The authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using their molecular LDT COVID-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. FDA states “It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”
Author Archive: AZBio
Quidel Receives Emergency Authorization for Rapid Antigen COVID-19 Diagnostic Assay
Sofia® 2 SARS Antigen FIA Point-of-Care test offers positive results in 15 minutesContinue reading
Q&A: Dr. Mary-Ann Etiebet, Executive Director, Merck for Mothers
With Mother’s Day just around the corner, BIO sat down with Dr. Mary-Ann Etiebet, Executive Director of Merck for Mothers, for a discussion about how Merck helping address maternal health needs in the United States and in countries impacted by COVID-19. Continue reading
Health Catalysts Group publishes The Diagnostics Year in Review
Led by diagnostics industry veteran Mara G. Aspinall, Health Catalysts Group is an Arizona based consulting and informatics firm focused on the success of life sciences companies.
The ALS Association Makes Multi-Year Commitment to ALS Clinical Trial Infrastructure
Funding will support a framework for greater efficiencies, collaboration in research, and enhanced patient experience during clinical trialsContinue reading
Treating COVID-19 Patients With Acute Heart Failure
A paper published in two medical journals last week offers guidelines for physicians treating coronavirus patients requiring advanced life-saving therapies.Continue reading
UArizona Health Sciences Researchers Identify Potential Pathway to Make Opioids Safer, More Effective
Researchers from the UArizona College of Medicine – Tucson found that inhibiting heat shock protein 90 in the spinal cord enhanced effectiveness of opioid therapy and could decrease its side effects.Continue reading
TGen and HonorHealth Initiate COVID-19 Combination Therapy of Atovaquone and Azithromycin
Established combination seen as safer option for coronavirus therapy; will add data to TGen COVID Immunity Study and virus sequencing effortsContinue reading
USPTO Launches Patents 4 Partnerships
USPTO launches platform to facilitate connections between patent holders and potential licensees in key technologies. Initial release focuses on COVID-19–related technologiesContinue reading
Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program
- First participants dosed at NYU Grossman School of Medicine and University of Maryland School of Medicine
- Pfizer and BioNTech ramping up manufacturing capabilities to further increase production capacity in 2020/2021