Roche’s Basic medicine leads the latest group of breakthrough designations from the FDA, securing regulatory privileges for a test designed to detect circulating tumor DNA (ctDNA) in plasma.
The FDA has achieved breakthrough status for testing in the detection of molecular residual disease (MRD) in cancer at an early stage after curative treatment. With some therapies removing tumors but leaving residual disease, a patient’s MRD status can indicate whether further treatment is needed and help assess the risk of relapse.
Foundation Medicine developed the test, FoundationOne Tracker, with Natera. Businesses associates in 2019 to use components of Natera’s Signatera platform to develop monitoring assays for use by biopharmaceutical and clinical customers who order the FoundationOne CDx pan-tumor liquid biopsy and then transitioned to make the test available for research purposes last year.
FoundationOne Tracker is one of two liquid biopsies in the FDA’s latest batch of breakthrough designations. The agency too has obtained regulatory status has a Cancer Genetics Datar blood test to detect prostate cancer at an early stage. Datar Cancer Genetics has already received breakthrough status from the FDA for its early-stage breast cancer screening test.
The latest group of breakthrough designations from the FDA also includes two treatments for epilepsy. NeuroSigma earned breakthrough status for its Monarch eTNS system for add-on use to reduce seizure frequency in people 18 years of age or older. It is intended to treat partial-onset seizures that do not respond to two or more antiepileptic drugs.
NeuroSigma’s Monarch eTNS provides external trigeminal nerve stimulation. The device, which is already licensed for use in the treatment of pediatric ADHD, reduces the frequency seizures in patients with drug-resistant epilepsy in a small clinical trial.
Precision picked up the other breakthrough epilepsy-related device has been cleared by the FDA, securing the status of its EASEE brain stimulator. The device consists of electrodes that are positioned on the skull bone under the scalp. By delivering current to a specific area of the brain, EASEE is designed to inhibit epileptic seizures. Precisis markets the device as a simpler, less invasive alternative to vagus nerve and deep brain stimulation.
The FDA also recently granted groundbreaking designations to cardiovascular disease devices. fast medical obtained regulatory privileges for its Comaneci embolization assist device in the treatment of cerebral vasospasm following a hemorrhagic stroke. Vasospasm describes the narrowing of the arteries. Comaneci is designed to allow doctors to temporarily dilate blood vessels.
Cardiosens received the other recent nod to cardiovascular disease for an algorithm to identify patients at risk of decompensated heart failure. The algorithm analyzes data collected by the CardioTag device to noninvasively assess pulmonary capillary pressure (PCWP). Cardiosense’s breakthrough status comes months after Secure VolMetrix the same privileges for its noninvasive approach to PCWP, a measure that indicates whether a patient has heart failure currently requiring invasive catheterization.
Therapeutic received breakthrough status for its OsteoAdapt SP Spinal Fusion implant in posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis. The implant is part of Theradaptive’s offering to improve the safety of existing devices for spinal fusion, orthopedic repair or craniomaxillofacial repair, while reducing revision procedures, through the use of regenerative implants.
FDA granted breakthrough status for Bonalive Biomaterials‘ Orthopedic granules. The pellets, made of a bioactive glass, are intended for use as a bone graft substitute that potentially protects against microbial colonization.
The agency too awarded breakthrough designation for Non-invasiveit’s LIVOx Central Venous Oxygenation Monitor for use in adults at risk for septic shock. LIVOx is a non-invasive device that monitors central venous oxygen saturation, an indicator of septic shock, in an attempt to aid early treatment of the life-threatening condition.
Ultimately, DynamiCare Health received the Breakthrough Device designation for digital therapeutics to treat smoking disorders complicating pregnancy and childbirth. The digital treatment is based on a motivational incentives approach in which patients earn financial incentives for abstaining from smoking. In addition to a smartphone app, the device consists of a connected respiratory carbon monoxide monitor, saliva nicotine tests and a rechargeable debit card.