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The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
A four-year, $5.5 million program will assess whether circulating cell-free DNA testing can improve diagnosis and outcomes for a type of EBV-associated cancer.
The firm posted $29.7 million in revenues, up about 15 percent from $25.8 million in Q4 2018 and slightly above the analysts' average estimate of $29.5 million.
Natera discussed its cancer and transplant rejection testing businesses, while Exact Sciences explained how it will benefit from its Genomic Health acquisition.
While NanoString will commercialize its nCounter for research use applications, Veracyte will move its current assays onto the platform to reach a global audience.
The immune sequencing firm is working on kit-ifying its two existing tests, as well as developing a second clinical test and expanding the label for clonoSeq.
Despite initial promise, NGS-based MRD detection has not been broadly adopted, but improvements in technology and more clinical utility data may change that.
The firm's nanotechnology-enabled, AI-based, machine learning tool identifies biomarkers in blood samples and produces results in 10 to 30 seconds.
The researchers have prospectively validated a disposable cartridge-based microfluidic assay by obtaining results using fine-needle aspirates in 40 patients.
The group now plans to run the 32-gene panel in clinical trials to demonstrate its utility and make the case for offering it within Canada's healthcare system.