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Predictive Screening

&

Pharmacogenomics

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Predictive Screening

&

Pharmacogenomics


Genetic Screening for Healthy Individuals

Predictive and presymptomatic testing.  These tests are used to determine genetic variations associated with hereditary disorders including familial cancers, heart diseases, neurological disorders and many rare Mendelian and monogenic disease conditions. Healthy individuals, especially those who have one or more family members already diagnosed with a genetic disorder, may benefit from these tests. A positive result may help the individuals and their physicians to develop more effective prevention and early-detection strategies. 


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Adult Screening Image


Your Health, Reproductive Health,

Drug Response to 340+ Medications

Adult Screening Image


Your Health, Reproductive Health,

Drug Response to 340+ Medications

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Adult Screening


Rainbow Adult Screening Exome Sequencing Test

Adult Screening


Rainbow Adult Screening Exome Sequencing Test

Introduction

Over 5000 genetic disorders are known, and many more, including over 6000 conditions are reported within various clinical and bioinformatics databases.  With clinical whole exome sequencing covering over 22,000 genes, we comprehensively screen for pathogenic mutations associated with these disorders.  

Unlike many "recreational" or "direct-to-consumer" genetic tests that report hundreds of findings with questionable or no clinical utilities, our whole exome sequencing approach reports pathogenic (and likely-pathogenic) mutations that are supported by clear medical evidence and are clinically-actionable.  That is, your physician can develop screening and prevention strategy to manage the disease risk.  Plus, our genetic counselors will provide consultation to help you understand the health and psychological implications.


Rainbow Adult Screening Exome Sequencing Test

The Rainbow Adult Screening Exome Sequencing Test provides clinically- actionable results:

  • Your Health - Your risk of developing genetic disorders in the future.
  • Your Reproductive Health - Your risk of passing on genetic disorders to your children.
  • Your Drug Response to over 340 medications
  • Heart Attack and Ischemic Stroke Risk 
  • Your personal, one-hour, bilingual genetic counseling session included!

By delivering clinically- actionable results, we enable your physicians to provide prevention strategies and personalized care for you.


Test Descriptions


Your Health

 
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This test screens over 22,000 genes from the entire exome, to determine your risk of developing a genetic disorder, which includes cancers, heart diseases, certain neurological disorders and numerous Mendelian and monogenic diseases.

Over 5,000 genetic disorders are known. Most of them are rare disorders. However, certain heart diseases and cancers have well-understood genetic associations. For example, about 5% of breast and colon cancers are known to be caused by genetics. Also, 1 out of 500 individuals carry mutations associated with cardiomyopathy.

This test determines the pathogenic and likely-pathogenic variants associated with genetic disorders. These are variants that have been reported in the scientific literature and are expected to increase the risk of developing a disorder.

Carrying a pathogenic mutation does not necessarily indicate that you will develop the disorder. The positive result can enable your physician to develop appropriate prevention strategy to mange your risk.  


Your Reproductive Health

This test, similar to carrier testing, screens over 22,000 genes to determined pathogenic mutations associated with recessive disorders that can be passed on to your children.

Carrier screening determines if you may carry a genetic mutation that could cause a serious inherited disorder in your baby. Over 1,300 carrier status conditions are known. Many of these conditions are rare. And many of these conditions will not be detected by routine prenatal tests.

Because these disorders are recessive, a baby must inherit a genetic variant from each parent to have the disease. If both parents are carriers, their child will have a 1 in 4 chance to be born with the disease.

Unlike many gene-panel test (includes 1-200 genes) developed by U.S. and European companies based on research using Caucasian patients, which may not include sufficient Asian genes, the Adult Screening Exome Sequencing test examines over 22,000 genes from the exome. We substantially reduces the risk of not testing genes that are specifically associated with Asian patients.

Note that this test cannot determine the carrier status of Fragile X, Spinal Muscular Atrophy (SMN) and Thalassaemias (HBA). 


Your Drug Response to over 340 Medications

Rainbow Genomics works closely with OneOme (Minneapolis, MN, U.S,) to provide comprehensive, clinically- actionable pharmacogenomic test to patients and physicians - The OneOme RightMed pharmacogenomic test.

Co-developed and exclusively licensed with Mayo Clinic (Rochester, MN, U.S.), OneOme provides a comprehensive solution that determines how patients' genes may affect their response to over 340 medications.  OneOme analyzes a patient’s genetic information and provides a validated clinical report to the physician and patient.

Imprecise medication can cause delay of effective treatment, re-hospitalization, adverse events, and increased mortality. Recent U.S. studies have shown that response rates for many drugs are only between 50-75%. Also, adverse drug reactions are the 4th leading cause of death annually in the U.S. The test aims to reduce adverse drug reactions, increase drug effectiveness and prevent unintended interactions between drugs.

  • Comprehensive. Includes 22 genes, 340+ common medications, and 28 medical conditions
  • Credible. Uses clinical evidence curated with Mayo Clinic from FDA label information, Clinical Pharmacogenetics Implementation Consortium, and other professional guidelines and scientific studies

Genetic Testing for Your Symptoms

Over 5000 Mendelian and monogenic disorders are known. If you currently have a family history, or symptoms of a condition that may have a genetic origin, your physician can provide the clinical information when ordering the test.

Data analysis and clinical interpretation will be provided by Baylor Genetics to determine a genetic cause of your symptoms. This analysis covers mutations associated with pathogenic and likely-pathogenic variants, as well as variants of uncertain clinical significance.

The result is included as part of the physician report issued by a U.S. board-certified medical director from Baylor Genetics. Bilingual genetic counseling provided by U.S. certified genetic counselors is included. In addition, we also provide physician consultation. This is provided by U.S. board-certified physician specialists through live-video-conferencing sessions.


Your Heart Attack & Ischemic Stroke Risk

Myocardial Infarction (Heart Attack).  A heart attack occurs when the flow of blood to the heart is blocked, most often by a build-up of fat, cholesterol and other substances, which forms a plaque in the coronary arteries. The interrupted blood flow can damage the heart muscle. A heart attack, also called a myocardial infarction (MI), can be fatal.

Both environmental and genetic factors contribute to the risk of having a heart attack. The MI Risk Assessment Test determines the genotypes of two risk markers located at chromosome 9p21. These two single nucleotide polymorphisms, or SNPs, associate with increased risks for development of MI and coronary heart disease. The risk associations have been replicated in over 20 populations with over 20,000 myocardial infarction patients and 40,000 controls, including over 5000 Chinese, Japanese, Koreans and other East Asian patients.

Atrial Fibrillation (Ischemic Stroke) is an irregular and often rapid heart rate that can increase your risk of stroke, heart failure and other heart-related complications. Episodes of atrial fibrillation can lead to blood clots forming in the heart that may circulate to other organs and lead to blocked blood flow (ischemia).

A study of 471,446 Chinese individuals over 11 years, showed that the prevalence of atrial fibrillation (AF) increased 20 folds. The lifetime risk was approximately one in five among Chinese. The AF Risk Assessment Test determines the genotypes of two risk markers located at chromosome 4q25 near transcription factor PITX2.

In numerous studies with over 10,000 patients and 30,000 controls, the 4q25 risk association has been confirmed in Caucasian, Japanese, Chinese and Korean populations.

Clinical interpretation is provided by the Rainbow's clinical team in Japan.


Your Genetic Counseling Session

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Genetic Counseling for Patients.  Rainbow Genomics provides a variety of bilingual-genetic counseling services to our patients, in Mandarin, Cantonese, Japanese and English. Included with our tests, Baylor College of Medicine's Consultagene program delivers email-, phone- or video-conferencing-based genetic counseling to each patient. U.S.-certified genetic counselors from Baylor College of Medicine will provide the services to ensure high quality and effective patient support. 

Physician Consultation - Peer-to-Peer Discussions.  Rainbow Genomics also delivers two levels of support for ordering physicians to enhance their ability to provide the best care to their patients. Baylor Genetics' board-certified genetic counselors will provide email-based consultation to physicians. For clinicians who desire in-depth discussions of a patient's case, Baylor College of Medicine Consultagene program provides a peer-to-peer consultation, an one-hour, video-conferencing delivered directly by Baylor's physicians. The ordering clinician, their collaborators and associated health care providers are all welcome to participate.


How It Works

 
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The process starts with a physician office visit at a Rainbow-authorized clinic. The clinician will order the test for the patient.

Your DNA sample will be sequenced at a CAP-accredited or CLIA-certified laboratory. 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.

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.

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Is This Test Right For You?

Even if you have genetic mutations, or such mutation exists in your family, it does not necessarily mean that you will develop genetic disorders. Counseling by a certified genetic counselor is critical for you to understand the implications of carrying certain genetic variants.

The Rainbow Adult Screening Exome Sequencing test may be right for you if -

  • You are healthy and would like to understand your future risk of developing genetic disorders including hereditary cancers and heart diseases
  • You are planning to have children and would like to understand your risk of passing on a genetic disorder to your children
  • You would like to understand your drug response to over 340 medications

This test may not be right for you if -

  • You already have severe symptoms and you would like to determine the genetic cause.
    • For example, you have already been diagnosed with cancer. You and your physician would like to determine the genetic etiology of the cancer, that is, if the cancer is familial in nature ( a hereditary form of cancer). In this case, you should consider ordering the Rainbow High-Risk Cancer test.
  • You and your physician are looking for an exhaustive diagnostic genetic test.
    • For example, if your child is suffering from muscular dystrophy symptoms and your physician would like to determine a genetic cause. You should consider ordering the Rainbow Pediatric Care test which will analyze the entire 22,000 genes of your child's exome to determine causative mutations.

Physician Order Required


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Understand Your Drug Response To 340+ Medication

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Understand Your Drug Response To 340+ Medication

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Results Can Save Your Life In A Medical Emergency

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Results Can Save Your Life In A Medical Emergency

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OneOme


OneOme RightMed Test

OneOme


OneOme RightMed Test

Introduction

Pharmacogenomic (PGx) testing identifies how your genes affect your response to medications. Getting a PGx test may help your physician adjust your medications to be more effective for you.  

When you take a medication, your body’s response is determined by many factors, including your gender, weight, age, diet, other medications, any medical conditions, and exposure to environmental agents such as cigarette smoke.

Your genetic makeup can also have a major influence. In fact, genetic factors can account for up to 95% of how you respond to medications.  Genes are sections of DNA, and variations in your DNA are what make you unique. The different versions of a gene you inherit from your mother and father can determine everything from your eye color to how quickly you process, or metabolize medications.

Depending on your genes, your body may break down a drug too slowly or too quickly. If you metabolize a drug too slowly, you may be exposed to too much of it, which may result in an adverse drug reaction (ADR). If you metabolize a drug too quickly, you may not get
enough to have any effect at all.


Rainbow Genomics works closely with OneOme (Minneapolis, MN, U.S,) to provide comprehensive, clinically- actionable pharmacogenomic test to patients and physicians - The OneOme® RightMed® pharmacogenomic test. The OneOme® solution was co-developed and exclusively licensed from Mayo Clinic to bring pharmacogenomics into routine clinical care. The OneOme RightMed pharmacogenomic test is currently in use by Mayo Clinic Center for Individualized Medicine and many other hospitals and clinics around the world.


OneOme® RightMed® test

Genetic factors can account for up to 95% of drug-response variability and susceptibility (1). In other words, how a drug will—or won't—work for a particular individual.

Recent studies have demonstrated that > 90% of patients possess clinically actionable genetic variants that affect their drug response (2, 3).  The RightMed test can identify which inherited genetic variations a patient has to predict drug efficacy and metabolism and provide you with personalized recommendations for each of your patients.

The OneOme® RightMed® pharmacogenomic test is a cost-effective solution that determines how an individual patient’s genes may affect his/her response to medications. OneOme analyzes a patient’s genetic information and provides a validated clinical test report to help physicians and patients to make more precise and effective prescription decisions.

The RightMed test covers 22 genes, more than 340 medications, and 28 conditions.


Test Descriptions

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?

Everyone can benefit from the OneOme RightMed test. Your test results can be used over the course of your lifetime to help you make better prescription decisions for many different medical conditions.  While the RightMed test can provide insight for anyone, it’s particularly meaningful for patients who are taking:

  • MEDICATIONS THAT CAUSE UNWELCOME SIDE EFFECTS

  • MULTIPLE PRESCRIPTIONS

  • MEDICATIONS THAT ARE NOT WORKING

  • MEDICATIONS FOR ANY OF THE COVERED MEDICAL CONDITIONS




Physician Order Required


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Screen 20 Cancers

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Screen 20 Cancers

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Wellness Cancer


Rainbow Wellness Cancer Test

Wellness Cancer


Rainbow Wellness Cancer Test

Introduction

Cancer genetic predisposition is 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 Wellness Cancer Test

Two-in-One Test

Screening test.  The Rainbow Wellness Cancer test screens for genetic variations in 118 genes, covering over 20 types of cancers, including breast, ovarian, lung, colorectal, prostate, gastric and pancreatic cancers. This is a multi-cancer screening test designed for healthy individuals without cancer symptoms or family histories.

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.


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

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?

The Rainbow Wellness Cancer test is designed for healthy individuals who would like to understand their future risk of developing hereditary cancers.

If you already have cancer symptoms or a family history that suggests an inherited cancer risk condition, or you have several close relatives with the same type of cancer, you should consult with your physician to order the Rainbow High-Risk Cancer test, which is designed as a diagnostic test based on your symptoms and family history.




Physician Order Required


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Heart Attack Risk

 

 

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Heart Attack Risk

 

 

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Atrial Fibrillation (Ischemic Stroke) Risk

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Atrial Fibrillation (Ischemic Stroke) Risk

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AF & MI


Rainbow AF & MI Risk Assessment Test

AF & MI


Rainbow AF & MI Risk Assessment Test

Introduction to Myocardial Infarction 

A heart attack occurs when the flow of blood to the heart is blocked, most often by a build-up of fat, cholesterol and other substances, which forms a plaque in the coronary arteries. The interrupted blood flow can damage part of the heart muscle. A heart attack, also called a myocardial infarction (MI), can be fatal.  Both environmental and genetic factors contribute to the risk of having a heart attack.  

During a heart attack, one of these plaques can rupture and spill cholesterol and other substances into the bloodstream. A blood clot forms at the site of the rupture. If large enough, the clot can completely block the flow of blood through the coronary artery. 


Rainbow Myocardial Infarction Risk Assessment Test

The Myocardial Infarction Risk Assessment Test determines the genotypes of two risk markers located at chromosome 9p21.  These two single nucleotide polymorphisms, or SNPs, associate with increased risks for development of myocardial infarction (heart attack) and coronary heart disease.  The risk associations have been replicated in over 20 populations with over 20,000 myocardial infarction patients and 40,000 controls, including over 5000 Chinese, Japanese, Korean and other East Asian patients.

These population-based genetic risks have been shown to be independent of family history or traditional risk factors, including diabetes, hypertension, cholesterol, and obesity. Although the relative risks associated with these markers are not high, the population attributable risk is substantial due to the high frequency of carriers with the risk-associated variants.  Risk assessment outcome may have implications for early prevention of the disease. 


Introduction to Atrial Fibrillation 

Atrial fibrillation (AF) is an irregular and often rapid heart rate that can increase your risk of stroke, heart failure and other heart-related complications.

In atrial fibrillation, the heart's two upper chambers (the atria) beat chaotically and irregularly — out of coordination with the two lower chambers (the ventricles) of the heart.  The upper chambers of your heart (atria) experience chaotic electrical signals. As a result, they quiver. The atrioventricular node — the electrical connection between the atria and the ventricles — is bombarded with impulses trying to get through to the ventricles. Atrial fibrillation symptoms often include heart palpitations, shortness of breath and weakness.

The result is a fast and irregular heart rhythm. The heart rate in atrial fibrillation may range from 100 to 175 beats a minute. The normal range for a heart rate is 60 to 100 beats a minute.

Episodes of atrial fibrillation can come and go, or you may develop atrial fibrillation that doesn't go away and may require treatment. Although atrial fibrillation itself usually isn't life-threatening, it is a serious medical condition that sometimes requires emergency treatment.

Atrial fibrillation can lead to blood clots forming in the heart that may circulate to other organs and lead to blocked blood flow (ischemia).


Rainbow Atrial Fibrillation Risk Assessment Test

Genome-wide association studies have successfully identified chromosome 4q25 near transcription factor PITX2. The PITX2 locus encodes a transcription factor necessary for pulmonary myocardial sleeves development, and for the formation of a sinus node in the left atrium. In numerous follow-up studies with over 10,000 patients and 30,000 controls, the chromosome 4q25 risk association has been confirmed in Caucasian, Japanese, Chinese and Korean populations. 

In this test, two SNPs located adjacent to the PITX2 gene were both tested for the presence of the at-risk allele.  Carriers of this allele at either locations are at a higher risk of AF compared to that of the general population. 


Test Descriptions

The process starts with a physician office visit at a Rainbow-authorized clinic. The clinician will order the test for the patient.  DNA will be sequenced using Sanger sequencing methods at a CAP-accredited or CLIA-certified Laboratory with current ABI 3730 DNA sequencing systems.  

Data analysis will be performed by the clinical and bioinformatics team at Juntendo University, Japan. Based on the allele calls and multiple publications of the lifetime risks associated with specific ethnic populations, our team determines the risk levels associated with the genotypes of the SNPs for each condition based on the patient’s specific ethnicity. A physician report will be issued by one of the medical directors at Juntendo University, Japan. 



References

  1. Genetic Risk, Adherence to a Healthy Lifestyle, and Coronary Disease. N Engl J Med. 2016 Dec 15;375 (24):2349-2358. 
  2. Genetics of coronary artery disease and myocardial infarction. World J Cardiol 2016 January 26; 8(1): 1-23
  3. A common variant on chromosome 9p21 affects the risk of myocardial infarction.  Science. 2007 Jun 8;316(5830):1491-3.
  4. Association between 9p21.3 genomic markers and coronary artery disease in East Asians: a meta analysis involving 9,813 cases and 10,710 controls.  Mol Biol Rep (2013) 40: 337.
  5. The same sequence variant on 9p21 associates with myocardial infarction, abdominal aortic aneurysm and intracranial aneurysm. Nat Genet. 2008 Feb;40(2):217-24.
  6. Associations Between Single Nucleotide Polymorphisms on Chromosome 9p21 and Risk of Coronary Heart Disease in Chinese Han Population.  Arterioscler. Thromb. Vasc. Biol. 2008;28;2085-2089.
  7. Risk variants for atrial fibrillation on chromosome 4q25 associate with ischemic stroke.  Ann Neurol. 2008 Oct;64(4):402-9.
  8. Assessment of association of rs2200733 on chromosome 4q25 with atrial fibrillation and ischemic stroke in a Chinese Han population.  Hum Genet. 2009 Dec;126(6):843-9.
  9. Replication of the association between a chromosome 9p21 polymorphism and coronary artery disease in Japanese and Korean populations.  J Hum Genet (2008) 53:357–359.
  10. Variants conferring risk of atrial fibrillation on chromosome 4q25.  Nature. 2007 Jul 19;448(7151):353-7.
  11. Association between 9p21.3 genomic markers and coronary artery disease in East Asians: a meta-analysis involving 9,813 cases and 10,710 controls.  Mol Biol Rep. 2013 Jan;40(1):337-43.
  12. 9p21 and the genetic revolution for coronary artery disease.  Clin Chem. 2012 Jan;58(1):104-12.

Physician Order Required