TAG:
pathology groups
FDA Says 8 of 11 Tests Fail in Serology Test Review
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,…
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…
Companies Saw Big Drop in Lab Revenue from Mid-March
This is an excerpt of a 2,083-word article in the April 20, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine c…
From Mid-March, Labs Saw Big Drop in Revenue
CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical labs and pathology groups were hit with a substantial decline in revenue. One of t…
Labs May Qualify for Relief Under New Federal Laws
CEO SUMMARY: After routine testing and specimen volume declined last month, so too did the associated revenue. In response, clinical laboratories and anatomic pathology groups want to bolster their finances quickly or risk incurring more financial damage to already-fragile…
Is Health Price Transparency at Its Tipping Point?
Is it a coincidence that a number of uninsured consumers filed separate lawsuits in federal courts against Laboratory Corporation of America and Quest Diagnostics—alleging, in both cases, that they were overcharged for clinical…
Pathology Groups Should Plan to Use Digital Pathology
WHEN AN ANATOMIC PATHOLOGY GROUP CONSIDERS IMPLEMENTING digital pathology and whole-slide imaging (WSI) for primary diagnosis, it must identify and understand a range of challenges and opportunities. “Every pathology group should start by considering how it will use the related technologies of a…
Labs Face New Challenges in New Year, New Decade
TYPICALLY, PEOPLE CELEBRATE THE ARRIVAL OF A NEW YEAR and a new decade with optimism. That should be just as true for clinical lab managers and pathologists. After all, medical laboratory testing is fundamental to how physicians diagnose disease, select the most appropriate therapies, and monitor the…
Lab Benefit Managers Want to Help Health Plans
CEO SUMMARY: Laboratory benefit management companies that offer a range of services to health insurers are gaining influence over clinical lab testing in important ways. On behalf of health insurers, LBMs will select labs for a payer’s network, then manage that network. They also manage…
CURRENT ISSUE
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.
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