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The lab firm was accused of billing government payors for unnecessary testing as well as paying illegal compensation to phlebotomy vendors.
A lack of specificity in CMS guidelines combined with increased FDA scrutiny of LDTs could make it more difficult for labs to make changes to existing assays.
With few FDA Emergency Use Authorized serology tests and little independent validation, US labs must choose among 100 assays of unknown quality.
A number of labs and informatics firms are using test data to help guide the response to the virus in a spirit similar to that of initiatives like Lab 2.0.
Total revenues fell to $1.82 billion from $1.89 billion in Q1 2019 as the company saw test volumes drop significantly in the face of the COVID-19 pandemic.
The EUA allows patients to collect samples using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit and will be available in coming weeks.
With clinical labs suffering large drops in volumes as patients stay away from draw centers, remote sampling could provide a way to offer routine testing.
Quest's management, including CEO Steve Rusckowski, will take temporary pay cuts, while rank-and-file employees may be furloughed or have their overtime reduced.
The tool integrates data from more than 20,000 testing locations across the country and is intended to help providers plan their response to the pandemic.
The registry will compile data from LabCorp's SARS-CoV-2 testing with longitudinal medical data to help clinicians better manage and treat the disease.
MicroGen Dx's Texas-based lab is the only commercial laboratory in the US offering sputum testing for SARS-CoV-2.
This week Quest Diagnostics said it saw declines of more than 40 percent while other industry observers reported drops of as much as 90 percent for some labs.
The firm believes that its molecular assay for the laboratory will help ease some of the supply chain issues hampering test rollout during the pandemic.
In a letter, the Trump administration has asked hospitals to report their SARS-CoV-2 testing data every day to HHS.
If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.
The company has issued a call for the 2,500 independent MDx labs across the US to join together in an effort to double SARS-CoV-2 testing capacity.
The firms are developing a testing system that involves drawing fingertip blood and doing routine testing in Babson's CLIA-certified laboratory.
The lab is increasing its capacity to 1,000 tests each day with plans to reach 28,000 tests per week in the next few weeks.
The company has said it expects to be able to perform roughly 10,000 tests a day by the end of this week and roughly 20,000 tests per day by the end of March.
ACLA President Julie Khani emphasized that commercial labs have been performing SARS-CoV-2 testing without confirmation of payment.