DISCERN Alzheimer’s Diagnostic Test Launches in Dallas/Fort Worth

Texas selected because of high need and 'proactive strategies' to combat the disease

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by Mary Chapman |

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Residents in the Dallas/Fort Worth area of Texas will be among the first to have access to a minimally invasive diagnostic test for Alzheimer’s disease.

The DISCERN test, by SYNAPS Dx (SDx), will be commercially launched in Texas because of the state’s relatively high number of people diagnosed with Alzheimer’s — approximately 390,000 — and its focus on combating the disease.

“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,” Frank Amato, president and CEO of SDx, said in a press release.

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DISCERN is touted as the first easily administered test that can accurately identify Alzheimer’s, even at the beginning stages, and distinguish it from other forms of dementia. Early and definitive diagnoses enable healthcare providers to create care plans earlier, and allow patients an opportunity to better prepare for the future.

Due to the disorder’s complexity, no simple test exists to diagnose Alzheimer’s. Therefore, diagnoses are made by evaluating relevant medical history, signs and symptoms, lab tests, and brain imaging.

DISCERN evaluates factors directly related to the formation of synaptic connections in the brain. Synaptic loss is an established indicator of cognitive decline, as synapses are critical for cognitive function and memory as they are the junctions between two nerve cells that allow these cells to communicate.

The test also looks for regulators of amyloid plaque and tau formation, biomarkers that are unique to Alzheimer’s.

It requires a small skin sample, which is then sent to a lab for testing. Results take between six and 12 weeks.

“DISCERN has received Breakthrough Designation by the FDA and is the first [Alzheimer’s] test of its kind to earn Proprietary Laboratory Analyses (PLA) codes 206U and 207U and has been reimbursed for people insured with Medicare Fee-for-Service,” Amato said. “Currently, there are no FDA-approved tests that are as highly accurate as DISCERN for supporting clinicians’ diagnoses of [Alzheimer’s disease], and we look forward to filling this void, starting with the state of Texas.”

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“We already have significant interest throughout the Dallas medical community for DISCERN, which has demonstrated >95% specificity and sensitivity in identifying [Alzheimer’s] through long-duration, autopsy-validated, blinded clinical trials,” he added.

Under its Texas State Plan for Alzheimer’s Disease 2019–2023, the state is implementing strategies to address the disease. Those plans include improving early detection and treatments, and reducing disease risks. They also include education, caregiver support, advancing research, and collecting and evaluating other efforts to prevent and treat Alzheimer’s and other dementias.

“Texans are truly fortunate to be the first in the region for national commercialization of this amazing, highly accurate diagnostic test,” said Michael Gorton, CEO, Recuro Health, who was recently appointed to the SDx advisory council. “Thanks to the innovative and entrepreneurial spirit of the leadership team, more Texans will benefit from this important healthcare breakthrough.”