The test is intended for individuals who are at high-risk to develop pancreatic cancer. There’s currently 40 ICD Codes that providers can choose from when ordering this test for their patients.

In general, categories of high-risk individuals include:

• – Genetic or familial risk, including those with known genetic variants or family history of cancer
• – Unexpected weight loss or prolonged abdominal pain, nausea, or
  vomiting.
• – Chronic, acute, or familial pancreatitis or other perplexing GI conditions
• – Diagnosis of new onset diabetes without complications (Type 2)
• – High levels of CA19-9
• – Presence of pancreatic neoplasms including Intraductal Papillary Mucinous Neoplasms (IPMNs) and Mucinous cystic neoplasms (MCNs)
• – Inconclusive MRI or EUS Scans of the pancreas
• – Exposure to toxic chemicals and heavy metals including benzene, asbestos, pesticides, and chlorinated hydrocarbons

– The American Gastroenterological Association currently defines an individual as high risk if they have an estimated lifetime risk to develop pancreatic cancer that is over 5%. This is nearly 4 times the risk for the general population estimated at 1.3%.

The BT-Reveal Early Pancreatic Cancer Test works by looking for certain sets of DNA Methylation Haplotypes that are linked across the genomes of tumor DNA molecules that circulate in the blood. These unique signals are specific to pancreatic cancer and may be present well before the person experiences any symptoms of the cancer.

The test is built to achieve single base resolution by using the propriety MethylTitan bi-sulfate DNA sequencing approach that maximizes the number of tumor fragments that the test is able to sample from a 10ml tube of blood. Combined with an innovative bio-informatic analysis, the test interrogates 59 DNA Methylation Haplotype regions that have been clinically-validated for pancreatic cancer early detection. These tell-tale pancreatic cancer markers can be detected across both early and late stage PDAC cancer and also across diverse sample sets.

DNA Methylation is an essential part of the field of epigenetics which examines how DNA molecules are turned on and off to regulate cellular processes in the body. At certain sites within the DNA chain, methyl groups are added to the DNA molecule (these areas are known as CpG sites) to alter the activity and gene expression of an underlying DNA segment without electing the underlying sequence. Methylation has been shown to silence genes by blocking the initiation of transcription, to stimulate transcription elongation, and to influence splicing and other DNA regulatory function.

There’s growing evidence that cancer cells in particular exhibit noticeably different patterns of DNA methylation than healthy cells. In addition, specific types of methylated chains of DNA (known as DNA haplotypes) are unique to individual cancers and are more accurate than single site DNA Methylation markers (Guo et al, Nature Genetics 2017). Utilizing DNA Methylation Haplotypes to detect for early cancer is a patented technology that has been demonstrated to have a high predictive value for a number of different cancers including colon, breast, renal, and pancreatic cancer (Chen et al, Nature Communications, 2020).