Although courts have yet to weigh in on the issue, guidelines from the US Equal Employment Opportunity Commission and other regulatory agencies indicate that employers may implement vaccine passports … [Read more...]
Compliance Perspectives
The 5 Things to Do When Implementing a Vaccine Passport Policy at Your Lab
September 6, 2021
Like many labs and other health providers, you might have been undecided about whether to mandate that your employees get the COVID-19 vaccine. However, now that the FDA has fully approved a … [Read more...]
FDA Watch
Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
September 6, 2021
Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive … [Read more...]
Testing Trends
FDA Regulation of COVID-19 Testing Enters a New Phase
August 26, 2021
The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers … [Read more...]
Clinical Guidelines
AHA Calls for Individualized Approach to Pediatric Cardiovascular Genetic Testing
August 23, 2021
Genetic testing of children can play a key role in determining a child’s risk of developing heritable cardiovascular disease. But testing should be limited to children with a high likelihood of … [Read more...]
CLINICAL GUIDELINES
CDC Updates Guidelines on Laboratory Testing for Sexually Transmitted Infections
August 2, 2021
On July 22, the US Centers for Disease Control and Prevention (CDC) revised its guidelines for the diagnosis and treatment of sexually transmitted infections (STI), including with regard to how to … [Read more...]
FDA Watch
First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
July 11, 2021
The U.S. Food and Drug Administration (FDA) continues to step outside its traditional comfort zone in response to COVID-19 pandemic pressures. Among the most recent agency firsts is best seen as part … [Read more...]
FDA Watch
Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority
June 14, 2021
When history is written, acceleration of the longstanding effort to eliminate the authority of the U.S. Food and Drug Administration (FDA) to regulate Laboratory Developed Tests (LDTs) may be … [Read more...]
Increasing Revenue
New Colorectal Cancer Screening Guidelines Are a Windfall for Exact Sciences, Cologuard
June 8, 2021
If you held stock in Exact Sciences on May 17, chances are you went to bed happy on May 18. It was on May 18 that a U.S. government taskforce officially announced a change in its guidelines for … [Read more...]
LDTs
AACC Guidelines Caution Against Using Serology Tests to Determine COVID-19 Vaccine Efficacy
May 22, 2021
Although SARS-CoV-2 serology tests have yet to live up to the hype, they are still expected to play a crucial role in coronavirus infection control efforts going forward. In addition to accuracy … [Read more...]
