Policy and Regulation

For 2016 and 2017, Geisinger received at least $6.5M in overpayments from CMS: HHS OIG report

Based on estimates, Geisinger received millions in overpayments for 2016 and 2017 but Geisinger also disagreed with almost all findings outlined in a draft report, OIG said.

March 20, 2023

Cue Health receives FDA emergency use authorization for molecular mpox test

The test demonstrated high accuracy in clinical trials, achieving 100% concordance with the Center for Disease Control and Prevention’s (CDC's) mpox test on the samples tested, Cue Health said.

March 20, 2023

FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis

Specifically, the warning states that reports of adverse events after use of the vaccine under emergency use authorization (EUA) suggest increased risks of myocarditis and pericarditis, particularly from zero through seven days following vaccination.

March 14, 2023

QuidelOrtho nabs FDA de novo authorization for COVID-19 lateral flow immunofluorescent assay

Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay used with the firms Sofia 2 fluorescent immunoassay analyzer.

March 8, 2023

AACC urges HHS to fund interoperability programs, facilitate clinical data sharing

The organization said it is also urging Congress to continue to support the harmonization of clinical laboratory test results. This is crucial to ensuring that the results can be aggregated and compared no matter where or when they’re performed.

March 10, 2023

DermTech obtains melanoma testing coverage for additional 1.9 million people

The skin-based genomics test is a noninvasive way to enhance melanoma detection with a greater than 99% negative predictive value, DermTech said.

March 7, 2023

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Quest launches long-COVID testing panels for consumers

SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests

Duke University researchers discover biomarkers may identify early pancreatic cancer risk

FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay

LumiraDx Q4 revenues drop 65% on lower COVID-19 testing

Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux

Medicare paid $704.2M for drug testing at risk of noncompliance with requirements

In an audit, the Office of Inspector General identified Medicare Part B payments for drug testing services that were at risk for noncompliance with Medicare requirements.

March 1, 2023

AACC provides recommendations for detecting cervical cancer

The guidance aims to update healthcare and laboratory medicine professionals about the latest advancements in this field, and to help them select the most effective cervical cancer detection strategy for their patients, AACC said.

March 6, 2023

Mologic receives FDA EUA for at-home SARS-CoV-2 antigen test, eyes additional respiratory diseases

The development of the rapid antigen test was funded under an $11.8 million contract through the US National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.

February 27, 2023

Lucira Health files for bankruptcy despite receiving FDA green light

The firm is seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic testing products.

February 27, 2023

FDA authorizes Lucira Health OTC test, the first to detect influenza and COVID-19 viruses

In people with symptoms, the Lucira COVID-19 & Flu Test correctly identified 99.3% of negative and 90.1% of positive influenza A samples; 100% of negative and 88.3% of positive COVID-19 samples; and 99.9% of negative influenza B samples, the FDA said.

February 24, 2023

Chembio Diagnostics obtains FDA CLIA waiver for HIV-syphilis testing system

More than 200,000 CLIA-waived point-of-care testing sites in the U.S. can now use the system to detect HIV and syphilis, Richard Eberly, Chembio’s president and CEO, said in a statement.

February 24, 2023

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