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“Early detection and treatment are the best ways to manage cancer in pets… cancer is frequently treatable and early diagnosis will aid your veterinarian in delivering the best care possible.”

— American Veterinary Medical Association

OncoGx16 & OncoGuarDx Can Help Safeguard Furry Kids from Cancers

What is cancer screening?

Cancer screening refers to exams or tests performed on someone who does not currently have any signs of cancer, but who does have a higher risk of cancer due to age and/or breed.

What are the benefits of early screening?

Early treatments are the best ways to manage cancer. Cancer is frequently treatable and early diagnosis will aid your veterinarian in delivering the best care possible.

What are the current guidelines for cancer screening?

Screening guidelines are well established in human medicine for various cancer types. Yet formal cancer screening guidelines have not yet been established in veterinary medicine. General health screening recommendations include annual or biannual exams and routine lab works which may detect some cancer types.

Which dogs have urgent need for cancer screening?

Dogs at higher risk of cancer or over age 7.  Certain breeds have a higher lifetime risk of cancer, and some breeds also have a higher risk of being diagnosed at an earlier age.  However, older dogs are at higher risk of cancer, regardless of breed.

Can OncoGx16 detect specific type of cancer?

YES! OncoGx16 test detects up to 16 types of specific canine cancer, which are conveniently divided in two separate panels.  The first panel includes Anal sac adenocarcinoma, Ceruminous adenocarcinoma, Mammary gland carcinoma, Mast cell tumors, Melanoma, Nasal squamous & adenocarcinoma, Oral tumors, and Olfactory neuroblastoma. The second panel includes hemangiosarcoma, Lung adenocarcinoma, Canine lymphoma, Osteosarcoma, Prostate carcinoma, Renal cell carcinoma, Thyroid carcinoma and Transitional cell carcinoma.

A positive test result for the first panel indicates at least one of the eight types of malignant tumor in the first panel is present in the body.  A positive test result for the second panel indicates at least one of the eight types of malignant tumor in the second panel is present in the body. 

How accurate is the OncoGx16 test? What is its sensitivity?

The performance characteristics of the OncoGx16 were determined in validated cohorts comprising over 300 dogs, with and without a diagnosis of cancer, in which 16 types of canine cancers are demonstrated with overall sensitivity and specificity of 98% and 99.5% respectively.

What is the false positive rate for the OncoGx16 test?

The false positive rate was less than 0.5% as the test had greater than 99.5% specificity. This means that, out of 100 subjects believed to be cancer-free, 1 subject (0.5 mathematically speaking) may have a positive test result.

How early can OncoGx16 detect cancer?

OncoGx16 is designed to detect cancer-associated DNA epigenetic signals that are present at early-stage cancers. As a result, OncoGx16 may detect in situ carcinoma, while cancer is still localized to the primary site.  

What type of results are provided?

OncoGx16 test is a bi-lateral flow molecular assay with dual result windows to display qualitative results in a color-coded manner.  If cancer signal is detected, then at least one of the windows will turn red.  If cancer signal is not detected, then both windows will turn green.  The results only indicate the detection or non-detection of cancer signal for the targeted 16 types of cancers in the patient’s DNA at the present time, 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.

What should I do when my pet’s test result is positive?

At the discretion of the veterinarian, a follow-up diagnostic workup is recommended. An oncology clinical evaluation includes 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 designated.

How should a negative test result be interpreted?

A negative test result indicates that no malignancy-associated conformational alterations were detected in the sample for the targeted 16 types of cancer. This significantly reduces the likelihood that any of the 16 types of cancer is present, but does not rule out the presence of additional non-targeted cancers or the possibility of cancer developing in the future. If clinical suspicion remains, a full diagnostic evaluation should be performed.

Why does a positive test result from OncoGx16 require further diagnostic testing for confirmation?

To arrive at a definitive diagnosis, it is necessary to confirm diagnostic test results with an established method (such as tissue biopsy). The OncoGx16 test alone does not provide a diagnosis of cancer and is meant to be used alongside existing clinical evaluation.

How often should a patient be retested with OncoGx16 after a negative test result?

If the OncoGx16 test is being used in a patient that is not suspected of having cancer but in which screening is recommended due to age or high-risk breed, performing an OncoGx16 test semi-annually is recommended.

How often should OncoGx16 be used for cancer screening?

Screening should be performed at regular intervals over time, with the goal of identifying cancer earlier. Since dog ages ~7 times faster than human, we recommend semi-annual screening of dogs that are 7 years and older. Certain breeds that are predisposed to cancer may benefit from starting screening at a younger age.

What is OncoGx16?

OncoGx16 is a first-in-class test specifically developed to detect cancer at home.  The test only requires a simple nose philtrum swab sample and can take place anywhere, anytime for any breed without fasting or any restrictive conditions.

What types of cancer can OncoGx16 detect?

OncoGx16 is a multi-cancer early detection test meaning it detects multiple types of cancers. You can view a list here of cancer types specifically formulated for the OncoGx16 Test Kit.

What type of DNA is OncoGx16 testing? What is exosome DNA?

OncoGx16 is a philtrum swab-based exosome DNA biopsy test that focuses on exosome DNAs (exoDNA), which enter philtrum from circulating body fluid. OncoGx16 analyzes exoDNA in the sample to identify differential DNA energetic alterations in the DNA conformation that featured cancer-specific epigenetic alterations.

What are the benefits to using OncoGx16?

OncoGx16 empowers pet owners to provide first-response care to their furry kids by ruling out the possibility of the dreadful disease, when indifferentiable signs of illness are noticed. As a multi-cancer detection test, OncoGx16 detects a wide spectrum of cancers, including the 7 most common cancers. When used for screening, OncoGx16 may help pet parents detect cancer earlier, thereby improving the outcomes. When used as an aid in diagnosis, OncoGx16 can provide useful information for tumors that may be difficult to access by fine needle aspiration, biopsy or surgery due to accessibility in the body. 

Can OncoGx16 determine the location of the cancer?

NO! OncoGx16 test is limited to qualitatively reporting the presence or absence of molecular conformational alterations associated with specific type of cancer - a “cancer DNA epigenetic signal”.  It is not able to reveal the anatomical location of the malignant tumor.

Can the test be used on cats?

NO!  OncoBark has been uniquely designed to work in dogs and is indicated for use in domestic canids only (pet dogs).  We are currently working on OncoMeow to extend this technology to cats with a separate product.

What do I do when the OncoGx16 test result is positive and the subsequent clinical evaluation does not indicate the presence of cancer?

If the clinical evaluation does not result in a cancer diagnosis for the listed 16 types of cancer, this could mean that the selected confirmatory tests did not identify the cancer, or that the OncoGx16 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.  We also encourage you to redo a OncoGx16 test to rule out inadvertent errors. 

What do I do when the OncoGx16 test result is negative and follow-up diagnostic workup suggests the presence of cancer?

OncoGx16 does not detect all the cancer each time cancer is present. As with all tests, false negative results will occur. Each case should be managed by the veterinarian taking all available clinical information into account, including details related to the patient’s clinical examination and diagnostic workup. Additional diagnostic efforts and/or treatment should not be delayed if clinically indicated, irrespective of the results from an OncoGx16 test.

Early-stage cancer may not provide sufficient detectable signal. Consider retesting again in 2 months if cancer remains high on the differential diagnosis list, as advancing disease generally provides a higher cancer signal.

Will OncoGx16 results be influenced by other clinical conditions?

Conditions other than cancer are not known to be associated with impairments in DNA repair, redox and cell cycle regulation, so are unlikely to confound the results of OncoGx16 testing.  Dogs with a wide variety of non-cancer aging conditions were included in the “cancer-free” cohort in the OncoGx16 validation study, which demonstrated a very low false positive rate of less than 0.5%.

Will sedation impact the sample?

Sedatives and/or anesthetics are not expected to impact the OncoGx16 test.

Does OncoGx16 kits expire?

The testing components in the kits do expire. However, most kits will have a shelf life for 24 months when they are shipped.

Can OncoGx16 determine the location of the cancer?

NO! OncoGx16 test is limited to qualitatively reporting the presence or absence of molecular conformational alterations associated with specific type of cancer - a “cancer DNA epigenetic signal”.  It is not able to reveal the anatomical location of the malignant tumor.

Can I get help if I need to discuss my pet’s result in more detail?

If you need help interpreting test results or have questions, please contact our Support and Success team and we will be happy to assist you further.

Our Support and Success team can be reached by phone at 978 248-8989 or via email at [email protected]