March 2020

March 30, 2020 Intelligence: Late-Breaking Lab News

Should consumers be allowed to collect their own specimens for a COVID-19 test? At least five companies announced plans in mid-March to sell COVID-19 tests directly to consumers and have them collect their specimens at home, then return the samples to the the labs doing the testing. This scheme came to a quick end, however, on March 20 when the federal Food and Drug Administration (FDA) issued an alert to […]

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Regulators Acted Slowly as Labs Developed Tests for Coronavirus

Laboratory Compliance / Joseph Burns

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since late last year, researchers for the study have collected 2,500 flu samples from Seattle residents. On Feb. 25, Chu

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In New York, Lab Offers Mobile Virus Sample Collections

Clinical Laboratory / Joseph Burns

CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in the second week of March, demand has increased steadily from one to two calls per day to five to 10 requests daily.

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At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value

TDR Insider / Joseph Burns

This is an excerpt of a 3,210-word article in the March 30, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This intelligence briefing provides a valuable look inside a clinical laboratory that is at ground zero in a city and state that is experiencing the

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Labs in Italy Moved Fast to Develop COVID-19 Tests

Clinical Laboratory / Robert Michel

Part One in a Series ITALY HAS ONE OF THE WORLD’S SEVEREST OUTBREAKS OF COVID-19 INFECTIONS, based on the number of cases and the mortality rate. In response, clinical laboratories there moved quickly to launch laboratory-developed tests and to increase the volume of COVID-19 tests that they could run each day. For Mario Plebani, MD, Professor of Clinical Biochemistry and Clinical Molecular Biology

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Drive-Up COVID-19 Test Site Launched in 3 Days

Clinical Laboratory / Joseph Burns

CEO SUMMARY: After seeing the largest cluster of confirmed coronavirus infections in one location, New York State took emergency measures “to attack the hotspot at its source.” The state opened a drive-through specimen-collection site offering free testing without an appointment or doctor’s order. In partnership with two labs, Gov. Andrew Cuomo ordered the site be operational within three days. At one

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Providers Get Creative as FDA Clears More IVD Firms’ Tests

Clinical Laboratory / Joseph Burns

CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for the disease, the president of the facility used his own personal funds. When two residents of a resort

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This Coronavirus Outbreak Will Change Lab Industry

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: COVID-19 is causing a level of global disruption not seen since the influenza outbreak of 1918. This new infectious disease exposes flaws in the strategies and planning of public health officials and governments in the United States and abroad. In this country, news media quickly recognized that the unavailability of clinical lab tests for COVID-19 was primarily because healthcare

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Lab at the Epicenter of NY’s Coronavirus Pandemic

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

TODAY, THE NOVEL CORONAVIRUS PANDEMIC DOMINATES the daily activities of every clinical laboratory in the United States. The emergence of COVID-19 has triggered unprecedented actions by governments in different nations throughout the world. Within this country, all 50 states reported SARS-CoV-2 infections. But it is New York State that was hit hardest early in this pandemic. Until recent

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March 9, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Coronavirus, more specifically, the novel coronavirus that causes the COVID-19 disease, currently dominates global news. This is the third novel strain of coronavirus to emerge as a threat to human health in the past two decades. Severe acute respiratory syndrome (SARS) was identified in November 2002 and played out by July 2003. China was first

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