant tumor in the body. The fraction of cancer cases detectable by the test increases with cancer stage. When used for Screening in patients without clinical signs suggestive of cancer, repeat testing at annual intervals will increase the likelihood of detecting cancer by OncoK9.

No. OncoK9 is indicated for use in domestic canids only (pet dogs). Dogs and cats have unique genomes. OncoK9 has been uniquely designed to only work in dogs. In the future, we hope to be able to extend this technology to cats with a separate product.

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It is not necessary to do anything special to prepare the sample for shipment in relation to climate temperatures. Simply follow the standard procedures and use the shipping supplies provided in the OncoK9 test kit. Please keep the sample indoors until it is handed off to FedEx®. Do not set it outside for the courier to pick up.

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It is winter and the temperature is below 65°F/18°C.
It is summer and the temperature is above 77°F/25°C.

Sedatives and/or anesthetics are not expected to impact the OncoK9 test. If the pet is scheduled to have surgery and samples are to be collected in the peri-operative time period, it is acceptable to collect samples after the pet is intubated and anesthetized but BEFORE any surgical incision has been made, as this may release large amounts of cell-free DNA into circulation, which could impair the test’s performance.

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OncoK9 is only available by prescription. Veterinarians in North America may order directly from PetDx or through our partners.

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

To learn more about ordering, contact your Antech representative.

(800) 872-1001
antechdiagnostics.com

IDEXX Reference Laboratories

To learn more about ordering, contact your IDEXX representative

(800) 726-1212
idexx.com

During the contracting process, pricing will be determined based on multiple factors. Please contact for specific details.

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The blood collection tubes and needles included in the kits do expire. However, most kits will have a shelf life of at least 9 months when they are shipped to the clinic. In the event kits expire prior to use, we can send replacements. Please reach out to your PetDx Customer Success Manager, or contact a member of our support team at: , or call (833)-464-7297. You can also visit our Support Portal and submit a ticket with the details at: support.petdx.com. We will send you replacement kits and determine if the kits you have on hand need to be shipped back to us.

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The test is looking for cell-free DNA fragments that are present at very low concentrations in plasma. OncoK9 requires a 14-17mL blood volume in order to obtain sufficient cell-free DNA from a sample to meet our stringent quality control requirements.

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OncoK9 looks for cancer-associated genomic alterations in a sample and the findings are reported out in a qualitative manner. If cancer-associated genomic alterations are found, a Cancer Signal Detected report is issued. Samples in which no cancer-associated genomic alterations are identified are reported as Cancer Signal Not Detected. 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 present time.

Cancer Signal Origin (CSO) prediction has been validated for hematological malignancies, such as lymphoma, and research is ongoing to add cancer signal origin prediction for more cancer types. When the cancer signal is not indicative of hematological malignancy, the result is limited to a Cancer Signal Detected result and no CSO is provided. A veterinarian can use the provided information to guide their next steps.

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What type of results are provided?
Does OncoK9 determine the location of the cancer?

Conditions other than cancer are not known to be associated with acquired (“somatic”) alterations in DNA, so are unlikely to confound the results of OncoK9 testing. Dogs with a wide variety of non-cancer conditions were included in the all-comers cohort of “cancer-free” subjects in the OncoK9 validation study, which demonstrated a very low false positive rate of just 1.5%.

PetDx has multiple clinical studies ongoing. To learn more about participation in these studies, please visit the PetDx Clinical Studies web page.

All OncoK9 testing and interpretation steps are performed at the PetDx central laboratory in San Diego, California (ISO 9001:2015 Certificate Nr. 1807). Two state-of-the-art Illumina NovaSeq 6000 Next-Generation Sequencing instruments are used for the high complexity testing required to generate OncoK9 results.