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 everyĀ outbreak of a novel infectious disease, clinical laboratory tests will be essentialĀ in diagnosis of the disease, in monitoring the progress of an infected patient,Ā 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 andĀ 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 anĀ evaluation of some of the 20 tests offered for sale in this countryĀ to identify antibodies for SARS-CoV-2. A quality control expert inĀ clinical labs called the antibody test analysis deeply flawed in partĀ because of the studyās …
June 22, 2020 Intelligence: Late-Breaking Lab News
As they scrambleĀ to respond to theĀ COVID-19 pandemic,Ā federal officials in multipleĀ agencies are purchasingĀ equipment and supplies fromĀ vendors with dubious credentialsĀ and little operatingĀ history. In recent days, Pro-Publica reported āa fledglingĀ Texas company was paid $7.3Ā mil…
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs
CEO SUMMARY: Every day, national news headlines screamĀ about the shortage of SARS-CoV-2 lab tests needed to manageĀ the COVID-19 pandemic. Recently, national news coverageĀ has begun focusing on concerns about inaccurate or unreliableĀ COVID-19 serology tests. But the story being…
Coronavirus Tests Boost Immunology Labās Volume
CEO SUMMARY: Physicians treating patients with compromisedĀ immune systems who contract the new coronavirus needĀ immunology tests to guide risk-assessment decisions for theseĀ patients. At a Virginia lab that specializes in such testing, specimenĀ volume has tripled since the SAR…
In Michigan, Short Supplies Constrain COVID Test Capacity
CEO SUMMARY: Because of a severe shortage ofĀ supplies, members of Michiganās two hospital laboratoryĀ networks have been stymied in their ability to respond toĀ the pandemic and operate their SARS-CoV-2 analyzersĀ at full capacity. The lack of primers, reagents, specimen-collec…
June 1, 2020 Intelligence: Late-Breaking Lab News
Daily, national newsĀ headlines call attentionĀ to the lack of adequateĀ testing for COVID-19.Ā News reporters question whyĀ clinical labs are unable to meetĀ the demand for SARS-CoV-2Ā tests. One major reason is theĀ lack of adequate supplies labsĀ need to collect specimens,Ā transport them, and per…
Helping Labs with Cash Flow, COVID-19 Response
ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinicalĀ laboratories and anatomic pathology groups in the United States because ofĀ the pandemic. Through the end of last week, The Dark Report estimatesĀ that labs in the U.S. have lost almost $7 billion since the first week of March…
NeoGenomics Spends $37M for Human Longevityās Oncology Division
Once again, Neogenomics, Inc. is using anĀ acquisitionĀ toĀ buildĀ upĀ 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 XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.