N/A N=300 Clinical Protocol SeCore, uTYPE and 3500 Dx System
Human Leukocyte Antigens (HLA)
Primary: All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) — 99.6 percentage of concordant alleles
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=327 Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing
Genotyping Techniques
Primary: Percent Agreement — 100; 100; 100; 100 Percent Agreement
N/A N=12,550 Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Herpes Simplex Virus
Primary: Sensitivity of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From the Genital Tract of Non-pregnant Women in STI Clinics, as Compared With HSV Culture…
N/A N=145 Evaluation of Low-cost Techniques for Detecting Sickle Cell Disease and β-thalassemia in Nepal and Canada
Sickle Cell Disease · Sickle Cell Trait · Beta-Thalassemia
Primary: Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value — 96.6; 100; 0; 91.3 percentage
N/A N=236 LeukoSEQ: Whole Genome Sequencing as a First-Line Diagnostic Tool for Leukodystrophies
Leukodystrophy · White Matter Disease · 4H Syndrome
Primary: Changes in Diagnosis Status (Resulting From WGS) — 45 Participants
N/A N=24 Smokers' Response to Nicotine Dependence Genotyping
Cigarette Smoking · Nicotine Dependence
Primary: Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results — 1; 0; 7; 11 Participants
N/A N=227 Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
Depression
Primary: Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline — -41.2; -11.0; -48.4; -31.8 Percentage change in depression rating…
N/A N=263 Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Venous Thromboembolism · Bleeding
Primary: The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement — 2; 4 participants
N/A N=509 Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention
Acute Coronary Syndrome · Cardiovascular Diseases
Primary: The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor — 174; 201; 75; 54 Participants — p=0.03
N/A N=148 Implementation of Genomics in Substance Use Disorder Treatment
Tobacco Use Disorder · Smoking Cessation · Tobacco Use Cessation
Primary: Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days — 11; 9; 9; 2 Participants
Phase 2 N=135 Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Rectal Carcinoma
Primary: Rate of Tumor Downstaging Compared With Historical Controls. — 64.4; 64.5 percentage of participants
N/A N=531 Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
Gastrointestinal Cancer
Primary: Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose — 130; 95 Participants
Phase 2 N=100 Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
Colon Cancer
Primary: Progression Free Survival — 38; 34; 6; 3 Participants
Phase 2 N=19 Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial
Congenital Bleeding Disorder · Haemophilia A With Inhibitors · Haemophilia B With Inhibitors
Primary: Determination of HLA Type — 15; 5; 5; 1 subjects
N/A N=2,767 Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
Neisseria Gonorrhoeae Infection · Chlamydia Trachomatis Infection · Sexually Transmitted Infections
Primary: Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria…
N/A N=8 Spartan FRX Project Reproducibility Study
Analytical Reproducibility of a Medical Device
Primary: Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System. — 98.3; 100; 97.5; 99.2 Percentage of Correct Calls
Phase 4 N=105 Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
Pain · Other Surgical Procedures · Impacted Third Molar Tooth
Primary: Score of Pain Measured by Visual Analogue Scale — 25 score on a scale (mm)
N/A N=477 South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
Whole Genome Sequencing
Primary: Evaluate Parental Empowerment Using the Genetic Counseling Outcome Scale (GCOS) — 117.94; 117.19 score on a scale
N/A N=383 Clinical Implementation of Carrier Status Using Next Generation Sequencing
Genetic Disorders
Primary: Number of Patients That Receive Carrier Testing and Have Results to Return — 9; 155 Participants
N/A N=190 Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Pharmacogenetics
Primary: Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting — 14; 13 Participants
Phase 4 N=28 Implementation of PPI Medication PGX Testing
Gastroesophageal Reflux
Primary: Count of Patients Agreeing to Volunteer for the Study — 28 Participants
N/A N=110 Pharmacogenetic Testing Among Home Health Patients
Adverse Drug Events · Adverse Drug Reactions · Drug Interaction Potentiation
Primary: Number of Re-hospitalizations at 30 and 60 Days — 0.38; 0.25; 0.7; 0.33 Re-hospitalizations — p=0.21
N/A N=88 Pharmacogenetics of b2-Agonists in Asthma.
Asthma
Primary: Log10 PC20 to Methacholine After Visit 2 — 0.54; 0.48; 0.16; 0.53 log10 mg/mL — p=0.27
N/A N=15 Human Papillomatosis Genotyping of Children in Thailand
Recurrent Laryngeal Papillomatosis · Human Papilloma Virus
Primary: Human Papillomavirus Genotypes — 6; 9 participants
N/A N=2,050 Genetic Testing to Understand and Address Renal Disease Disparities
Hypertension · Chronic Kidney Disease · Genomics
Primary: Number of Participants With Urine Protein Excretion — 33; 278; 39; 50 Participants
Phase 4 N=31 Genetics and HIV-1 Protease Inhibitors
HIV
Primary: Day 7 Atazanavir Oral Clearance — .25; .18 L/h/kg
N/A N=601 Genetic Testing for Type 2 Diabetes
Diabetes Mellitus
Primary: Weight — 103.8; 100.7 kg — p=0.44
N/A N=943 Co-receptor Tropism Determination of HIV-1 Subtype A Spread in the Russian Federation Using V3-based Genotyping Tools
HIV Infection
Primary: Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia — 123; 85; 114; 78 participants
N/A N=5 Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Primary: Number of LDLR Gene Mutations — 7 gene mutations
N/A N=6 VircapSeq Virus Detection in Sézary Syndrome
Lymphoma, T-Cell, Cutaneous · Sézary Syndrome
Primary: Number of Participants With Viral Sequences Present in Malignant T Cells of Patients With Sézary Syndrome — 6 Participants