BioCentury | Sep 18, 2020
Product Development

Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

...media. FDA data was available for one saliva...
BioCentury | Aug 27, 2020
Product Development

COVID-19 Quick Takes: FDA authorizes 15-minute, $5 antigen test from Abbott; plus  updates from IDSA, CEPI, Novavax, VBI, Verndari, AZ, Fluidigm, Tyme

...“Regeneron Leads Antiviral Antibody Pack”).EUA for Fluidigm’s saliva...
...FDA granted EUA to Advanta Dx, a saliva-based...
BioCentury | Aug 18, 2020
Product Development

SalivaDirect slots into growing matrix of resource-saving COVID-19 tests

...other resource-saving strategies by being optimized for saliva...
...Saturday, FDA authorized SalivaDirect to detect SARS-CoV-2 RNA in saliva ...
...testing more palatable, optimizing the test for saliva...
BioCentury | Aug 8, 2020
Product Development

Asymptomatic COVID-19 testing pushes forward, with lessons from cancer

...are feasible to run in a week will play a role. For example, a daily saliva...
BioCentury | Aug 6, 2020
Product Development

BioNTech testing separate mRNA vaccine variant in Chinese trial, closes supply deal with Canada

...and ImmunityBio’s vaccine, plus Clinical Reference Laboratory scored an Emergency Use Authorization (EUA) for its saliva...
...to express the SARS-CoV-2 spike and nucleocapsid. Separately, FDA has granted an EUA to a saliva-based...
...transcriptase PCR-based COVID-19 test, CRL Rapid Reponse, from Clinical Reference Laboratory Inc. Individuals can collect saliva...
BioCentury | Aug 1, 2020
Translation in Brief

TScan identifies CD8+ T cell COVID-19 epitopes, plus T3 gears up for Phase I of bacterial cancer therapy, a wearable device to monitor PK and a COVID-19 vaccine

...for personalized therapeutic drug PK monitoring that works by sensing electrical changes in sweat or saliva...
...of acetaminophen PK highly correlated with the drug’s saliva-based profile. Previous studies had correlated acetaminophen’s saliva...
BioCentury | Jul 25, 2020
Product Development

NIH, HHS fast-tracking point-of-care, pooled tech as way out of testing crunch

...reporting systems designed for non-experts. Applicants are also exploring a range of sampling strategies, including saliva...
BioCentury | Jun 26, 2020
Distillery Therapeutics

Biocryst’s galidesivir effective against Zika in macaques

...starting 1.5 hours after subcutaneous infection reduced Zika virus RNA levels in the plasma, CSF, saliva...
BioCentury | May 9, 2020
Product Development

FDA authorizes first COVID-19 test using at-home saliva samples, begins unveiling serological test validation data

...Rutgers University marks the first time the agency has signed off on detecting SARS-CoV-2 from saliva...
...lab, can be run on samples self-collected by patients using the Spectrum Solutions LLC SDNA-1000 Saliva...
BioCentury | May 7, 2020
Regulation

CRISPR comes of age years ahead of schedule with first diagnostic authorization

...a fluorescent reader. The test’s limit of detection was 100 copies of viral genome in saliva...
Items per page:
1 - 10 of 249
BioCentury | Sep 18, 2020
Product Development

Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

...media. FDA data was available for one saliva...
BioCentury | Aug 27, 2020
Product Development

COVID-19 Quick Takes: FDA authorizes 15-minute, $5 antigen test from Abbott; plus  updates from IDSA, CEPI, Novavax, VBI, Verndari, AZ, Fluidigm, Tyme

...“Regeneron Leads Antiviral Antibody Pack”).EUA for Fluidigm’s saliva...
...FDA granted EUA to Advanta Dx, a saliva-based...
BioCentury | Aug 18, 2020
Product Development

SalivaDirect slots into growing matrix of resource-saving COVID-19 tests

...other resource-saving strategies by being optimized for saliva...
...Saturday, FDA authorized SalivaDirect to detect SARS-CoV-2 RNA in saliva ...
...testing more palatable, optimizing the test for saliva...
BioCentury | Aug 8, 2020
Product Development

Asymptomatic COVID-19 testing pushes forward, with lessons from cancer

...are feasible to run in a week will play a role. For example, a daily saliva...
BioCentury | Aug 6, 2020
Product Development

BioNTech testing separate mRNA vaccine variant in Chinese trial, closes supply deal with Canada

...and ImmunityBio’s vaccine, plus Clinical Reference Laboratory scored an Emergency Use Authorization (EUA) for its saliva...
...to express the SARS-CoV-2 spike and nucleocapsid. Separately, FDA has granted an EUA to a saliva-based...
...transcriptase PCR-based COVID-19 test, CRL Rapid Reponse, from Clinical Reference Laboratory Inc. Individuals can collect saliva...
BioCentury | Aug 1, 2020
Translation in Brief

TScan identifies CD8+ T cell COVID-19 epitopes, plus T3 gears up for Phase I of bacterial cancer therapy, a wearable device to monitor PK and a COVID-19 vaccine

...for personalized therapeutic drug PK monitoring that works by sensing electrical changes in sweat or saliva...
...of acetaminophen PK highly correlated with the drug’s saliva-based profile. Previous studies had correlated acetaminophen’s saliva...
BioCentury | Jul 25, 2020
Product Development

NIH, HHS fast-tracking point-of-care, pooled tech as way out of testing crunch

...reporting systems designed for non-experts. Applicants are also exploring a range of sampling strategies, including saliva...
BioCentury | Jun 26, 2020
Distillery Therapeutics

Biocryst’s galidesivir effective against Zika in macaques

...starting 1.5 hours after subcutaneous infection reduced Zika virus RNA levels in the plasma, CSF, saliva...
BioCentury | May 9, 2020
Product Development

FDA authorizes first COVID-19 test using at-home saliva samples, begins unveiling serological test validation data

...Rutgers University marks the first time the agency has signed off on detecting SARS-CoV-2 from saliva...
...lab, can be run on samples self-collected by patients using the Spectrum Solutions LLC SDNA-1000 Saliva...
BioCentury | May 7, 2020
Regulation

CRISPR comes of age years ahead of schedule with first diagnostic authorization

...a fluorescent reader. The test’s limit of detection was 100 copies of viral genome in saliva...
Items per page:
1 - 10 of 249