TAG:
the clinical laboratory
Where Is the FDA When Labs Need It Most?
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 tha…
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail
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…
Questions Arise as FDA Assesses Serology Tests
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 …
June 22, 2020 Intelligence: Late-Breaking Lab News
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 mil…
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs
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…
Coronavirus Tests Boost Immunology Lab’s Volume
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 SAR…
In Michigan, Short Supplies Constrain COVID Test Capacity
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-collec…
June 1, 2020 Intelligence: Late-Breaking Lab News
Daily, national news headlines call attention to the lack of adequate testing for COVID-19. News reporters question why clinical labs are unable to meet the demand for SARS-CoV-2 tests. One major reason is the lack of adequate supplies labs need to collect specimens, transport them, and per…
Helping Labs with Cash Flow, COVID-19 Response
ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March…
NeoGenomics Spends $37M for Human Longevity’s Oncology Division
Once again, Neogenomics, Inc. is using an acquisition to build up its cancer-testing business. In a deal that closed on Jan. 10, the lab company acquired the Oncology Division of Human Longevity, based in San Diego. Neogenomics said it paid $37 million f…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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