Assay Design and Products

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MyHap2 is an in office or physician directed at-home test performed via fingerstick. The assay is a Lateral Flow Quantum Dot Immunoassay intended to screen for the high risk haptoglobin variant (Hp2-2). Patients testing positive for the high risk variant should see their physician for confirmatory testing with the Hap2 clinical assay.  MyHap2 is intended as a rapid screen only and not a diagnostic or means for diagnosing any disease or disease state.  

This patent pending design is easy to administer, low cost, has high accuracy and can rapidly screen patient populations for genetic variants of significance in endocrinology, cardiovascular medicine, gastroenterology, infectious disease and neurology.  For more information visit www.myhap2.com

Hap2 is a multiplex assay designed as a clinical grade confirmatory screen following the MyHap2 rapid screen.  The assay contains multiple patent pending methods for examining biological markers potentially important in the development of Diabetes, Heart Disease, Infection, Leaky Gut, NASH, Stroke and General Oxidative Stress.  This multiplex assay is performed on blood, plasma, serum, saliva, or tissue in CLIA and/or CAP accredited laboratories to aid physicians in the course of treatment and risk assessment. Principal therapeutic areas are endocrinology, cardiovascular medicine, neurology, infectious disease and gastroenterology. 

PerioIQ (Trademark Pending) is a multiplex assay designed as a clinical grade assay and screen for periodontal disease and inflammation.  The assay contains multiple patent pending methods for examining 32 bacterial, viral, fungal and proinflammatory signatures within the oral cavity and oral biofilm.  These markers have been shown to be important in the development of periodontal disease and systemic disease. Periodontal disease has a clear connection and direct impact medical complications such as Diabetes, Heart Disease, and Stroke. This multiplex assay is performed on saliva, crevicular fluid or tissue in CLIA and/or CAP accredited laboratories to aid dental and medical providers in the course of treatment and risk assessment. Principal therapeutic areas are general dentistry, periodontistry and in collaboration with endocrinology, cardiovascular medicine, neurology, and infectious disease. 

WoundIQ (Trademark Pending) is a multiplex assay designed as a clinical grade assay to screen for infections in chronic wounds.  The assay contains multiple patent pending methods for examining 64 bacterial, viral, and fungal targets, microbial resistance and proinflammatory signatures within the Wound and Wound biofilms.  These markers have been shown to be important in the development of non-healing wounds and systemic disease. Non-healing wounds are a significant problem in diabetes, oncology, venous and peripheral artery disease.  This multiplex assay is performed on biofilm and tissue samples in CLIA and CAP accredited laboratories to aid medical providers in the course of treatment and risk assessment. Principal therapeutic areas are general podiatry, vascular medicine, and wound clinics in collaboration with endocrinology, cardiovascular medicine, oncology, and infectious disease.

RespIQ (Trademark Pending) is a multiplex assay designed as a clinical grade assay and screen for infections in chronic wounds.  The assay contains multiple patent pending methods for examining 54 bacterial, viral, fungal targets, microbial resistance and pro-inflammatory signatures within the respiratory secretion, bronchial lavage and and respiratory biofilms.  These markers have been shown to be important in the development of non-healing wounds and systemic disease. Non-healing wounds are a significant problem in diabetes, venous and peripheral artery disease. This multiplex assay is performed on nasopharageal swabs,sputum,  biofilm, bronchial lavage and brushings and tissue samples in CLIA and CAP accredited laboratories to aid medical providers in course of treatment and risk assessment. Principal therapeutic areas are general pulmonology, pediatrics, geriatrics and in collaboration with endocrinology, cardiovascular medicine, neurology, and infectious disease. 

CompleteIQ (Trademark Pending) is a multiplex assay designed as a clinical grade assay and screen for a broad range of infectious agents.  The assay contains multiple patent pending methods for examining 152 bacterial, viral, fungal targets, microbial resistance markers and pro-inflammatory signatures within the clinical patient samples.  This multiplex assay is performed on blood, saliva,  biofilm and tissue samples in CLIA and CAP accredited laboratories to aid medical providers in course of treatment and risk assessment. Principal therapeutic areas are general family medicine, geriatrics, internal medicine, LTC and in collaboration with endocrinology, cardiovascular medicine, neurology, and infectious disease. 

VetArrayIQ (Trademark Pending) is a multiplex assay designed as a clinical grade assay and screen for use in veterinary offices to diagnose infectious disease. The assay contains multiple patent pending methods for examining bacterial, viral, fungal, microbial resistance markers and pro-inflammatory signatures within domestic pets and service animals with a high density multiplexed microarray. This multiplex assay is performed on saliva, synovial fluid, blood, wound exudate or tissue as a point of care assay in veterinary clinics to aid veterinary providers in the best course of treatment and risk assessment. 

Vigerust, David J. A Rapid Screen for High Risk Haptoglobin Variants . U.S. Provisional Patent Application Pending.  

Vigerust, David J. A Multiplexed Means and Method for Determining Risk. U.S. Provisional Patent Application Pending.  

Vigerust, David J. A Method for Determination of Oxidative Stress. U.S. Provisional Patent Application 62/207018. 

Vigerust, David J. A Multiplexed Method for Determining Periodontal and Systemic Disease Risk. U.S. Provisional Patent Application Pending.

1. Vigerust DJ. Implications of Haptoglobin Genotype in Infectious Disease and Immunobiology. Immunobiology. Pending Submission

2. Vigerust DJ. Implications of Haptoglobin Genotype in Neuroinflammation and Stroke. Frontiers in Neurology. Pending Submission

3. Vigerust DJ. Role of Haptoglobin Genotype in Non-Alcoholic Fatty Livder Disease. Gastroenterology. Pending Submission

4. Doneen AL, Bale BF, Vigerust DJ, Leimgruber PP. Cardiovascular Prevention: Migrating from a Binary to a Ternary Classification. Frontiers in Cardiovascular Medicine. Submitted

5. Bale BF, Doneen AL, Vigerust DJ. Precision Healthcare of Type 2 Diabetic Patients Through Implementation of Haptoglobin Genotyping. Frontiers in Cardiovascular Medicine. 2018; 16(5): 141-145. PMID: 30386783

6. Bale BF, Doneen AL, Vigerust DJ. High Risk Periodontal Pathogens Contribute to the Pathogenesis of Atherosclerosis. Postgraduate Medical Journal. 2017; Apr; 93(1098): 215-220. PMID: 27899684.

7. Vigerust DJ. Clinical Importance of Haptoglobin Testing in Diabetes. Diabetes Management. 2016; 6(5): 95-98.

8. Mackellar M, Vigerust DJ. Role of Haptoglobin in Heath and Disease: A Focus on Diabetes.Clinical Diabetes. 2016; Jul; 34(3): 148-157. PMID: 27621532.

9. Graves KL, Vigerust DJ. Haptoglobin: An Inflammatory Indicator in Cardiovascular Disease.Future Cardiology. 2016; 12(4): 471-481.

PMID: 27203711.