The test can now be used to identify triple-negative breast cancer patients who are likely to benefit from the immunotherapy Tecentriq plus chemotherapy.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
Though the firm saw lower overall revenue, it increased its fourth quarter and full-year product and services revenue by 12 percent and 16 percent respectively.
The researchers said that their proof-of-concept microfluidic platform is 1,000 times more sensitive than a traditional ELISA.
Epigenomics terminated its collaboration with China's BioChain for the licensing of the septin9 marker and exclusive Chinese distribution rights for Epi proColon.
Researchers at RMIT University have described collecting bronchial brushings as part of a molecular approach that may enable diagnosing lung cancer patients and guiding therapies.
The firm will expand on its MSI assay for use in immunotherapy while developing liquid biopsy assays to monitor patients post therapy and for recurrence.
The test is designed to determine which early-stage, estrogen receptor-positive breast cancer patients are likely to benefit from extended endocrine therapy.
The device, called the MasSpec Pen, was developed by University of Texas researchers to help more quickly and accurately assess margins during cancer surgery.
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
The PhosphorusOne test uses next-generation sequencing to analyze 375 genes covering 170 inherited conditions and 175 different drug reactions.
The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.
The company also reported higher operating costs due to an expansion of its US sales force, as well as its European commercial and laboratory staff.
The firm plans to submit its Idylla MSI test for 510(k) clearance from the US Food and Drug Administration after receiving CE-IVD approval this morning.
At the AGBT meeting last night, Johns Hopkins researcher Joshua Cohen said that the partners are looking to recruit 50,000 healthy individuals for the study.
Data being presented at the upcoming AACR meeting show that Guardant's liquid biopsy test provided more accurate and rapid mutation detection than tissue genotyping.
The assay monitors mutations across a patient's genome and matches them to mutations found in a patient's resected tumor and in DNA in the bloodstream.
The firm said that its cell-free DNA assay has shown a high positive predictive value in preliminary clinical studies involving stage IV colorectal cancer patients.
The test uses qPCR to measure the methylation level of three bladder cancer-specific biomarkers in patient urine samples.
Biocept will use its liquid biopsy assay to test cerebrospinal fluids of patients diagnosed with certain cancers and then compare results to standard methods.