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July 13, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

On July 9, eight national laboratory associations sent a letter to Vice President Mike Pence to request that the White House Coronavirus Task Force take action to resolve major obstacles that constrain the ability of their member laboratories to perform molecular and serological tests for COVID-19. Specifically, the lab associations want action and resolution on supply chain issues. The letter noted that “At times, our members have even received faulty …

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Volume XXVII No. 9 – June 22, 2020

THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.

FDA Says 8 of 11 Tests Fail in Serology Test Review

TDR Insider / By Robert Michel

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 …

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Where Is the FDA When Labs Need It Most?

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

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 …

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Questions Arise as FDA Assesses Serology Tests

Clinical Laboratory / By Joseph Burns

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 …

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Lab Buys More Instruments as Way to Add Test Volume

Laboratory Equipment / By Joseph Burns

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 …

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June 22, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

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 …

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Volume XXVII No. 8 – June 1, 2020

THE DARK REPORT brings news that the national media has overlooked: Lab revenues, cut precipitously during the coronavirus pandemic, will leave many labs without the resources to continue operation in the near future. As calculated by THE DARK REPORT, the nation’s clinical lab industry had lost $6.8 billion in revenue by week 12 of the crisis. Also reported is that in many cases, the culprit is a frustrating lack of supplies that would allow labs to replace lost routine testing with new COVID-19 testing.

Coronavirus Tests Boost Immunology Lab’s Volume

Clinical Laboratory / By Joseph Burns

CEO SUMMARY: Physicians treating patients with compromised immune systems who contract the new coronavirus need immunology tests to guide risk-assessment decisions for these patients. At a Virginia lab that specializes in such testing, specimen volume has tripled since the SARS-CoV-2 pandemic began. The lab does immunology testing for patients needing transplants, as well as for patients who have AIDS, cancer, diabetes, heart …

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In Michigan, Short Supplies Constrain COVID Test Capacity

Clinical Laboratory / By Joseph Burns

CEO SUMMARY: Because of a severe shortage of supplies, members of Michigan’s two hospital laboratory networks have been stymied in their ability to respond to the pandemic and operate their SARS-CoV-2 analyzers at full capacity. The lack of primers, reagents, specimen-collection swabs, test kits, and viral transport media resulted from directives federal officials imposed in the supply chain in favor of …

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