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Roche's $1.8B GenMark deal brings a key testing capability for Covid-19 and beyond

Roche's $1.8B GenMark deal brings a key testing capability for Covid-19 and beyond
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Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020 | Mintz - Health Care Viewpoints

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On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary (available here). The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units: (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit. In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021. This post focuses on the health care enforcement portion of the Fraud Section’s report. ....

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DOJ Healthcare Fraud Section 2020 Review: Action on Opioid Epidemic, Telemedicine, and COVID-19 | Pietragallo Gordon Alfano Bosick & Raspanti, LLP

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In a narrative that seems likely to be repeated in the coming year, the DOJ Healthcare Fraud Unit’s (HCF Unit) contribution to the Fraud Section’s 2020 Year in Review emphasized its enforcement action in three areas:
Opioid epidemic
COVID-19
With an entire year of healthcare delivery during a pandemic now behind us, and a new administration assessing its priorities, it is likely that the focus on each of these subjects will be broader and deeper in the coming year.
Two Focuses of the Take-Down Were Telemedicine and Substance Abuse Treatment Facilities ....

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DOJ Fraud Section 2020 Health Care Enforcement

Monday, March 8, 2021
On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary (available here). The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units: (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit. In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021. This post focuses on the health care enforcement portion of the Fraud Section’s report. ....

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Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG® Respiratory Panel Test Including SARS-CoV-2

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AUSTIN, Texas, March 4, 2021 /PRNewswire/ Luminex Corporation (NASDAQ: LMNX) today announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG
® Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company s original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and 2 bacterial targ ....

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