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Whole exome seq test


Cover 22,000 Genes

End Diagnostic Odyssey

 

Whole exome seq test


Cover 22,000 Genes

End Diagnostic Odyssey

 

Products


Increases Diagnostic Yield

The ability to analyze over 22,000 genes eliminates the limitations of the interpreting only a few or even hundreds of genes using many conventional genetic tests.  

Many patients, especially those in pediatric care, have gone through multiple genetic and biochemical testing without a positive diagnosis. It has been widely demonstrated that exome sequencing, by analyzing over 22,000 genes simultaneously, can produce relatively-high diagnostic yield that ends diagnostic odyssey. A positive diagnosis can immediately help physicians to implement treatment and monitoring programs.

Reference

Outcome of Whole Exome Sequencing for Diagnostic Odyssey Cases of an Individualized Medicine Clinic: The Mayo Clinic Experience. Mayo Clin Proc. 2016, 91(3):297-307.


Fully-Integrated Testing

Our genetic tests are based on clinical exome sequencing technology. This next-generation sequencing process is performed at CAP-accredited or CLIA-certified laboratories. To assure highly accurate test results, clinical interpretation is performed by the University of California, Los Angeles (UCLA) Clinical Genomics Center, and Baylor Genetics, both are among the largest and oldest genetic testing laboratories in the US.

In addition, some of the test results will also be analyzed by genome medicine specialists at the Juntendo University in Japan, to assure accurate diagnosis based on the most-up-to-date understanding of Asian genetics.

Pharmacogenomics tests are performed by OneOme, a company established by Invenshure and Mayo Clinic.


ACMG Incidental Findings

Included with our exome sequencing test is the reporting of ACMG incidental findings, which include breast cancer, Lynch syndrome (colon cancer), cardiomyopathy, arrhythmia and other conditions. These are findings supported by pathogenic or likely pathogenic variants (based on ACMG interpretation guideline) from 59 genes, that may or may not be related to the patient’s primary conditions. Adult patients can choose to receive these findings, or “opt out” of learning about these findings.

References

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Pediatric Care Image 1


Pediatric Care

 

Pediatric Care Image 1


Pediatric Care

 

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Pediatric Care


Rainbow Pediatric Care Test

Pediatric Care


Rainbow Pediatric Care Test

Introduction

Over 5,000 human diseases can be classified as monogenic and Mendelian disorders, and these conditions affect millions of people worldwide. Mendelian disorders also significantly contribute to morbidity and mortality of hospital-based pediatric cases. In fact, childhood Mendelian disorders account for approximately half of blindness, deafness, severe mental retardation cases, and 40-50% of childhood deaths.  

Clinical tests based on whole exome sequencing have been demonstrated to be effective in identifying genetic causes of monogenic and Mendelian diseases. This complex diagnostic process allows the examination of approximately 22,000 genes in the human exome, to improve the yield of diagnosis.

The Rainbow Pediatric Care™ test is designed for pediatric patients. These are whole exome sequencing tests, targeting a patient with clinical findings that suggest an underlying genetic etiology.


Rainbow Pediatric Care™ Test

Clinical exome sequencing is particularly useful for children with Mendelian disorders. This includes cases without a prior genetic syndrome from any family members. Often, these young patients went through multiple genetic and biochemical testing without obtaining a diagnosis, thus delaying the treatment of their conditions.

UCLA Clinical Genomics Center.  The Rainbow Pediatric Care test combines exome sequencing at 100-150 fold sequencing depth, with UCLA Clinical Genomics Center’s multiple years of experience in clinical interpretations to enhance the yield of a positive diagnosis. Suitable conditions include various developmental delays, neurological disorders, epilepsy, autism, hypotonia, childhood-onset ataxia, and dysmorphic features, etc.

Proband vs. Trio sequencing in pediatric cases.  In pediatric cases, it has been shown that sequencing both parents in addition to sequencing the child (a trio) increases the yield of a diagnosis, particularly for cases where there were no prior family histories. One reason for the higher diagnostic rate is because of the successful identification of de novo and compound heterozygous mutations via trio sequencing. Rainbow Genomics recommends trio sequencing whenever possible.


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- (College of American Pathologists) accredited or CLIA- (Clinical Laboratory Improvement Amendments) certified laboratories. 

Accurate diagnosis with clinical interpretation provided by the world’s leading experts. Data analysis and clinical interpretation of the entire exome, which consists of over 22,000 genes, is a complex process. Proven expertise is needed to assure we do not miss a causative mutation (false negative) or confirm a mutation when the patient actually does not have such a genetic change (false positive).

To assure the highest accuracy in our test results, Rainbow Genomics has contracted with the University of California, Los Angeles (UCLA) Clinical Genomics Center, one of the largest and the oldest genetic testing laboratories in the United States, to perform clinical interpretation. The entire analysis and interpretation is performed by the UCLA Clinical Genomics Center following ACMG (American College of Medical Genetics and Genomics) guidelines.

Double Clinical Interpretation for Asians.  To provide highest quality interpretation for Asian patients, some of the test results with unusual Asian genetic variations may also be analyzed by genome medicine specialists at Juntendo University in Japan.  

The medical teams at the UCLA Clinical Genomics Center and the Juntendo University have many years of experience providing genetic testing to Asian patients. More importantly, our Japanese bioinformaticians and clinicians are trained to provide clinical interpretation specifically for Asian patients including Chinese and Japanese individuals.


Is This Test Right For You?

If you or your family members already have symptoms of Mendelian or monogenic disorders, medical experts recommend genetic testing for you.

These tests may be suitable for patients who have had evaluations consisting of microarray-based, single-gene or panel-based genetic tests without identifying an etiology or obtaining a diagnosis.

Physicians may prefer to order clinical exome sequencing early in the patient's evaluation to expedite a possible diagnosis, without going through time-consuming biochemical, microarray-based, single-gene or panel-based genetic testing.

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Hereditary cancer Image


Cancers

 

Hereditary cancer Image


Cancers

 

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High risk cancer test


Rainbow High-Risk Cancer Test

High risk cancer test


Rainbow High-Risk Cancer Test

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.


Cancers Screened

1. Breast   2. Ovarian   3. Colorectal   4. Lung  

5. Prostate   6. Uterine   7. Gastric  

8. Pancreatic   9. Thyroid    10. Melanoma  

11. Renal   12. Urinary Track          

13. Central & Peripheral Nervous System Cancers  

14. Paraganglioma   15. Pheochromocytoma  

16. Brain   17. Sarcoma  

18. Neuroendocrine   19. Leukemia

20. Myelodysplastic Syndrome


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. 


OneOme RightMed Test Included

"Understand your drug response to over 340 medications"

"Including over 40 oncology drugs"

During the office visit, your physician will also collect your DNA sample through a simple cheek swab for the OneOme RightMed® pharmacogenomic test. The sample will be sent to OneOme's CAP-accredited and CLIA-certified clinical testing laboratory. The OneOme clinical team will perform the testing, analysis and issue a clinical test report.


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
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Adult genetic image


Adult Genetics

 

Adult genetic image


Adult Genetics

 

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MMC


Rainbow MMC (Mendelian and Monogenic Conditions) Test

MMC


Rainbow MMC (Mendelian and Monogenic Conditions) Test

Introduction

Early Diagnosis, Treatment and Prevention are Important for Management of Mendelian Disorders and Monogenic Diseases

Over 5,000 human diseases can be classified as monogenic and Mendelian disorders, and these conditions affect millions of people worldwide. Clinical tests based on whole exome sequencing have been demonstrated to be effective in identifying genetic causes of monogenic and Mendelian diseases.  The Rainbow MMC™ (Mendelian & Monogenic Conditions) tests is an exome sequencing test designed for adult patients.


Rainbow MMC™ (Mendelian & Monogenic Conditions) Test

Adults with Mendelian disorders or monogenic diseases could benefit from clinical exome sequencing. The test may provide a definitive diagnosis after multiple microarray or panel-based gene testing and biochemical clinical analysis that failed to produce a positive result.

Our physicians will determine the disease condition (phenotypes), and our analysis will focus on determining a causative genetic variant associated with the reported condition. Patients with the following conditions may benefit from this test – epilepsy, cancer predisposition, neurological and retinal disorders, cardiomyopathy, arrhythmia and a wide range of Mendelian disorders.  


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. Clinical interpretation is performed by the University of California, Los Angeles (UCLA) Clinical Genomics Center under ACMG guidelines.

Double Clinical Interpretation for Asians.  To provide highest quality interpretation for Asian patients, some of the test results with unusual Asian genetic variations may also be analyzed by genome medicine specialists at Juntendo University in Japan.  

The medical teams at the UCLA Clinical Genomics Center and the Juntendo University have many years of experience providing genetic testing to Asian patients. More importantly, our Japanese bioinformaticians and clinicians are trained to provide clinical interpretation specifically for Asian patients including Chinese and Japanese individuals.

Optional ACMG incidental findings. 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. These conditions include inherited colon and breast cancers, inherited cardiac diseases such as cardiomyopathy and arrhythmia, familial hypercholesterolemia, and malignant hyperthermia susceptibility, etc. Rainbow Genomics provides adult patients the option to obtain, or “opt out” of receiving these findings.


OneOme RightMed Test Included

"Understand your drug response to over 340 medications"

"Including over 40 oncology & 30 cardiovascular drugs"


During the office visit, your physician will also collect your DNA sample through a simple cheek swab for the OneOme RightMed® pharmacogenomic test. The sample will be sent to OneOme's CAP-accredited and CLIA-certified clinical testing laboratory. The OneOme clinical team will perform the testing, analysis and issue a clinical test report.


Is This Test Right For You?

If you or your family member already have symptoms of Mendelian or monogenic disorders, medical experts recommend genetic testing for you.

These tests may be suitable for patients who have had evaluations using microarray-based, single-gene or panel-based genetic tests without identifying an etiology or obtaining a diagnosis.

Physicians may prefer to order clinical exome sequencing early in the patient's evaluation to expedite a possible diagnosis, without going through time-consuming biochemical, single-gene or pane-based genetic testing.


Physician Order Required


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Cardio

 

 

 

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Cardio

 

 

 

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Cardio Test


Rainbow Cardio Test

Cardio Test


Rainbow Cardio Test

Introduction

According to American Heart Association 2015 statistics, about one-third of adults will develop a heart condition. Specifically, cardiovascular disease is the leading cause of death among Asians (including ethnic Chinese & Japanese) in Hong Kong and Japan.

Clinically-validated genetic testing leading to a confirmed diagnosis is a powerful tool to manage hereditary cardiovascular disease risks. Health management plans including treatment, remote-monitoring and prevention strategies may be implemented following a diagnosis.

In addition, genetic risks are independent of other clinical factors such as LDL, BMI, blood pressure, etc., and are complementary to traditional clinical factors, allowing physicians to improve the accuracy of life-time risk calculations.


Rainbow Cardio™ Test

Comprehensive testing of most hereditary cardiovascular disease conditions in one test. The Rainbow Cardio™ test is a whole exome sequencing test covering 22,000 genes.  We specifically analyzes over 200 genes, representing 23 hereditary cardiovascular diseases and RASopathy conditions. Our results cover most diseases typically tested by physicians to determine cardiovascular genetic risks, including:

  • Familial Hypercholesterolemia (FH)
  • Hypertrophic cardiomyopathy (HCM)
  • Dilated cardiomyopathy (DCM)
  • Sudden Cardiac Arrest (SCA)
  • Long QT syndrome (LQTS) & Short QT syndrome (SQTS)
  • Pulmonary Arterial Hypertension
  • Catecholaminergic polymorphic ventricular tachycardia (CPVT)
  • Arrhythmogenic right ventricular cardiomyopathy (ARVC)
  • Common genetic risks of myocardial infarction (MI) and atrial fibrillation (AF)


Test Descriptions

Rainbow Cardio™ clinical exome sequencing services provide comprehensive testing of 23 cardiovascular disease, muscular dystrophy and RASopathy conditions.  

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. Clinical interpretation is performed by the University of California, Los Angeles (UCLA) Clinical Genomics Center under ACMG guidelines. Some of the test results with unusual Asian genetic variations may also be analyzed by genome medicine specialists at the Saitama Medical or Juntendo University in Japan.

Sanger Sequencing.  An additional Sanger sequencing test will be preformed to determine population-based, common-genetic risks for myocardial infarction and atrial fibrillation, based on 4 SNPs. Interpretation is provided by the genome medicine team at Rainbow Genomics. Population-based genetic risks are independent of family history and clinical factors such as BMI, age, LDL level, etc., providing additional evidence to guide physicians developing prevention strategies.

Optional report on ACMG incidental findings. Patients can choose to receive ACMG incidental findings, which include breast cancer, Lynch syndrome (colon cancer), and other conditions.


OneOme RightMed Test Included

"Understand your drug response to over 340 medications"

"Including over 30 cardiovascular drugs"


During the office visit, your physician will also collect your DNA sample through a simple cheek swab for the OneOme RightMed® pharmacogenomic test. The sample will be sent to OneOme's CAP-accredited and CLIA-certified clinical testing laboratory. The OneOme clinical team will perform the testing, analysis and issue a clinical test report.


Is This Test Right For You?

If you or your family member already have symptoms of hereditary cardiovascular diseases, medical experts recommend genetic testing for you. A positive diagnosis could inform your doctor to consider changing your medical care, including monitoring or more aggressive care management by a cardiologist.

With a positive diagnosis, there is a significant chance that your children, brothers and sisters may also have the same genetic variations. Your family members may consider to be tested to confirm their own genetic risks. Any family members who also carry these genetic variants are considered to have elevated risks, and should be examined by a physician or cardiologist.





Physician Order Required