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A SNP in the pan-SARS E gene has not affected patient results, but has raised concerns about the overall unavailability of commercial primer and probe information.

Lab firms are acquiring equipment and implementing approaches like pooled testing, but it remains unclear if this will be enough to meet a fall surge.

The company said the method will boost SARS-CoV-2 test capacity by 35,000 tests per day and bring turnaround times to one day for priority patients.

The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.

The inability to get COVID-19 test kits and the reagents to run the tests was especially problematic as 58 percent of labs cited such an issue.

The company reported $2.77 billion in revenues on the quarter, down from $2.88 billion in Q2 2019 but above the consensus Wall Street estimate of $2.5 billion.

The FDA reissued the EUA after analyzing LabCorp data that showed the test could detect SARS-CoV-2 in a general asymptomatic population.

The coming uptick in flu and other respiratory viruses will likely complicate the diagnosis of COVID-19 even as labs continue to struggle with capacity.

While Q2 revenues were down to $1.83 billion, the results represented a rebound from Q1 as the company saw expanded routine and SARS-CoV-2 testing.

The letter calls for expanded access to COVID-testing for everyone regardless of insurance coverage or reason for receiving the test.

The facility, which plans to launch an MRM assay for HER2 as its initial test, is one of the few clinical labs to focus primarily on targeted protein mass spec.  

Even as the broader lab industry struggles to meet SARS-CoV-2 testing needs, many labs focused on nursing homes are unable to benefit from the demand.

Last month the agency said it had begun examining Medicare claims data to look for potential fraud in ordering of SARS-CoV-2 testing and related tests.

The firms supporting the new lab include Thermo Fisher Scientific, Canon Medical, and Siemens Healthineers, all of which will contribute their know-how and technologies to the effort.

While down 6 percent year-over-year, the estimate beats analysts estimates of $1.5 billion and reflects a stronger-than-expected rebound in test volumes.

The organizations requested a list of the names and contact information for individuals in each state overseeing the supply chain for testing supplies and PPE.

Sciex has discontinued the Topaz platform three years after its launch while Thermo Fisher aims to drive adoption of its Cascadion following a recent US launch.

High-throughput sample prep is becoming critical to COVID-19 testing scale-up, but some labs are experiencing shortages at this stage in the testing workflow.

Issued last week, the guidance said insurers were not required to reimburse such testing, which could impact coverage in schools, workplaces, and other settings.

With students and faculty scheduled to return in a few months, institutions are reaching out to secure testing to help keep the virus in check on campus.

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