FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer's disease and bladder cancer.
Quanterix received the breakthrough designation for the Alzheimer's test. The status covers a blood test designed to measure the concentration of phospho-Tau 181 using the Quanterix HD-X immunoassay system. With researchers finding elevated levels of the Tau protein in patients with neurodegenerative diseases, Quanterix sees the semiquantitative immunoassay as a way to aid the diagnostic evaluation of people who present with cognitive impairment.
The product is part of an effort to support the transformation of the Alzheimer's market, which has recently been given new life by the accelerated though controversial approval of the drug Aduhelm to open up opportunities for the diagnostic industry.
"It's about blood-based biomarkers fast becoming the gold standard, surrogates for traditional tau and Abeta PET imaging. So, transforming drug discovery in neuro primarily from spinal taps and imaging into blood-based is a key opportunity area that we're very focused on and making a lot of progress within," Quanterix CEO Kevin Hrusovsky told investors in August.
Elsewhere in liquid-based tests, Nonagen Bioscience received breakthrough device designation for its Oncuria non-invasive bladder cancer test. Oncuria is a multiplex immunoassay that measures levels of 10 protein biomarkers. By combining the levels in a weighted algorithm, Nonagen aims to predict how a patient will respond to Bacillus Calmette-Guerin, a therapy that can be highly effective but fails more than 50% of people, and thereby avoid the administration of ineffective treatments.
FDA also awarded breakthrough status to Selux Diagnostics' rapid antimicrobial susceptibility test. The investigational test analyzes blood and other sterile body fluids to determine which of up to 40 medicines may be effective in patients with drug-resistant infections. Selux said it can take four days or more to determine the susceptibility of a patient to antimicrobials using current methods. Cutting that time could lead to faster targeted treatment of infections.
Separate from the liquid-based test space, Nyxoah received breakthrough status for a bilateral hypoglossal nerve stimulation system intended for use in patients with severe obstructive sleep apnea and complete concentric collapse of the soft palate. The award follows the release of top-line data from a clinical trial that met its primary safety and performance endpoints.
FDA also granted breakthrough designation to Novian Health's laser therapy for breast cancer. The minimally invasive system is designed to destroy tumors using laser ablation, enabling breast cancer patients to get treated without surgery. Novian, which already sells the system for the treatment of benign breast tumors, plans to start a pivotal clinical trial next year.
Finally, Amber Implants secured breakthrough status for its treatment of vertebral fractures. The VCFix spinal system features a 3D-printed perforated structure and is intended to treat fractures without the use of bone cement. Amber Implants plans to start a first-in-human clinical trial early next year.
