Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics
This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing …
FDA Says 8 of 11 Tests Fail in Serology Test Review Read More »
LET’S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to that disease. Next, let’s recognize another basic fact: clinical lab …
Where Is the FDA When Labs Need It Most? Read More »
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 …
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail Read More »
CEO SUMMARY: On June 4, the FDA released results of an evaluation of some of the 20 tests offered for sale in this country to identify antibodies for SARS-CoV-2. A quality control expert in clinical labs called the antibody test analysis deeply flawed in part because of the study’s design. The FDA evaluated serology assays  using 110 samples from …
Questions Arise as FDA Assesses Serology Tests Read More »
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 …
Health Insurers Push Back On COVID-19 Test Claims Read More »
CEO SUMMARY: Severe shortages of supplies for COVID-19 lab testing caused one lab director in the Midwest to buy additional instruments while also validating five different COVID-19 tests to run on analyzers the lab used before the pandemic hit. While this strategy allowed the lab to bump up the number of COVID-19 tests it can perform daily, ongoing shortages of …
Lab Buys More Instruments as Way to Add Test Volume Read More »
As they scramble to respond to the COVID-19 pandemic, federal officials in multiple agencies are purchasing equipment and supplies from vendors with dubious credentials and little operating history. In recent days, Pro-Publica reported “a fledgling Texas company was paid $7.3 million for test tubes needed in tracking the spread of the coronavirus nationwide. But, instead of the standard vials, Fillakit LLC has supplied plastic tubes made for bottling soda, which state …
June 22, 2020 Intelligence: Late-Breaking Lab News Read More »
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 …
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs Read More »
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”? …
Where Does COVID-19 Take Clinical Labs Next? Read More »
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 …
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs Read More »
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