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Williams v Quest/Athena struck a nerve with the genetic testing community by probing what the standard of care is and ought to be for variant classification.  

SARS-CoV-2 has accelerated pre-existing trends towards direct-to-consumer testing, which has necessitated new LIS capabilities, particularly for smaller labs.

The RT-PCR-based test was first authorized in March for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.

The FDA recommended following test instructions and noted that processing multiple specimens in batches could create challenges for proper intubation time.

The agreement will initially focus on making available assays developed and validated by LabCorp's Covance business, with the first assays targeting oncology.

The ratio of IL-6 to IL-10 biomarkers might give clinicians insight into how severe the inflammatory response to SARS-CoV-2 could be in certain patients.

Total revenues were $3.90 billion, up from $2.93 billion in the third quarter of 2019, and above the consensus Wall Street estimate of $3.63 billion.

Revenues were $2.79 billion for Q3, up from $1.96 billion in the third quarter last year and beating the consensus Wall Street estimate of $2.73 billion.

CMS will now only reimburse labs performing high-throughput COVID-19 testing at the highest payment rate if they complete testing within two days of specimen collection.

As government lab spending grows, the Medicare contractor has barred access to a coding and pricing file obtained via FOIA claiming it holds business secrets.

Reimbursement and liability issues will be impacted by FDA's decision, while LDT users could find it difficult to assess the quality of the new tests.

Laboratories are continuing to experience supply chain interruptions and are facing significant staffing shortages, the report found.

The owner of Specialty Drug Testing, a Monroe, Louisiana-based laboratory, appeared in United States District Court accused of violating the Anti-Kickback Statute.

The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.

The organizations have also requested a meeting with the White House Pandemic Task Force to discuss issues surrounding supply allocation for COVID-19 testing.

The federal government alleged Phamatech paid a clinic to refer it drug testing business, violating the federal Anti-Kickback Statute and the False Claims Act.

As labs without prior molecular testing or high-volume testing experience bring SARS-CoV-2 testing online, some are finding that an LIS upgrade is in order.

Under the multiyear agreement, LabCorp will provide lab management, phlebotomy, logistics services, and reference testing for the Alabama-based health provider.

Responses from more than 200 healthcare systems show familiar concerns around lowering testing costs but some optimism regarding the outreach space.

The effort is part of a pilot program exploring what role drones could play in responding to the pandemic and healthcare delivery more generally.