FAQs

FAQs

Answers to frequently asked questions about the Avantect Pancreatic Cancer Test are listed below. If you do not find the information you are looking for, please feel free to contact us.

  • About the Avantect test
  • Billing and Coverage
  • Test Ordering and Logistics
  • Result Interpretation

The Avantect Pancreatic Cancer Test is a new cell-free DNA-based blood test that detects epigenomic and genomic signals of cancer from cell-free DNA (cfDNA) circulating in blood. It is performed in ClearNote Health’s CLIA-certified and CAP-accredited laboratory. The test enables early detection of pancreatic cancer in patients with high risk for the disease, such as those aged 50+ who are newly diagnosed (within 36 months) with type 2 diabetes.

The test is for people at higher risk of pancreatic cancer including patients over the age of 50 who are recently diagnosed (within three years) with type 2 diabetes. Research shows that 1 out of 100 patients in this group will be diagnosed with pancreatic cancer within 3 years, this test aims to give you peace of mind.  We will also accept tests, when ordered, for patients with family history or genetic mutations for pancreatic cancer.  

We accept specimens from Medicare patients.

Physicians or other physician-designated healthcare professionals can order the Avantect Pancreatic Cancer Test.

The treating healthcare provider will determine the testing protocol that’s right for their patient.

The Avantect Pancreatic Cancer Test measures the presence or absence of an abnormal signal in cell-free DNA that is associated with pancreatic cancer.

The Avantect Pancreatic Cancer Test’s analytical performance has shown an overall sensitivity of 66.7% and a specificity of 96.9%. Sensitivity for early stage I and II pancreatic cancer was 68.3%.1
  • Precision and Accuracy: The Avantect Pancreatic Cancer Test is tailor-made for pancreatic cancer detection. With a Stage I/II sensitivity of 68.3%, it offers a heightened level of accuracy specifically for this cancer type.
  • Importance of Early Detection: Detecting pancreatic cancer early is crucial, as it significantly improves the chances of patient survival.  While multi-cancer tests provide a wider range of cancer detection, their precision in identifying specific cancers, especially at early stages, might be compromised.
  • Tumor Origin Clarity: Multi-cancer tests can occasionally face challenges in accurately determining the tissue of origin for a tumor signal, making it difficult to conclusively identify or rule out certain cancer types.1  Avantect is exclusively designed for the detection of pancreatic cancer, eliminating the need to determine the tissue of origin
Reference: 1. Loomans-Kropp HA, Umar A, Minasian LM, Pinsky PF. Multi-Cancer Early Detection Tests: Current Progress and Future Perspectives. Cancer Epidemiol Biomarkers Prev. 2022 Mar 1;31(3):512-514.
  • Higher Sensitivity and Specificity: The Avantect Pancreatic Cancer Test is designed with advanced technology that offers superior sensitivity and specificity compared to traditional biomarkers. This means Avantect can detect pancreatic cancer with greater accuracy, reducing the chances of false positives and negatives.
  • Early Detection Capabilities: Traditional biomarkers like CA 19-9 or CEA may not always be effective in detecting pancreatic cancer at its earliest stages. Avantect, on the other hand, is tailored to identify specific genetic markers that can indicate the presence of cancer even in its nascent phase, enhancing the chances of timely intervention.
  • Reduced Ambiguity: Traditional biomarkers can sometimes produce ambiguous results, making it challenging to determine the exact nature or stage of the disease. Avantect can provide clearer insights, allowing for more informed clinical decisions.
  • Sequential Diagnostic Approach: Avantect may serve as a primary early-detection tool, identifying patients with a signal associated with pancreatic cancer. When a high-risk or positive result is indicated by Avantect, imaging techniques such as EUS (Endoscopic Ultrasound) and MRI are then employed to provide detailed visual insights into the pancreas.
  • Enhanced Accuracy: By combining the molecular insights from Avantect with the visual data from EUS and MRI, clinicians can potentially achieve a more comprehensive and accurate diagnosis. This multi-modal approach ensures that potential tumors are not overlooked and that benign conditions are not mistakenly treated as malignant.
  • Cost-Effective Strategy: Starting with Avantect as a screening tool may be more cost-effective. By identifying high-risk individuals first, limited imaging resources like EUS and MRI can be better allocated to those who need them most, reducing unnecessary procedures and associated costs.

The Avantect Pancreatic Cancer Test represents cutting-edge technology and is newly available. ClearNote Health accepts all insurances and will bill payers according to their coverage policies for diagnostic testing. In the event a payer does not cover or reimburse directly for the Avantect Pancreatic Cancer Test, ClearNote Health offers a financial assistance program or a low self-pay rate to support patient access to testing.

ClearNote Health offers financial assistance for patients uninsured, underinsured, or patients electing to self-pay. Our Customer Success Team is available at +1 833-258-7827 and will help patients navigate out-of-pocket expenses where coinsurance, copays, or deductibles may occur per individual insurance plan coverage policies. In the event insurance does not offer coverage for the test, patients may access the financial assistance program and establish flexible payment plans. Out-of-pocket expenses offered through the ClearNote Health patient financial assistance or self-pay programs can range from $0 to $495, based on individual financial needs.

In addition to accepting HSAs, FSAs, and patient insurance, flexible payment plans are available.

Please reach out to our Customer Success Team at +1 833-258-7827.

ClearNote Health will bill insurance directly. Patients may also use their HSA/FSA to cover the cost of testing. For patients where a copay, deductible, or coinsurance exists, ClearNote Health will invoice patients according to their insurance coverage policy terms, financial assistance copay responsibility, payment plan, or self-pay rate.

Patients should call Customer Success at +1 833-258-7827 to share their invoice information.

  • If they have insurance, their insurance carrier will provide them with an Explanation of Benefits. This explains their level of coverage for a health care service and indicates the amount of patient responsibility. An Explanation of Benefits from their insurance company is not a bill.
  • If patients receive an invoice from ClearNote Health, this represents their patient responsibility according to their insurance carrier.
  • In the event that their insurance carrier does not offer coverage for the Avantect Pancreatic Cancer Test, ClearNote Health can work with them to determine eligibility for financial assistance or a payment plan that’s right for them.

Please contact the Customer Success Team at +1 833-258-7827.

Ordering is easy. Establishing your provider account is the first step in requesting the Avantect Pancreatic Cancer Test kit and subsequently placing an order. Just go to our website, click on the “Test Ordering” tab and simply complete the Provider Account Set-up Form. Once you click the SUBMIT button, you’ll receive a confirmation that your submission has been completed. A ClearNote Health Customer Success Representative will review the information you submitted and reach out to explain the next steps in requesting the test kit and placing a test order.

We are accepting international orders through your local distributor. If we do not have a distributor identified in your area, please let our Customer Success Representative know your preferred laboratory for diagnostic services in your area. We will reach out to them to see if we can facilitate your order.

The Avantect Pancreatic Cancer Test requires 10 mL of blood for each of the two Cell-Free DNA BCT® Streck tubes provided in the test kit.

Patients do not need to fast prior to their blood draw.

The turnaround time for the Avantect Pancreatic Cancer Test is within 14 calendar days after receiving samples at our CLIA-certified and CAP-accredited laboratory.

A ClearNote Health Customer Success Representative will send the test result report through a secure, encrypted email to the ordering healthcare provider as soon as the report is ready.

Please contact our ClearNote Health Customer Success Department at
+1 833-258-7827 to cancel the order, and the Customer Success Representative will immediately process the cancellation request.

The test report summarizes the results generated from the Avantect Pancreatic Cancer Test, which is performed in ClearNote Health’s CLIA-certified and CAP-accredited laboratory. It provides background on what the results mean for the provider and the patient, recommended follow-up based on test results, and general information about the methods used for the test.

This result means that an abnormal signal was not found. It is based on comparing your patient’s epigenomic and genomic signal with the signals of thousands of samples tested at ClearNote Health to develop the test. This does not necessarily mean that there is no cancer, as the test can generate false-negative results. Currently there are no established guidelines or professional society recommendations for repeating the test in such cases, and it is left to the treating healthcare provider to determine medical necessity for further testing. Clinical studies that determine the utility of repeat testing 6 months after a negative result are ongoing.

This result means that an abnormal signal was found. It is based on comparing your patient’s epigenomic and genomic signal with the signals of thousands of samples tested at ClearNote Health. Communication of the test result in a setting that includes appropriate counseling as well as clinical and diagnostic follow-up is recommended. An abnormal result indicates that pancreatic cancer may be present. It could also mean that there are other abnormal conditions in the pancreas, including Intraductal Papillary Mucinous Neoplasm (IPMN) and pancreatitis. It also may represent a cancer outside the pancreas. There is also a small chance of false-positive results from the test even if the pancreas has no significant abnormalities and no cancer is present.

The Avantect Pancreatic Cancer Test is a non-invasive early detection tool to help identify patients who may have pancreatic cancer. The Avantect Pancreatic Cancer Test is not intended for a definite diagnosis of pancreatic cancer, and results should be considered with other clinical criteria and communicated in a setting that includes appropriate counseling. Diagnostic imaging and biopsy are the standard of care used to definitively diagnose pancreatic cancer.

The Avantect Pancreatic Cancer Test is not intended for use as a definitive diagnostic tool for pancreatic cancer. Several diagnostic procedures (eg, ultrasound, computed tomography scan, fine-needle aspiration, angiography, endoscopic retrograde cholangiopancreatography (ERCP), and laparoscopy), are available to confirm the presence or absence of pancreatic cancer. Clinical management after a positive result is at the discretion of the healthcare provider and may involve referral to a specialist for further diagnostic evaluation.

Analysis of cfDNA does not always correlate to the presence of pancreatic cancer. False-negative and false-positive results can occur. Not all patients with pancreatic cancer will receive an “Abnormal Epigenomic Signal was DETECTED” result and some patients without pancreatic cancer will have such a result. A discrepancy between test results and diagnostic imaging results could happen for a variety of reasons, including abnormal conditions of the pancreas other than cancer, as well as pancreatic cancer that cannot be picked up by imaging alone. The treating healthcare provider should determine if follow-up or surveillance testing using the Avantect Pancreatic Cancer Test is medically necessary to guide additional or ongoing treatment decisions in newly diagnosed diabetes patients.

A QNS result stands for “Quantity Not Sufficient.” This means that the biological material used in the test was not adequate to generate a highly confident result that passes quality control measures used in the laboratory. A minimum amount of cell-free DNA (cfDNA) is required to ensure the test works as intended. Test results should be considered in the context of other clinical criteria, and further clinical management is at the discretion of the treating healthcare provider. In most cases, a blood redraw may be a suitable option. Please reach out to the Customer Success department for any further questions.

Please reach out to Customer Success at +1 833-258-7827 and we will ensure that you speak to someone at ClearNote Health who can address your questions.

The Avantect Pancreatic Cancer Test is designed to specifically detect pancreatic cancer in patients. This can include patients over the age of 50 who are newly diagnosed with type 2 diabetes. Analysis of cfDNA does not always correlate to the presence of pancreatic cancer. False-negative and false-positive results can occur. There are instances where an “Abnormal Epigenomic Signal was DETECTED” result may represent a malignancy outside the pancreas or it could mean that there are other abnormal conditions in the pancreas, including Intraductal Papillary Mucinous Neoplasm (IPMN) and pancreatitis.

Important information

The Avantect Pancreatic Cancer Test is an early detection test. The test does not establish a diagnosis of pancreatic cancer, and results should be considered in the context of other clinical criteria. Definitive diagnosis of pancreatic cancer usually requires a series of imaging scans, blood tests, and a biopsy. Not all pancreatic cancers will be detected. Some patients with pancreatic cancer may have a “Signal not detected” result. Some patients without pancreatic cancer may have a “Signal detected” result. False-negative and false-positive results are possible. A “Signal not detected” result does not guarantee that no pancreatic cancer is present. In some cases, no result is obtained. While this is very uncommon, it may be caused by shipping delays or when there is not enough cell-free DNA for the test in the patient’s blood. If this happens, we generally ask for a repeat blood sample for testing at no extra cost.

The test was developed in the ClearNote Health CLIA-certified (CLIA# 05D2249973) and CAP-accredited (CAP# 9219174) laboratory and has not been cleared or approved by the US Food and Drug Administration (FDA).

References and notes

  1. ClearNote Health, data on file.