CND Life Sciences Achieves FDA Breakthrough Device Designation for Syn-One Test®

CND Life Sciences Receives FDA Breakthrough Device Designation

CND Life Sciences, a pioneering medical technology firm, recently announced that their Syn-One Test® has been awarded the U.S. Food and Drug Administration's (FDA) Breakthrough Device Designation (BDD). This prestigious designation is granted to medical devices that demonstrate significant potential in improving treatment and diagnosis for critical health conditions. The Syn-One Test is specifically designed for the diagnosis of synucleinopathies in patients aged 40 and older who display clinical symptoms indicative of such conditions.

What is the Syn-One Test?

The Syn-One Test has been developed to help diagnose conditions related to synucleinopathies, including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy. These disorders often present complex symptoms, making accurate diagnosis challenging. The Syn-One Test utilizes a minimally invasive procedure where three small skin biopsies are collected from specific anatomical locations. These biopsies help measure the levels of phosphorylated alpha-synuclein (P-SYN) protein, which is a key indicator of these neurodegenerative diseases.

The Significance of Breakthrough Device Designation

The FDA's Breakthrough Devices Program serves to accelerate the development and review process for devices that show promise in addressing serious health issues. For a device to qualify for this designation, it must meet two criteria: evidence of providing more effective treatment or diagnosis for a life-threatening condition and meeting one of four sub-criteria. These include being groundbreaking technology, having no approved alternatives, offering significant advantages over existing options, or being beneficial to patients' interests.

Receiving this designation allows CND Life Sciences to collaborate more closely with the FDA, gaining faster access to essential resources and insights, which can streamline the process towards market availability.

Proven Track Record

Since its introduction as a laboratory developed test (LDT) in late 2019, the Syn-One Test has been ordered for nearly 50,000 patients across the United States in various clinical environments, ranging from community practices to large health systems. Its clinical utility was recently highlighted in a study published in the Journal of the American Medical Association (JAMA), showcasing an impressive sensitivity of 95.5% in identifying abnormal synuclein proteins in patients with these diseases.

Furthermore, research conducted by Yale University indicated that the Syn-One Test altered diagnoses in 52% of evaluated cases, thereby improving medical management in 60% of patients. This evidence points to the test's instrumental role in enhancing diagnostic precision, which is critical for effective patient management.

Looking Ahead

CND Life Sciences remains committed to advancing the usage of the Syn-One Test and improving outcomes for patients facing the threat of neurodegenerative diseases. The company's Chief Medical Officer, Dr. Todd Levine, expressed enthusiasm about the FDA's Breakthrough Device Designation, stating that they look forward to working closely with regulatory authorities as they progress towards future filings.

CND Life Sciences operates a CLIA-certified and CAP-accredited facility in Scottsdale, Arizona, dedicated to developing diagnostic tools for synucleinopathy. Their mission aligns with supporting clinicians in their diagnostic efforts, ensuring patients receive more accurate and timely diagnoses.

Final Thoughts

The Breakthrough Device Designation is a significant achievement for CND Life Sciences, emphasizing the growing recognition of the Syn-One Test's potential impact on diagnosing complex neurodegenerative conditions. With a strong foundation of research and a commitment to innovation, CND Life Sciences is poised to continue leading advancements in the field of neurodiagnostics, helping clinicians effectively address the needs of patients with synucleinopathies.

For further information about CND Life Sciences and their groundbreaking work, please visit their website at cndlifesciences.com.