The test requires one 10ml tube of blood collected in a standard Streck test tube.  Breakthrough Genomics provides these tubes to healthcare providers. Each streak tube contains a special preservative to limit cell lysis and to minimize the degradation of circulating tumor cells during storage and transportation.

No fasting or other preparation is not required for patients prior to the blood draw.

Some providers are able to do the blood draw directly in their office. If this is not the case, then once the test is ordered by the provider through the online portal, the patient will be contacted by our team and given options for scheduling their blood draw. We currently have arrangements with 2 companies Travalab and Any Lab Test Now that can help you with the blood draw. Travalab sends a mobile nurse (called a phlebotomist) to the patient’s home to collect the sample and Any Lab Test Now has over 220 retail locations across 31 states where the patient can get the sample taken.

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.

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.  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 or faxed to Breakthrough Genomics prior to sending the sample.  When scheduling a blood draw with Travalab, the collection kit will be sent to the patient’s home prior to the scheduled appointment date for use when the mobile nurse arrives.  After the sample is collected, the mobile nurse handles the sample and shipping.

The standard turnaround time is between 4 to 6 weeks.

The provider will be notified via email when the test results are ready to be retrieved from the secure online portal. Once the results are in, it is up to the provider to notify the patient about the test results. Test results are only shared with the healthcare provider who placed the order and never directly to patients or their families.

No, the test and blood draw can only be scheduled through participating Health Care Providers or through Any Lab Test Now.  Additionally, patients can schedule their blood draw for the test with the the mobile blood sample collection service called Travalab.

Yes, secure online delivery of test results through our online portal is preferred, but fax delivery of test results is available upon request by providers. Test requisition forms can also be faxed to our lab.  Test results are only shared with the healthcare provider and never directly to patients or their families.

In a very few cases, a patient may be asked to redraw the blood sample because and insufficient amount of cell-free DNA was able to be extracted from the initial sample. It’s important to note that the failure of a given blood sample to meet the lab’s quality control standards has nothing to do with wether a sample is more or less likely to test positive or negative for the presence of pancreatic cancer.

Breakthrough Genomics is working diligently with leading insurance providers as well as the U.S. government’s Medicare program to remove as many financial barriers as possible and ensure that individuals that need this test can benefit from this breakthrough technology without undue financial burden.
As a result, there will be no out-of-pocket costs for PPO patients who qualify for coverage for this test and meet the necessary criteria of being at high risk to develop pancreatic cancer and who have met their deductible. For all patients, we recommend having Breakthrough Genomics check on the specifics of your coverage before submitting your blood sample for the test as there are many factors that can determine the ammount that a patient will have to pay for this test.
For qualified PPO and HMO patients who are covered by their plans and have not yet met their deductible or whose plans offer only partial coverage, the maximum out-of-pocket cost will be $700. In many cases, the out-of-costs will be less than $700 but we can only be certain after we check on an individual’s specific insurance coverage and deductible status.
For HMO patients, we will need to get pre-authorization from the patient’s insurer to confirm coverage before we move forward to process the sample. As with PPO insurance, the maximum out-of-pocket expenses that the HMO patient would incur would be $700.
For Medicare patients who do not have supplemental private insurance plans, the cost of the test will be $700. This price applies to any high-risk patient who is not covered through their insurance plan or who would prefer to pay for the test upfront and without involving Medicare or their supplemental insurance plans.

Please note that the Center for Medicare and Medicaid (CMS) has granted the BT-Reveal test a specific CPT billing code for this test and a fee schedule of $1770. However, we are still awaiting approval for Local Coverage Determination for Medicare from the State of California where our clinical lab is based and until that review is complete, we don’t recommend at this time pursuing Medicare coverage for this test. If Medicare denies coverage for a patient, Breakthrough Genomics will need to charge that patient according to the Medicare Fee Schedule, which for this test is $1770.

For qualified PPO and HMO patients who are covered by their plans and have not yet met their deductible or whose plans offer only partial coverage, the maximum out-of-pocket cost will be $700. In many cases, the out-of-costs will be less than $700 but we can only be certain after we check on an individual’s specific insurance coverage and deductible status.

Bills for out-of-pocket patient expenses are sent directly to the patient’s address provided in the Test Requisition Form. Healthcare providers do not need to provide additional support for the billing of out-of-pocket expenses.

Out-of-pocket expenses will be sent to the patient’s home address and can be paid through check, debit cards, credit cards, Zelle, or Venmo. Patients may also be able to pay for the out-of-pocket costs using their HSA (Health Savings Account) or FSA accounts (Flexible Savings Account).
In addition, Breakthrough Genomics also offers a convenient “Pay Later” option to pay for the cost of the test in installments. For further information on the Pay Later option or for questions regarding your FSA or HSA account please check with the administrator of the the account or email us at test@BTGenomics.com

For patients who do not have supplementary private insurance or who are not covered for the test and would prefer to pay for the test directly, the cost of the test is $700. See above for payment options.

The test is intended for individuals who have an elevated risk to develop pancreatic cancer. There are 3 main categories of high risk patients that should consider using the test.
A. People with known genetic risk factors such the genetic mutation BRCA2, Lynch Syndrome, and others, and people with a family history of cancer, including pancreatic cancer, breast cancer, ovari-an cancer, prostate cancer, or malignant melanoma. Also included in this category are adults over 50 with new onset diabetes (Diabetes milletus) which have been shown to be at significantly higher risk for pancreatic cancer than the general population.
B. People with known pancreatic cysts (confirmed through imaging) that require surveillance. Pancre-atic cysts are grouped into 3 categories (PanNETs, IPMNs, and MCNs) and all can become potential-ly malignant. In their most recent clinical practice update, the American Gastroenterology Associa-tion (AGA) highlighted the need of complementary approaches including the use of biomarkers to improve upon current modalities such as MRIs and EUS to monitor the status of known pancreatic cysts.
C. People with chronic or hereditary pancreatitis and other non-specific GI conditions including unex-pected weight loss, jaundice, unexplained back or stomach pain, and high levels of the protein CA19-9.

TThe test is meant to be used for the periodic screening of high risk individuals. Until more specific recommendations are given by professional organizations, the test is generally recommended as a yearly screening test.
The American Gastroenterology Association (AGA), the National Comprehensive Cancer Network, and other professional organizations recommend annual screening of individuals with a high risk to develop pancreatic cancer with shortened intervals for specific genetic risk factors such as Peutz Jeghers Syn-drome and hereditary pancreatitis.
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.” The current professional recommendations are specific to surveillance using imaging and don’t yet di-rectly address the use of blood-based tests such as BT-Reveal that detect specific biomarkers for pancre-atic cancer.
For pancreatic cyst surveillance there are many factors that go into determining the interval for screen-ing, including type of cyst, morphology, location, and rate of growth. Current recommendations call for yearly surveillance or for alternating between MRI or EUS every six months for monitoring To help with accurate diagnosis and to reduce unintended side effects from MRIs and EUS procedures, the AGA in their most recent clinical practice update, did highlight the need for complementary and non-invasive approaches, including the use of biomarkers, to aid in pancreatic cyst surveillance.

Because the test is new it is not yet included in professional guidelines for the periodic screening of high risk individuals. However, the granting of Breakthrough Device Status for this test by the FDA and comments in recent professional publications suggest that guidance on blood-based screening tests for pancreatic cancer will be forthcoming.

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

Patients who receive a positive test results where a cancer signal is detected should be referred to a GI specialist with experience in diagnosing pancreatic cancer. Common procedures for confirming the di-agnosis of pancreatic cancer include MRI, EUS, and ERCP.
Because pancreatic cancer is complex and differs in each individual, patients who are suspected to have pancreatic cancer should seek guidance from an experienced multidisciplinary team. Furthermore, the AGA 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.”

If a patient receives a negative result and no cancer signal was detected, then the patient should sched-ule a subsequent test for the following year. Individuals with heightened risk or known and specific genetic risk factors should be tested again in intervals shorter than one year.
A negative test result does not rule out the presence of cancer.

Pancreatic cancer can develop quickly and can often go unnoticed for many months with initial symptoms that can be hard to distinguish from other GI conditions.

The test interrogates 59 DNA methylation regions or (also known as Haplotype blocks) that have all been clinically-validated as biomarkers for detecting pancreatic cancer. The patented technology used in the test is able to investigate these blocks on a per base level to determine whether the specific signatures of pancreatic cancer are present in the individual’s blood sample.

The underlying technology for this test was initially developed at University of California San Diego in their bio-engineering department and has been licensed for this test. An important scientific paper was published in 2017 that highlights the use of DNA Methylation Haplotype Blocks as a methodology that is far more precise than traditional methods that utilize DNA methylation as biomarkers for early cancer detection.
The underlying technology and the specific bioinformatic methodology that was developed for the analysis of the test has been further refined by our technology partner Singlera Genomics.

DNA methylation is an essential part of the field of epigenetics which examines how DNA molecules are turned off and on to regulate normal cellular processes. At certain sites within the DNA chain (called cPG sites), methyl groups are added to the DNA to alter the activity and gene expression of an underlying DNA segment without altering the underlying sequence of base pairs. For example, meth-ylation has been shown to ‘silence’ genes by blocking the initiation of transcription and to influence splicing and other DNA regulatory functions.
A number of studies have shown that cancer cells exhibit noticeably different patterns of DNA methyl-ation than healthy cells. In addition, specific types of methylated chains of DNA (known as DNA Methylation Haplotypes) are unique to certain types of cancers and are more accurate than single site methylation markers. This technique was published in a 2017 seminal paper in Nature Genetics that originated out of the lab at the Department of Bioengineering at the University of California San Diego (Guo et al, Nature Genetics 2017). The same team that helped to develop the BT-Reveal test also pub-lished a subsequent paper in 2020 Nature Communications that demonstrated how DNA Methylation Haplotype blocks were shown to have high predictive value for a number of different cancers, including pancreatic cancer. (Chen et al, Nature Communications, 2020).

A few of the other tests on the market that are using DNA Methylation techniques rely on standard ‘off-the-shelf’ chemistry that can prematurely eliminate many of molecules in cell-free DNA that may contain the cancer signal, which in cell-free DNA can be extremely rare. These other approaches also tend to use very broad sequencing and enrichment approaches that are unable to achieve the deep per base resolution needed to interrogate the 59 DNA methylation blocks that characterize this test.