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Search Results for: COVID-19

IVD Firms Report Boom in Sales of COVID-19 Instruments, Tests

In Vitro Diagnostics / By Robert Michel

Because of the COVID-19 pandemic, second quarter earnings reports were a good news/bad news situation for most of the nation’s major in vitro diagnostic (IVD) companies. The good news was that demand for COVID-19 tests meant increased sales and revenues for IVD firms selling those products. But the collapse in routine lab testing that happened in March, April, May, and June was bad news …

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Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

TDR Insider / By Robert Michel

This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number …

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COVID-19 Pooled Testing: Good for Labs? Not IVDs?

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplies, while conserving standard non-pooled tests for symptomatic patients. But pooled testing also could cut into test manufacturers’ revenue, …

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Officials Differ on Value of COVID-19 Pooled Testing

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare and Medicaid Services say pooled testing is not diagnostic and so any lab can do these tests. But CMS …

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Why Local Labs Deserve More COVID-19 Supplies

Laboratory Equipment / By Robert Michel

CEO SUMMARY: As government officials and IVD firms divert the lion’s share of COVID-19 tests to a handful of billion-dollar labs, in thousands of hospitals across the nation COVID-19 patients languish days longer before discharge because their hospital lab must send COVID-19 tests to outside labs and wait up to seven days for results. Yet, those same hospital labs have …

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COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail

Clinical Laboratory / By Robert Michel

CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from the market. Also, the FDA says 45 …

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Health Insurers Push Back On COVID-19 Test Claims

Laboratory Billing / By Joseph Burns

CEO SUMMARY: Under new federal laws, health insurers are required to pay for testing for the novel coronavirus without cost-sharing, prior authorization, or medical management limits, but insurers are questioning these COVID-19 lab test bills and denying many of the claims, a healthcare attorney said. Payers are challenging the medical necessity of COVID-19 tests, such as for patients needing surgery and …

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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

TDR Insider / By Robert Michel

This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun …

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Where Does COVID-19 Take Clinical Labs Next?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

It is easy to say that the current COVID-19 pandemic is a global event without precedent in human history. After all, what other event has caused airline travel to drop by 95%, ended all professional and amateur sports events worldwide, shuttered Broadway theaters and movie cinemas, closed all non-essential businesses, and required nearly all citizens to “shelter in place”? …

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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being missed by the national news media is the steady deterioration of the finances of the clinical laboratory organizations that are …

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