Contact Us:949-229-0094Test@Btgenomics.com

Test Overview

Utilizing patented DNA Methylation technology, the BT-Reveal Early Pancreatic Cancer Test is able to catch faint tumor DNA signals in the blood even at extremely low concentrations.

This means the test can accurately detect early stages of pancreatic cancer (pancreatic ductal
adenocarcinoma – PDAC) when symptoms may not be present and while the cancer is still able to be treated and remedied through surgery and other techniques.

The test received FDA Breakthrough Device designation in April 2023 and is currently being offered as a Laboratory Developed Test (LDT) by BREAKTHROUGH GENOMICS through their CAP and CLIA-certified advanced clinical lab in Southern California.

– The test is non-invasive and easy-to-order
Requires only a 10ml tube of blood that can be stored and transported at room temperature
– No out-of-pocket patient costs for most patients with submission of insurance information or Medicare coverage

FDA BREAKTHROUGH DEVICE Program

FDA Breakthrough Device Program

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The FDA granted this test the status as a “BREAKTHROUGH DEVICE” because the test was able to demonstrate that it addresses an unmet medical need and was able to show that it has the potential to save lives.

The goal of the FDA’s Breakthrough Device Program is provide patients with timely access to new medical devices and diagnostic tests that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Device Program may also apply to certain devices that benefit populations impacted by health and/or healthcare disparities. Being granted ‘Breakthrough Device Status’ is intended to speed up the development, assessment, and review of these devices while preserving the statutory standards for full FDA approval.

The BT-Reveal Early Pancreatic Cancer Test is exclusively available through
BREAKTHROUGH GENOMICS. The company provides genetic tests for rare disease
diagnosis and early cancer detection at its CAP and CLIA-certified,
advanced clinical lab in Southern California.

If you have questions or would like more information please email us: test@BTGenomics.com

Technology Partner:

Additional Information

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The BT-Reveal Early Pancreatic Cancer Test is intended for use as a screening tool for at-risk individuals. A positive result does not guarantee the individual has cancer. For all positive results, additional follow-up imaging and other confirmatory tests are recommended. Common follow up testing includes CT Scans, MRI’s, Endoscopic Ultrasounds, or ERCP tests.

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Breakthrough Genomics’s clinical laboratory in Irvine, California is certified in the U.S. under the Clinical Laboratory Improvements Amendments (CLIA) and by the College of American Pathologists (CAP) to perform high complexity clinical genomic tests. The BT-Reveal Early Pancreatic Cancer Test only requires a 10ml tube of blood that can be stored and transported at room temperature. The test is currently being offered as a Laboratory Developed Test (LDT) and as such surpasses the lab’s requirements needed to be able to safely provide the test to at-risk individuals.

2 Hughes #100, Irvine, CA 92618

Breakthrough Genomics