DioGenix Reports Positive Results for Next-Gen MS Test
Diagnostic gives doctors ability to rapidly diagnose multiple sclerosis and get patients on treatment sooner.
MARIE DAGHLIAN
The Burrill Report
“It has the potential to ease the strain on the healthcare system and improve patient outcomes by identifying which patients really need to be on MS therapy and which ones do not, says Tiffany.”
DioGenix reported positive new data from a prospective study supporting the clinical validation of its next-generation sequencing diagnostic to identify patients with multiple sclerosis at first clinical presentation. The test met its primary endpoint of demonstrating its ability to make an MS diagnosis correctly in 82 percent of cases, consistent with previous studies and while maintaining sensitivity comparable to the current standard of care. Called MSPrecise, the test measures DNA mutations found in rearranged immunoglobulin genes in immune cells initially isolated from cerebrospinal fluid.
Multiple sclerosis is a debilitating neurological autoimmune disease in which the body attacks the protective insulation around nerve cells called myelin, causing scarring and ultimately severing the connections between nerve cells. It affects twice as many women as men, mostly when they are between the ages of 30 and 40 and there are about 2.3 million people with the disease worldwide, according to the National Multiple Sclerosis Society. Up to now it has been very difficult to diagnose MS quickly as early symptoms vary from patient to patient and are consistent with the symptoms of many other neurological diseases, making confirmation of MS that much more difficult.
On the other hand, there are now several treatments on the market that while not a cure, do a good job of treating the symptoms and slowing the disease’s progression, especially if treatment is started soon after the disease’s onset. DioGenix’s test “hones in on immune-mediated neurological diseases to provide physicians and patients with more rapid and definitive answers, as the current battery of tests can take months to years based on the current standard of care,” says Larry Tiffany, president and CEO of DioGenix.
“It has the potential to ease the strain on the healthcare system and improve patient outcomes by identifying which patients really need to be on MS therapy and which ones do not, as every false positive is expensive and every false negative can delay treatment that would slow permanent disability,” Tiffany says.
The latest trial of MSPrecise was the largest-ever prospective study evaluating a diagnostic in MS, according to Tiffany. The 200 treatment naïve subjects enrolled in the blinded trial were being evaluated for non-specific neurological symptoms that could be MS. Each subject was undergoing a comprehensive evaluation using the current standard of care for imaging of the central nervous system and analysis of their cerebral spinal fluid and blood. The study compared the results of MSPrecise DNA mutational analysis with a consensus diagnosis made by a panel of independent neurologists chosen for their significant clinical experience in diagnosing and treating MS. The MSPrecise interpretive scoring system provides a simple scaled score to the neurologist who differentiates patients with MS from those with other similarly presenting neurological diseases. Thirteen MS clinical centers of excellence participated in the trial with more than 20 expert clinicians consenting subjects. Results from this study will be submitted for peer review.
“MSPrecise interrogates key genes involved in the immune system of patients being evaluated for MS. The growing body of evidence indicates this next-generation sequencing assay may advance our efforts to more accurately diagnose patients with MS or other immune-mediated neurological disease,” says Elliot Frohman, director of the MS Program and Clinical Center for MS at the University of Texas Southwestern Medical Center.
Gaithersburg, Maryland-based DioGenix got its start as the genomics unit spun out of GeneLogic in late 2008 with a focus on finding biomarkers of neurodegenerative diseases and building tests around them. It signed the term sheet for its first round of financing in September 2008, the day Lehman brothers announced it had filed for bankruptcy. The money came from Nerveda, a group of high net worth individuals that had a special interest in developing predictive tests for neurological diseases. The technology underpinning MSPrecise was licensed from Nancy Munson’s research at the University of Texas Southwestern Medical Center.
DioGenix is also looking to see if the same DNA mutation signature that it measures in cerebral spinal fluid can be readily detected in blood. That research is being supported by Fast Forward, a subsidiary of the National Multiple Sclerosis Society.
With positive results in hand, the company has a green light to begin pre-commercial activities, Tiffany says, and hopefully soon help inform more appropriate courses of treatment for people suffering from immune-mediated neurological diseases.
Diagnostic gives doctors ability to rapidly diagnose multiple sclerosis and get patients on treatment sooner.
MARIE DAGHLIAN
The Burrill Report
“It has the potential to ease the strain on the healthcare system and improve patient outcomes by identifying which patients really need to be on MS therapy and which ones do not, says Tiffany.”
DioGenix reported positive new data from a prospective study supporting the clinical validation of its next-generation sequencing diagnostic to identify patients with multiple sclerosis at first clinical presentation. The test met its primary endpoint of demonstrating its ability to make an MS diagnosis correctly in 82 percent of cases, consistent with previous studies and while maintaining sensitivity comparable to the current standard of care. Called MSPrecise, the test measures DNA mutations found in rearranged immunoglobulin genes in immune cells initially isolated from cerebrospinal fluid.
Multiple sclerosis is a debilitating neurological autoimmune disease in which the body attacks the protective insulation around nerve cells called myelin, causing scarring and ultimately severing the connections between nerve cells. It affects twice as many women as men, mostly when they are between the ages of 30 and 40 and there are about 2.3 million people with the disease worldwide, according to the National Multiple Sclerosis Society. Up to now it has been very difficult to diagnose MS quickly as early symptoms vary from patient to patient and are consistent with the symptoms of many other neurological diseases, making confirmation of MS that much more difficult.
On the other hand, there are now several treatments on the market that while not a cure, do a good job of treating the symptoms and slowing the disease’s progression, especially if treatment is started soon after the disease’s onset. DioGenix’s test “hones in on immune-mediated neurological diseases to provide physicians and patients with more rapid and definitive answers, as the current battery of tests can take months to years based on the current standard of care,” says Larry Tiffany, president and CEO of DioGenix.
“It has the potential to ease the strain on the healthcare system and improve patient outcomes by identifying which patients really need to be on MS therapy and which ones do not, as every false positive is expensive and every false negative can delay treatment that would slow permanent disability,” Tiffany says.
The latest trial of MSPrecise was the largest-ever prospective study evaluating a diagnostic in MS, according to Tiffany. The 200 treatment naïve subjects enrolled in the blinded trial were being evaluated for non-specific neurological symptoms that could be MS. Each subject was undergoing a comprehensive evaluation using the current standard of care for imaging of the central nervous system and analysis of their cerebral spinal fluid and blood. The study compared the results of MSPrecise DNA mutational analysis with a consensus diagnosis made by a panel of independent neurologists chosen for their significant clinical experience in diagnosing and treating MS. The MSPrecise interpretive scoring system provides a simple scaled score to the neurologist who differentiates patients with MS from those with other similarly presenting neurological diseases. Thirteen MS clinical centers of excellence participated in the trial with more than 20 expert clinicians consenting subjects. Results from this study will be submitted for peer review.
“MSPrecise interrogates key genes involved in the immune system of patients being evaluated for MS. The growing body of evidence indicates this next-generation sequencing assay may advance our efforts to more accurately diagnose patients with MS or other immune-mediated neurological disease,” says Elliot Frohman, director of the MS Program and Clinical Center for MS at the University of Texas Southwestern Medical Center.
Gaithersburg, Maryland-based DioGenix got its start as the genomics unit spun out of GeneLogic in late 2008 with a focus on finding biomarkers of neurodegenerative diseases and building tests around them. It signed the term sheet for its first round of financing in September 2008, the day Lehman brothers announced it had filed for bankruptcy. The money came from Nerveda, a group of high net worth individuals that had a special interest in developing predictive tests for neurological diseases. The technology underpinning MSPrecise was licensed from Nancy Munson’s research at the University of Texas Southwestern Medical Center.
DioGenix is also looking to see if the same DNA mutation signature that it measures in cerebral spinal fluid can be readily detected in blood. That research is being supported by Fast Forward, a subsidiary of the National Multiple Sclerosis Society.
With positive results in hand, the company has a green light to begin pre-commercial activities, Tiffany says, and hopefully soon help inform more appropriate courses of treatment for people suffering from immune-mediated neurological diseases.
