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Search Results for: COVID-19

New York Firm to Build CLIA Labs in Shipping Containers

Clinical Laboratory Trends / By Robert Michel

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 gold rush has encouraged companies such as Amazon and Alphabet/Google to build their own clinical labs. Now …

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September 14, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Alphabet, Inc., the parent of Google, is expanding its COVID-19 testing activities. In recent months, Verily Life Sciences—a division of Alphabet devoted to research into life sciences—organized a clinical laboratory for COVID-19 testing. It obtained CLIA certification and is licensed with the State of California. In a blog, Verily’s Head of Pathology, Deb Hanks, MD, wrote that the lab had “verified the performance of the SARS-CoV-2 RT-PCR test …

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FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

TDR Insider / By Robert Michel

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts …

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

Laboratory Compliance / By Robert Michel

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said that labs “are not required” to obtain an FDA emergency use authorization or FDA clearance of LDTs. Clinical labs welcomed …

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Specimen Volume Returns at Dallas-based ProPath

Anatomic Pathology / By Robert Michel

CEO SUMMARY: Like other physician specialties, anatomic pathology saw a dramatic collapse in the number of daily procedures with a corresponding decline in cash flow as the COVID-19 pandemic hit with full force in March, April, and May. The good news is that the daily volume of tissue referrals is increasing steadily as patients decide it will be safe to …

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Quest Reports 46% Decline in New Cancer Diagnoses in March

Anatomic Pathology / By Robert Michel

ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemic and shelter-in-place directives—fewer patients visited physicians’ offices, meaning many cases of cancer and other conditions could go undiagnosed. In new …

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Wisconsin Lab Network Feeds Valuable Data to State Health Lab

Clinical Laboratory / By Robert Michel

CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and capacity. Founded 20 years ago, the network is a public-private partnership that allows participating …

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Thermo–Qaigen Merger Stopped, More IVDs Report Q2 Earnings

In Vitro Diagnostics / By Robert Michel

EACH TIME A MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANY reports its quarterly earnings, clinical lab executives and pathologists gain useful new perspectives as to how the COVID-19 pandemic is fueling demand for IVD instruments, tests, and lab consumables. In this round-up of the most recent quarterly earnings reports, we provide details about Thermo Fisher Scientific, Agilent Technologies, bioMerieux, Bio-Rad, and Sysmex Corporation. IVD …

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CMS Publishes Proposed 2021 Medicare Physician Fee Schedule

Clinical Laboratory Trends / By Robert Michel

MEDICARE’S PROPOSED PHYSICIAN FEE SCHEDULE (PFS) rule was announced on Aug. 4, 2020. The rule had one positive development for clinical laboratories and hospital laboratory outreach programs and a negative development for anatomic pathologists. Clinical laboratories and hospital outreach labs will welcome the news that the proposed 2021 rule would delay the next Clinical Laboratory Fee Schedule (CLFS) reporting period by an additional year This …

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Proposed Medicare 2021 PFS Cuts Pathology Fees by 9%

Anatomic Pathology / By Robert Michel

IF THE PROPOSED MEDICARE 2012 PHYSICIAN FEE SCHEDULE (PFS) RULE—published by the Centers for Medicare and Medicaid Services (CMS) on Aug. 4—takes effect as currently written, pathology professional fees will be cut by 9%, effective Jan. 1, 2021. This was not welcome news for the anatomic pathology profession. The proposed 9% cut to Medicare payment for pathology services is the result of CMS deciding …

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