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Frequently Asked Questions (FAQs)

Have questions? Here you’ll find the answers most valued by our partners, along with access to step-by-step instructions and support.

Questions about Logistics:

1. What type of blood sample does the test require?

The BT-Reveal Early Pancreatic Cancer Test requires a standard Streck test tube of 10ml of blood.  Breakthrough Genomics provides these tubes to healthcare providers. Each tube provided contains a special preservative to limit cell lysis and to minimize the degradation of circulating tumor cells during storage and transportation.

2. Is fasting required prior to the blood draw?

No, no fasting is not required for patients prior to the blood draw.

3. How does the shipping work? Does it get picked up or does it get mailed?

A prepaid envelope will be provided to the healthcare provider to be used to ship the sample to the Breakthrough Genomics lab.  The sample does not need to be ‘spun down’ before shipping.

4. What information should be included on the label of the test tube?

The label on the test should contain the patient name, date of collection, and date of birth.  A test requisition form needs to be filled out in the online portal prior to sending the sample.

5. How long can the blood sample last without starting to degrade?

Once in the tube, the blood sample is effective for up to seven days at room temperature (15-30° celsius) and can be stored and transported without refrigeration.

6. Can we order the blood draw from a different lab (For example: LabCorp) and have it sent by them to Breakthrough Genomics?

Currently it is not possible to order the blood draw from either LabCorp or Quest. The doctor or medical office who helped you order the test will provide detailed information on when and where to get the blood draw. This will depend on which state you live in and whether your healthcare provider is able to collect the blood sample at their office or partner facility. In come cases, it is possible to have a mobile phlebotomy service collect the blood sample at a patient’s home. For all questions regarding collecting and transporting blood samples, please email us at Test@BTGenomics.com

7. Is it possible for doctors to get the results delivered via FAX instead of electronically?

Yes, secure online delivery of test results through our online portal is preferred, but fax delivery of test results is available upon request. Test results are only shared with the healthcare provider and never directly to patients or their families.

8. Is the test covered by Medicare or private insurers?

We are happy to announce that this test is now being covered by Medicare and most Private Insurers. That means that for a limited time, patients who need the test and who qualify will not be required to pay any out-of-pocket costs.

Questions About the Test and it’s Use :

1. Who originally developed the technology?

The underlying technology for this test was initially developed by a bio-engineering Professor at UC San Diego named Dr. Kung Zhang.  His pioneering work with using DNA Methylation Signals as an early marker for cancer began in 2009 and is ongoing.  Dr. Zhang is credited as a principal investigator and co-author on 45 scientific publications and is known for his groundbreaking work using NGS technologies to screen for cancer and other previously “unsee-able” medical conditions.

2. How does the test perform so well for early stage detection?

Scientists say that finding very faint signals circulating in someone’s blood is like finding a needle in a giant haystack.  We prefer the analogy of fishing for rare fish in a fast moving stream. To be successful, and to catch as many hard-to-find-fish as possible, the test needs to have the right bait, it needs to look in the right places, and it needs a way to bring the fish to the surface.
The patented bi-sulfate MethylTitan technology utilized in the test is the right bait – it efficiently detects methylation blocks in cell-free DNA circulating in the blood that are specific to pancreatic cancer.  This enables the test to yield in-depth sequencing resolution of DNA Methylation on a per-base level that is unlike any other technology in the space.  The special wet-lab chemistry that is used is indeed the “special bait” that can seen by just the right kind of fish that test is looking to attract.
Next, by investigating 59 distinct and clinically-validated genomic regions (DNA Haplotypes) in each sample, the test is placing this ‘bait’ in the right places where these unusual DNA patterns (the fish) can be found.  When these DNA blocks become activated or de-activated in these specific locations, the test confirms it has found the tell-tale signs of pancreatic cancer in someone’s blood sample.
Finally, to bring these cancer signals (or fish in the analogy) to the surface and to return a positive or negative test result, the test leverages an advanced AI-based computer analysis that accurately determines whether a cancer signal has been sufficiently detected.

3. Does the test return a specific score along with the results or are are test results binary?

No score or numerical scale is returned along with test results. Test results are binary and report whether a cancer signal was detected or not.

4. What is the recommended interval for patient screening?

While there is currently no standard surveillance protocol for individuals who are at high risk to develop pancreatic cancer, the American Gastroenterologist Association has published a list of “Best Practices” on their website (link below).  Among their recommendations, is the need to begin surveillance for most at-risk categories starting at age 50 and a baseline screening interval of 12 months.  The paper also states that “new-onset diabetes in a high-risk individual should lead to additional diagnostic studies or change in surveillance interval.”  Here’s the link for more information from the AGA
https://www.gastrojournal.org/article/S0016-5085(20)30657-0/fulltext.
The specific interval for use of this screening test should always be considered on per patient basis by the healthcare provider, with shortened intervals recommended for individuals deemed to be at extremely high-risk or for patients who exhibit other potential signs of the presence of pancreatic cancer.

5. What happens if a patient gets a positive result and a negative follow-up scan?

Positive Tests Results should be followed up with an Endoscopic Ultrasonagraphy (EUS) or a MRI scan by a multidisciplinary team.  Performing an additional BT-Reveal follow-up test with a new blood draw is another option that healthcare providers and their patients should consider.  Because pancreatic cancer is complex and differs in each individual, patients who are suspected to have pancreatic cancer should seek guidance from an experience multidisciplinary team.

The American Gastroenterology Association states that “Decisions regarding therapy directed towards abnormal findings detected during screening should be made by a dedicated multidisciplinary team together with the high-risk individual and their family.”

6. What is the correlation between diabetes and pancreatic cancer risk?

Many published studies have shown that diabetes (both type 1 and type 2) can be a risk factor for pancreatic cancer.  Research has also shown a strong association between pancreatic cancer and recently diagnosed diabetes (late onset, type 2).

A meta-analysis study in the journal Nature also reported that the development of diabetes in older adults “may be an early manifestation of the tumour” and that pancreatic cancer may even “induce a diabetic state.”  Click here to read that paper (https://rdcu.be/dl4LA )

Additionally, a 2018 study published in Gastroenterology presented strong evidence that a individual’s blood sugar can rise as early as 3 years before a diagnosis of pancreatic cancer. (https://pubmed.ncbi.nlm.nih.gov/29723506/)

For links to additional studies and information highlighting the link between diabetes and pancreatic cancer please email test@btgenomics.com

7. Who do I ask if I have questions about the Test?

If you have questions about the test or your results, please contact your doctor or the medical office that helped order your test. If you are a healthcare provider and have questions, please email us at test@BTGenomics.com

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Breakthrough Genomics