Introduction

Cancer genetic predisposition is a genetic variation typically inherited from a patient's parent, and increases the likelihood of developing a cancer. Certain mutations can greatly increase the risk of developing cancers while others may have much smaller effects. For example, mutations in cancer predisposition genes are associated with 3% to 5% of breast and colorectal cancers, and as much as 15% of ovarian cancer.

Exome sequencing test can determine if a patient has increased risk of multiple types of cancers. This increased risk can often be managed by monitoring, preventive medication or even prophylactic surgery. Family members of an individual who carries a pathogenic cancer mutation may also consider testing to clarify their own risk.  

Determination of a familial cancer (germline) mutation in a cancer predisposition gene may guide treatment of the cancer patient.   For examples, oncologists may consider colectomy for colorectal cancer and Lynch syndrome patients, or PARP inhibitor as treatment for an ovarian cancer patient with a BRCA1/2 mutation, or elimination of  radiation in a breast cancer patient with a TP53 mutation. (see ASCO web resource below for more information)  

Baylor Genetics. This test was developed in collaboration with Baylor Genetics, the genetic laboratory associated with Baylor College of Medicine. Baylor is one of the oldest and largest genetic testing and medical institutions in the U.S., and is a leader in cancer screening and diagnosis.

Rainbow High-Risk Cancer™ Test

Three-in-One Test

This test can be used for both clinical diagnostic and multi-cancer screening purposes.

Diagnostic test.  Based on patient's family histories or symptoms, the Baylor team will perform comprehensive analysis of over 22,000 genes from patient's exome, to determine causative genetic variations associated with patient's symptoms. Clinical interpretation focuses on pathogenic- & likely-pathogenic variants, and variants of uncertain clinical significance

Screening test.  In addition, the test simultaneously screens for genetic variations in 118 genes, covering 20 types of cancers, including breast, ovarian, lung, colorectal, prostate, gastric and pancreatic cancers. 

Pharmacogenomics Test.  The OneOme RightMed test provides your drug response profile on over 340 medications, including over 40 onocology medications.

Test Descriptions

The process starts with a physician office visit at a Rainbow-authorized clinic. The clinician will order the test for the patient.  Clinical whole exome sequencing at mean 100X-150X coverage is performed at CAP-accredited or CLIA-certified laboratories.  Data will be analyzed and clinically interpreted under ACMG guidelines by Baylor Genetics, and a physician report will be issued by a Baylor Genetics board-certified medical director.

Optional report on ACMG incidental findings. Patients can choose to receive ACMG incidental findings, which include cardiomyopathy, arrythymia, and other conditions.  

Whole exome sequencing may identify genetic variants that are unrelated to the clinical condition tested (incidental findings). These “secondary” findings may be beneficial in managing additional health conditions not anticipated by the patients or their physicians. ACMG issued guidelines on reporting genetic variations on 59 genes. These genes were determined to be “medically actionable” on disease conditions that may be manageable or even preventable. 

Is This Test Right For You?

Even if you have a cancer-predisposing mutation, or such mutation exists in your family, it does not necessarily mean that you will develop cancer. According to the U.S. National Cancer Institute, if one of the following conditions applies to you, the Rainbow High-Risk Cancer test may be right for you -

• You already have cancer symptoms
• You have a personal or family history that suggests an inherited cancer risk condition
• You have several close relatives with the same type of cancer
• The presence of birth defects, such as certain benign skin growths or skeletal abnormalities, that are known to be associated with inherited cancer syndromes
• Cancer that has developed in paired organs, such as both kidneys or both breasts
• Several different types of cancer that have occurred independently in the same person
• Cancer that was diagnosed at an unusually young age
• Specific cancer type such as male breast cancer