Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

Current Issue of LIR

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Reimbursement

Feds Say Insurers Not Required to Pay for Employer Return to Work COVID-19 Testing

Since the public health emergency began, the US government has taken the position that insurers shouldn’t be allowed to make consumers pay for COVID-19 lab tests. But now comes news that insurers will … [Read more...]

M&A Report

Thermo Fisher Acquisition of Qiagen Remains on Track

COVID-19 continues to cast a pall on strategic M&A activity in the diagnostics space with the key players monitoring events before making their moves. However, there are still a few smaller deals … [Read more...]

Diagnostics Deals

Pandemic Infuses New Urgency Into Effort to Develop Genomics-Based Early PTSD Detection Diagnostics

In addition to death and dislocation, the global COVID-19 pandemic is likely to spawn a crisis in mental health, including a spike in post-traumatic syndrome disorder (PTSD) cases. With this in mind, … [Read more...]

FDA Watch

Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests

It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to … [Read more...]

DX Earnings Report

Strong Q1 Earnings Belie the True Financial Devastation of COVID-19

The bad news is that COVID-19 is very, very bad for business; the good news—sort  of—is that the pandemic had just the last few weeks of March to wreak havoc on 2020 Q1 earnings reports. And even that … [Read more...]

Market Trends

New Survey Documents Extent of Lab Business Damage Inflicted by COVID-19

The fact that the lab business is taking a beating as a result of the COVID-19 pandemic is hardly news. But a recent survey sheds important new light on the extent of the devastation. The Kalorama … [Read more...]

Emerging Markets

After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing

Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance … [Read more...]

COVID Restrictions Ease

Top 10 questions an employer should ask before returning employees to work

By Mike O’Brien bio As various states and municipalities across the country lift shutdowns and begin easing COVID restrictions, employers are faced with complex questions about safely bringing … [Read more...]


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