SAN DIEGO, Nov. 7, 2016 /PRNewswire-USNewswire/ -- Genalyte Inc. an emerging clinical diagnostics company, will present the first-ever clinical abstracts for the Maverick™ Detection System at the 2016 American College of Rheumatology/ Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Washington, DC.
The Maverick Detection System is currently being evaluated at multiple global sites for potential use as a near-patient diagnostic platform capable of high multiplex, rapid time-to-result, auto-antibody testing.
"The Maverick system showed excellent total, positive, and negative percent agreement when compared to the final conclusions of the laboratory and may offer a tool for the rapid detection of auto-antibodies," said Dr. Makoto Miyara, who has been directing an independent validation of the Maverick Detection System at the Department of Immunology at the Pitié-Salpêtrière Hospital in Paris, France.
Dr. Smitha Reddy, a Board Certified Clinical Rheumatologist and Medical Director of the Arthritis Care and Research Center of San Diego, said a company-sponsored study demonstrated "the feasibility of performing multiplex ANA testing on whole blood in a near patient setting in an outpatient clinic." Dr. Reddy added, "There is high correlation between venous blood and finger-stick blood, and between positive and negative results on the Maverick and comparative devices."
Genalyte executives and investigators who have been evaluating the Maverick Detection System will be on site at the 2016 ACR/ARHP Annual meeting to discuss the Maverick Detection System and clinical data that will be first reported at the meeting.
Genalyte Related Abstracts at the 2016 ACR/ARHP Annual Meeting
Tuesday, November 15, 2016
Session: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster III: Biomarkers and Nephritis
Abstract Title: Near Patient Anti-Nuclear Antibody Multiplex Testing Using Whole Blood for the Diagnosis of Connective Tissue Diseases in a Tertiary Care Center
Presenter: Makoto Miyara, MD, PhD
Abstract #2848
Tuesday, November 15, 2016
Session: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster III: Biomarkers and Nephritis
Abstract Title: Application of a Novel Anti-Nuclear Antibody Multiplex Test Using Finger Stick and Venous Whole Blood in a Rheumatology Clinic – Demonstration of Feasibility
Presenter: Smitha Reddy, MD
Abstract #2846
Caution: The Maverick™ Detection System is an investigational device. Limited by Federal law to investigational and research use only. It is not approved for sale as an IVD in any market.
Media interested in speaking with Genalyte, or learning more about the two ACR presentations, please contact: [email protected]
About Genalyte Genalyte's vision is to transform the doctor-patient relationship by bringing the doctor, the patient, and the lab together to provide results when they matter: Now. Genalyte's platform is being designed with the goal of providing test results from a whole blood sample within fifteen minutes in the physician's office. Providing diagnostic results at the time and place they are needed – when the patient is sitting in front of the doctor—has the potential to empower physicians, improve quality of care for patients, and reduce resource utilization across the healthcare system.
Genalyte's technology is based on a proprietary silicon biosensor design that is currently in use by pharmaceutical companies, contract research organizations and academic researchers. For more information, visit www.genalyte.com.
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The Maverick Detection System is currently being evaluated at multiple global sites for potential use as a near-patient diagnostic platform capable of high multiplex, rapid time-to-result, auto-antibody testing.
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"The Maverick system showed excellent total, positive, and negative percent agreement when compared to the final conclusions of the laboratory and may offer a tool for the rapid detection of auto-antibodies," said Dr. Makoto Miyara, who has been directing an independent validation of the Maverick Detection System at the Department of Immunology at the Pitié-Salpêtrière Hospital in Paris, France.
Dr. Smitha Reddy, a Board Certified Clinical Rheumatologist and Medical Director of the Arthritis Care and Research Center of San Diego, said a company-sponsored study demonstrated "the feasibility of performing multiplex ANA testing on whole blood in a near patient setting in an outpatient clinic." Dr. Reddy added, "There is high correlation between venous blood and finger-stick blood, and between positive and negative results on the Maverick and comparative devices."
Genalyte executives and investigators who have been evaluating the Maverick Detection System will be on site at the 2016 ACR/ARHP Annual meeting to discuss the Maverick Detection System and clinical data that will be first reported at the meeting.
Genalyte Related Abstracts at the 2016 ACR/ARHP Annual Meeting
Tuesday, November 15, 2016
Session: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster III: Biomarkers and Nephritis
Abstract Title: Near Patient Anti-Nuclear Antibody Multiplex Testing Using Whole Blood for the Diagnosis of Connective Tissue Diseases in a Tertiary Care Center
Presenter: Makoto Miyara, MD, PhD
Abstract #2848
Tuesday, November 15, 2016
Session: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster III: Biomarkers and Nephritis
Abstract Title: Application of a Novel Anti-Nuclear Antibody Multiplex Test Using Finger Stick and Venous Whole Blood in a Rheumatology Clinic – Demonstration of Feasibility
Presenter: Smitha Reddy, MD
Abstract #2846
Caution: The Maverick™ Detection System is an investigational device. Limited by Federal law to investigational and research use only. It is not approved for sale as an IVD in any market.
Media interested in speaking with Genalyte, or learning more about the two ACR presentations, please contact: [email protected]
About Genalyte Genalyte's vision is to transform the doctor-patient relationship by bringing the doctor, the patient, and the lab together to provide results when they matter: Now. Genalyte's platform is being designed with the goal of providing test results from a whole blood sample within fifteen minutes in the physician's office. Providing diagnostic results at the time and place they are needed – when the patient is sitting in front of the doctor—has the potential to empower physicians, improve quality of care for patients, and reduce resource utilization across the healthcare system.
Genalyte's technology is based on a proprietary silicon biosensor design that is currently in use by pharmaceutical companies, contract research organizations and academic researchers. For more information, visit www.genalyte.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/first-ever-clinical-results-for-rapid-near-patient-diagnostics-platform-to-be-presented-at-acrarhp-annual-meeting-300358606.html
SOURCE Genalyte Inc.
