The FDA has granted the OncobiotaLUNG assay a breakthrough device designation for the early detection of lung cancer.
The FDA has provided the OncobiotaLUNG assay a breakthrough device designation, according to the device maker, Micronoma.1
The OncobiotaLUNG assay is microbiome-driven liquid biopsy platform used for the early detection of lung cancer. The device categorizes lung nodule samples into those that are considered high or low-risk for malignancy based off of a blood draw from the patient. According to the new designation, the company is expecting prioritized reviews from the agency regarding upcoming trials further analyzing the effectiveness of the assay.
Read more at Targeted Oncology