Tufts-New England Medical Center and Source MDx Announce Collaboration
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Tufts-New England Medical Center and Source MDx, Boulder, CO. have announced a collaboration to develop a molecular diagnostic test for Rheumatoid Arthritis.
Researchers at Tufts-NEMC, led by co-principal investigator, Tim McAlindon, MD, Chief of Rheumatology at Tufts-NEMC, will manage the clinical studies for a molecular diagnostic test that will characterize Rheumatoid Arthritis patients and their response to anti-TNF therapy.
Source MDx will provide gene expression analysis of whole blood samples from the approximately 100 participating patient population based on its patented RA Precision Profile™ gene panel designed to diagnose and monitor RA patients and its Healthy Normals Reference dataset. Lisa Siconolfi, Ph.D., Director, Clinical Studies is the co-principal investigator for Source MDx.
"A test that provides the earliest warning of disease activity can help prompt appropriate therapy to mitigate long-term damage," said Tim McAlindon, M.D.
"The earlier Rheumatoid Arthritis is detected and treated the less permanent joint damage a patient will have."
In conjunction with the Tufts-NEMC study, Source MDx also announced that it has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health to initiate the development of a molecular diagnostic test using biomarkers to predict responders and non- responders to anti-tumor neurosis factor therapy for Rheumatoid Arthritis.
"We are pleased that the National Institutes of Health continues to recognize the potential impact of Source MDx's enabling technology in the development of RNA-based molecular diagnostics," said Lisa Siconolfi, Ph.D.
"In particular, it is gratifying that others in the scientific field appreciate the importance of Source MDx's precise gene expression and ability to compare to a healthy normal range when developing clinical applicable biomarkers of disease," she continued.
The grant provides over $195,000 in funding over a one-year period. This is the sixth SBIR grant Source MDx has received.
Given that current tests lack adequate predictive value, Source MDx will address the need for a screening and monitoring test that can predict an RA patient's future course and response to treatment.
A predictive test will allow early intervention before significant joint and/or organ deterioration has occurred and will allow adjustment of medications that are/are not effective.
Source MDx claims that, Company will use the SBIR funds to begin to develop a test that identifies patients that will respond best to a defined treatment regimen beginning with characterizing patient response anti-TNF therapy.
By analyzing biomarkers in whole blood collected from RA patients, Source MDx has already been able to discriminate healthy individuals from patients with RA.
Using the same process of patented biomarker analysis Source MDx will address treatment effectiveness, to determine if a therapy is moving the patient towards a more healthy expression profile.
The development of useful RNA-based biomarkers for molecular diagnostics has been inhibited in the past by the inability to measure gene expression with sufficient precision, as well as the presumption that gene expression is too variable within and between individuals.
Source MDx's patented assay technology is designed to enable the measurement of gene-expression responses.
The proprietary technology has been able to define disease- specific biomarker patterns in blood for several diseases and is therefore well-positioned to define biomarkers for patient response to TNF-alpha therapy.
Researchers at Tufts-NEMC, led by co-principal investigator, Tim McAlindon, MD, Chief of Rheumatology at Tufts-NEMC, will manage the clinical studies for a molecular diagnostic test that will characterize Rheumatoid Arthritis patients and their response to anti-TNF therapy.
Source MDx will provide gene expression analysis of whole blood samples from the approximately 100 participating patient population based on its patented RA Precision Profile™ gene panel designed to diagnose and monitor RA patients and its Healthy Normals Reference dataset. Lisa Siconolfi, Ph.D., Director, Clinical Studies is the co-principal investigator for Source MDx.
"A test that provides the earliest warning of disease activity can help prompt appropriate therapy to mitigate long-term damage," said Tim McAlindon, M.D.
"The earlier Rheumatoid Arthritis is detected and treated the less permanent joint damage a patient will have."
In conjunction with the Tufts-NEMC study, Source MDx also announced that it has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health to initiate the development of a molecular diagnostic test using biomarkers to predict responders and non- responders to anti-tumor neurosis factor therapy for Rheumatoid Arthritis.
"We are pleased that the National Institutes of Health continues to recognize the potential impact of Source MDx's enabling technology in the development of RNA-based molecular diagnostics," said Lisa Siconolfi, Ph.D.
"In particular, it is gratifying that others in the scientific field appreciate the importance of Source MDx's precise gene expression and ability to compare to a healthy normal range when developing clinical applicable biomarkers of disease," she continued.
The grant provides over $195,000 in funding over a one-year period. This is the sixth SBIR grant Source MDx has received.
Given that current tests lack adequate predictive value, Source MDx will address the need for a screening and monitoring test that can predict an RA patient's future course and response to treatment.
A predictive test will allow early intervention before significant joint and/or organ deterioration has occurred and will allow adjustment of medications that are/are not effective.
Source MDx claims that, Company will use the SBIR funds to begin to develop a test that identifies patients that will respond best to a defined treatment regimen beginning with characterizing patient response anti-TNF therapy.
By analyzing biomarkers in whole blood collected from RA patients, Source MDx has already been able to discriminate healthy individuals from patients with RA.
Using the same process of patented biomarker analysis Source MDx will address treatment effectiveness, to determine if a therapy is moving the patient towards a more healthy expression profile.
The development of useful RNA-based biomarkers for molecular diagnostics has been inhibited in the past by the inability to measure gene expression with sufficient precision, as well as the presumption that gene expression is too variable within and between individuals.
Source MDx's patented assay technology is designed to enable the measurement of gene-expression responses.
The proprietary technology has been able to define disease- specific biomarker patterns in blood for several diseases and is therefore well-positioned to define biomarkers for patient response to TNF-alpha therapy.
