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Home2021March
Press Release

Bluestar Genomics Receives FDA Breakthrough Device Designation for First-of-Its-Kind Pancreatic Cancer Screening Test

ClearNote Health
March 31, 2021

ClearNote Health Announces Leadership Transition

ClearNote Health
July 9, 2026

Meet Us at ASCO 2026

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May 28, 2026

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Important information: 
The Virtuoso platform is for research use only. Not for use in diagnostic procedures.

The Avantect Pancreatic and Ovarian Cancer Tests are early detection tests. The tests do not establish a diagnosis of pancreatic or ovarian cancer, and results should be considered in the context of other clinical criteria. Definitive diagnosis of pancreatic or ovarian cancer usually requires a series of imaging scans, blood tests, and a biopsy. Not all pancreatic or ovarian cancers will be detected. Some patients with pancreatic or ovarian cancer may have a “Pancreatic/Ovarian Cancer Signal not detected” result. Some patients without pancreatic or ovarian cancer may have a “Pancreatic/Ovarian Cancer Signal detected” result. False-negative and false-positive results are possible. A “Signal not detected” result does not guarantee that no pancreatic or ovarian 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 tests were developed in the ClearNote Health CLIA-certified (CLIA# 05D2249973) and CAP-accredited (CAP# 9219174) laboratory and have not been cleared or approved by the US Food and Drug Administration (FDA).

Cancer statistics quoted on this website are taken from the CDC and SEER websites, 2025 data.

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Avantect and Virtuoso are trademarks of ClearNote Health. Other trademarks are the property of their respective owners.

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