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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.
Roche will have non-exclusive access to SpeeDx's existing tests and technology to enable expansion of diagnostic products for antibiotic resistance in STIs.
The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.
Some parts of Europe turned to serology testing early to try to get a handle on the pandemic but had to quickly pull back after those tests performed abysmally.
More than 70 percent of labs surveyed experienced supply chain interruptions, forcing them to validate three or more diagnostic testing methods.
Roche said the acquisition is expected to advance development of its nanopore sequencer by providing access to Stratos' Sequencing by Expansion chemistry.
A UK official said that the government is working with other companies on developing tests with rapid turnaround times and noted a test from UK firm OptiGene.
The reimbursement rates for the most commonly performed SARS-CoV-2 serologic tests are $42.13 and $45.23, depending on the billing code used.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
Only 2.5 percent of Americans have been tested for COVID-19, even as industry scrambles to increase testing capacity and a second wave of cases may hit in the fall.