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laboratory services
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
Congress Passes Bill to Ban Surprise Medical Bills
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
Starting Jan. 1, 2022, out-of-network clinical laboratories may no longer be allowed to bill patients for lab tests performed in certain settings under a law both houses of Congress passed on Dec. 21. The COVID relief bill includes a ban on unexpected m…
Palmetto GBA Tells Consultant to Take Down Test Price Data
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
CEO SUMMARY: Lawyers for Medicare contractor Palmetto GBA sent a cease and desist letter in September to a respected lab consultant, telling him to delete from his health policy blog a document containing Medicare genetic test price and coding data. In the letter, Quinn was directed…
New Clinical Lab Opens on March 23 and Prospers
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
CEO SUMMARY: Timing is everything when launching a new clinical laboratory business. The March 23 grand opening of Incyte Pathology’s clinical lab came in the midst of the collapse of daily routine specimen referrals. But once the lab was operational, Incyte had the capability, the …
Understanding COVID-19’s Changes to Lab Industry
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…
New York Firm to Build CLIA Labs in Shipping Containers
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: In many respects, the COVID-19 pandemic is like a gold rush for entrepreneurs. Federal and state governments, colleges, employers, school districts, and other entities need COVID-19 tests and tens of billions of dollars are available to pay for such tests. This modern gol…
COVID-19 Changes Lab and Pathology Profession
By R. Lewis Dark | From the Volume XXVII, No. 11 – August 3, 2020 Issue
WE ARE ENTERING THE SEVENTH MONTH OF THE SARS-COV-2 OUTBREAK and some public health authorities predict that new cases of COVID-19 will continue through the fall and into 2021. If true, this will not be auspicious for the nation’s clinical laboratories and anatomic pathology groups. The curren…
Coronavirus Tests Boost Immunology Lab’s Volume
By Joseph Burns | From the Volume XXVII No. 8 – June 1, 2020 Issue
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
By Joseph Burns | From the Volume XXVII No. 8 – June 1, 2020 Issue
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…
Lab Directors Develop Plans for Return of Routine Hospital Care
By Joseph Burns | From the Volume XXVII No. 8 – June 1, 2020 Issue
CLINICAL LABORATORY DIRECTORS IN MICHIGAN are developing plans to test patients who will return when hospitals reopen for routine care. Included in those plans are strategies to do testing for the novel coronavirus on patients who will return for everyday care and elective procedures, said Bart…
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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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