A new diagnostic test for Alzheimer’s that only requires a skin sample will soon be available for patients in and around Dallas and Fort Worth, Texas.
Dallas/Fort Worth is the first market that Synaps Dx has announced for its DISCERN product, a minimally invasive Alzheimer’s test that’s being marketed as a first-of-its-kind test for the disease, which affects about five million people in the United States.
No timeline has been announced for the launch, but Synaps Dx has added a Dallas-area businessman active in health care to its board of directors. The company said the Dallas/Fort Worth metro area will be “among the first in the country” where DISCERN is commercially available, signaling availability in other markets may be on the way.
Frank Amato, CEO and president of Synaps Dx, said the state of Texas has almost 400,000 cases of Alzheimer’s and there’s interest in the technology in the Dallas/Fort Worth area.
“We selected Texas as the first region for the commercial launch of DISCERN based upon this high need and the proactive strategies that the state has undertaken,” Amato said in a statement. “We already have significant interest throughout the Dallas medical community for DISCERN.”
The test primarily uses morphometric imaging to identify abnormalities in skin cells consistent with dementia. The skin sample used for the test is about three millimeters in size and is taken at the same time as a blood sample. Test kits are sent directly to doctors who can administer them to patients before sending them to a lab for testing.
The Maryland-based company claims its tests are 95% accurate, based on trials and studies including patients’ autopsy results. The test has Breakthrough Designation from the U.S. Food and Drug Administration, which means it could receive priority review for approval and is being developed with input from the FDA.
Synaps Dx has a questionnaire on its website meant to identify patients who may be in need of diagnostic work for Alzheimer’s. Earlier this month, the company opened a lab in North Bethesda, Maryland as a central location to receive and test samples. Samples must be taken in a doctor’s office, and the company said results can be ready in seven to eight weeks.
A contributing factor to picking north Texas as the first market for the test is the Texas State Plan for Alzheimer’s Disease 2019-2023, a state program that emphasizes a public health approach to preventing and treating Alzheimer’s. According to the plan’s text, this includes widely available diagnostics for Alzheimer’s and other forms of dementia.
“Communities across the nation are moving toward a public health approach to address Alzheimer’s disease and other dementias,” the state plan reads. “Public health involves organized efforts to prevent, detect and respond to health risks at a community level. For Alzheimer’s disease and other dementias, this means addressing challenges among aging individuals and the wider population. Alzheimer’s disease and other dementias are a public health issue because of the large financial impact on society, the burden on families and facilities to provide care, and because there are ways to intervene over the lifespan regarding risk reduction and promoting brain health.”