BinaxNOW COVID-19 Ag Card & NAVICA App

Abbott Diagnostics

INDICATION: Antigen test where results can be read directly from the testing card to manage risk by quickly identifying infectious people so they don’t spread the disease to others.  Authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset. NAVICA™ app will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result

ADDRESSING UNMET NEED: First Diagnostic Test Where Results Can Be Read Directly From Testing Card

  • Highly portable (about the size of a credit card) and provides results in 15 minutes
  • Simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer


  • Antigen test using lateral flow technology
  • A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added
  • After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result
  • Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions

REGULATORY PATHWAY: Emergency Use Authorization

  • Clinical study with several leading U.S. research universities demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 within the first seven days of symptom onset

 Abbott will sell this test for $5.


Advisory Committee Meeting to Discuss COVID-19 Vaccines

Public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020

  • To discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19
  • Assure that the process and review for vaccine development will be open and transparent
  • Committee made up of outside scientific and public health experts from around the country
  • Public discussion of clinical development of COVID-19 vaccines and data to support safety and effectiveness


VEKLURY (remdesevir)


INDICATION:  Treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.  Specifically, Veklury is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous (IV) agent is clinically appropriate.

MECHANISM OF ACTION: Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor


  • One randomized, double-blind, placebo-controlled, n=1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group. In hospitalized patients with mild to moderate disease, the results for time to recovery as well as the odds of improvement at Day 15 numerically favored the Veklury group and were consistent with the overall study results.
  • A separate randomized, open-label multi-center trial,  hospitalized adult subjects with moderate COVID-19 treatment with Veklury for five days (n=191) and treatment with Veklury for 10 days (n=193) with standard of care (n=200). Odds of subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different
  • Possible side effects include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.



Convalescent Plasma

Convalescent plasma from individuals who have recovered from COVID-19 has not been approved for use by FDA, so it is regulated as an investigational product


Pooled Sample Testing and Screening Testing

FDA encouraging the development of tests for screening asymptomatic individuals and for testing pooled samples

  • Involves mixing several samples together in a “batch” or pooled sample, then testing the pooled sample with a diagnostic test
  • Increases the number of individuals that can be tested using same amount of resources
  • However, because samples are diluted, which could result in less viral genetic material available to detect, there is a greater likelihood of false negative results
  • Works well when there is a low prevalence of cases, meaning more negative results are expected than positive results
  • Several resources being provided


Warning: Hand Sanitizer Packaged in Food and Drink Containers

FDA warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks

  • Being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles
  • Containing food flavors, such as chocolate or raspberry
  • May put consumers at risk of serious injury or death if ingested


Image credit: Abbott, Gilead, FDA