Category Archives: AZBio News

C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials

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Resulting novel drug development tools will support patient-focused drug development for children with asthma

 

 

TUCSON, Ariz., April 21, 2020 — The Critical Path Institute (C-Path) announced today it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of ongoing development of novel clinical outcome assessments for pediatric asthma. C-Path’s Patient-Reported Outcome (PRO) Consortium will carry out this work through its Pediatric Asthma Working Group. Specifically, these assessments are intended to facilitate innovative patient-focused drug development and aid regulatory decision making by filling an unmet measurement gap.Continue reading→

GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

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  • FDA Emergency Use Authorization for the GSTM COVID-19 RT-PCR KIT was issued on April 16, 2020. View FDA Letter: https://www.fda.gov/media/137090/download
  • With a high sensitivity detection (single copy detection) when run according to its instructions for use in a qualified clinical lab, the GSTM COVID-19 RT-PCR test, is one of the most sensitive tests currently available under an FDA Emergency Use Authorization.
  • GSTM COVID-19 RT-PCR KIT runs on the Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument. Kits are available for the 96 well plate (22 clinical samples) and 384 well plate (94 clinical samples) and provides test results in less than 90 minutes.
  • The GSTM COVID-19 RT-PCR KIT is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Instructions for use, the FDA EUA letter, and other documentation is provided at GenoSensorCorp.com.

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UArizona Launches Two-Way Texting System to Gather and Provide Critical COVID-19 Health Data

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TUCSON, Ariz. – Designed to address a critical lack of local data as the COVID-19 pandemic continues to spread, a University of Arizona team of researchers from UArizona Health Sciences and the Data Science Institute is launching a two-way texting system to gather and provide valuable information to track the COVID-19 pandemic in Arizona and identify areas where more resources may be needed.

 

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Identifying Critical Infrastructure During COVID-19

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The Department of Homeland Security the CISA guidelines on essential critical infrastructure. The guideline has been updated from:

 “Workers conducting research critical to COVID-19 response” to  “Workers, including lab personnel who perform critical biomedical research, development, and testing, needed for COVID-19 response or other diseases”.

Learn more at: https://www.cisa.gov/identifying-critical-infrastructure-during-covid-19

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AZCERT ANNOUNCES OPEN ACCESS TO MEDSAFETY SCAN® FOR SAFE PRESCRIBING DURING COVID-19 PANDEMIC

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The decision support system is available free to medical professionals around the world.  

TUCSON, Ariz., April 20, 2020 — The Arizona Center for Education and Research on Therapeutics (AZCERT), a nonprofit dedicated to the safe use of medicines, is making MedSafety Scan®, a web-based decision support system, available free to medical professionals around the world, especially those treating high risk COVID-19 patients. MedSafety Scan can warn healthcare providers when their patients are prescribed drugs that place them at high risk of developing a potentially lethal cardiac arrhythmia known as torsades de pointes (TdP). MedSafety Scan also checks for potentially dangerous drug-interactions and suggests options for how to monitor the patient and reduce their risk of harm.Continue reading→

House Members Ask CMS to Expand Home Infusion Services

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On April 13, 2020, U.S. Representatives Eliot L. Engel (NY-16) and Fred Upton (MI-06), top Members of the Energy and Commerce Committee, led a bipartisan group of 181 House Members, including Arizona Representatives Andy Biggs, Ruben Gallego, Raul Grijalva, and Tom O’Halleran,  in urging the Trump Administration to temporarily allow seniors to receive lifesaving drug infusions in their homes to prevent unnecessary trips to hospitals, which could potentially expose them to COVID-19.
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Celebrating the Life of Jane Dee Hull, 20th Governor of the State of Arizona

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The Honorable Jane Dee Hull, 20th Governor of the State of Arizona and her husband Dr. Terry Hull have died of natural causes.

“Through 25 years of public service, Governor Hull steered Arizona through sometimes turbulent political times, providing steady leadership and an unwavering commitment to doing what’s right and ethical. She will be remembered for her strength of conviction, grace and ability to bring people together for the long-time benefit of all Arizonans.” — Governor Douglas A. Ducey   

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Ortho’s Total Antibody Test for COVID-19 Receives Emergency Use Authorization from FDA

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The U.S. Food and Drug Administration (FDA) today announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This test is one of the first high-throughput, automated* COVID-19 antibody tests to be granted Emergency Use Authorization.Continue reading→