Insightec, discovered breakthrough NSCLC brain mets study and FDA approval for two investigational device exemptions (IDE) for the Exablate Neuro system.
Liquid biopsy is a new way of treatment for noninvasive cancer subtyping, treatment selection, monitoring residual disease, early detection of treatment responders against non-responders, and assessment of tumor progression against pseudoprogression.
Liquid biopsy has limited success in brain tumors compared to other cancers due to the barrier of blood brain which limits the signal detection in the bloodstream.
The current advance in neuro-oncology is that it uses low-intensity focused ultrasound (LIFU) with microbubbles to open up the blood brain barrier(BBB) and this LIFU shows to be the paradigm shift in the treatment of patients with brain tumors. Morover, early studies have shown that low-intensity focused ultrasound (LIFU) can easily increase the permeability of the blood brain barrier and thus allowing passage of region-specific biomarkers to enable noninvasive liquid biopsy in brain tumors.
Among the two FDA approvals, one is for primary non-small cell lung cancer (NSCLC) which can spread to the brain in conjunction with standard-of-care Keytruda, and the other one is for increased efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer.
LIMITLESS study (NSCLC) is introduced to provide clinical data of patients using noninvasive, low-intensity focused ultrasound accompanied with systemic immunotherapy for the treatment of patients with brain metastases from lung cancer.
