COVID-19 News: BinaxNOW Ag Card + NAVICA app, Advisory Committee to discuss vaccine development, Convalescent plasma, Pooled sample testing and screening, Hand sanitizer warning

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

DESCRIPTION:

  • 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.

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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

READ & ATTEND


VEKLURY (remdesevir)

Gilead

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

EFFICACY & SAFETY:

  • 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.

REGULATORY PATHWAY: Expanded EUA

FACT SHEET


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

FACTSHEET


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

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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

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Image credit: Abbott, Gilead, FDA

COVID News: SalivaDirect, Device shortage list, Your digital health, Hand sanitizer warning, Steps to stop spread, Convalescent plasma toolkit

SalivaDirect

Yale School of Public Health

INTENDED USE & DESCRIPTION: For rapid detection of SARS-CoV-2 using saliva instead of respiratory swabs, which enables non-invasive frequent sampling and reduces the need for trained healthcare professionals during collection.

VALIDATION:

  • With different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs
  • Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol
  • Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA

REGULATORY PATHWAY: Emergency Use Authorization (EUA)

  • Fifth test that uses saliva as a sample for testing

Publication


Device Shortage List

FDA monitoring healthcare landscape and supply chain for resulting shortages, or meaningful disruptions to U.S. supply, of certain medical devices

  • Manufacturers of certain devices notify FDA of permanent discontinuance in manufacture of the device
  • Interruption in the manufacture of device that is likely to lead to meaningful disruption in supply during declared public health emergency
  •  Categories of devices in the device shortage list are (1) Personal Protective Equipment (2) Testing Supplies and Equipment (3) Ventilation-Related Products

Device shortage and discontinuance list


FDA Insights: Your Digital Health

Discission on telemedicine, digital health tools, and FDA’s new Digital Health Center of Excellence

Listen , Digital Health page

Hand Sanitizers Consumers Should Not Use

Hand sanitizer products labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol and methanol contamination

  • Young children, adolescents and adults who drink these products as an alcohol (ethanol) substitute are at risk
  • Can cause central nervous system (CNS) depression, which can result in death
  • Exposure can include confusion, decreased consciousness, and slowed pulse and breathing
  • Skin or eye exposure can result in irritation, and rare cases of allergic skin reactions have been reported.

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Help Stop the Spread of Coronavirus and Protect Your Family

Remain vigilant and take simple steps

  • Wash Your Hands
  • Wear a Mask and Avoid Crowds 
  • Save Personal Protective Equipment for Those on the Front Lines
  • Follow Food Safety Guidelines
  • Donate Blood 
  • If You Have Fully Recovered From COVID-19, Donate Plasma
  • Report Fraudulent Coronavirus Tests, Vaccines, and Treatments

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The Fight Is In Us: Convalescent Plasma Fact Sheets and Toolkit

FDA working together with health care organizations and other partners to slow spread and meeting the challenge of COVID-19


Image credits: Yale, FDA

FDA COVID News: Operation Quack Hack for fraud prevention, Test for IgG antibodies from previous infection, Test for screening prople without known infection, Advanced manufacturing for preparedness, Plasma donation, COVID and Cancer website

FDA Protects Patients and Consumers from Fraud During COVID-19

Operation Quack Hack leverages agency expertise and advanced analytics to protect consumers from fraudulent medical products during the COVID-19 pandemic

  • As of June 2020, team has identified more than 700 fraudulent and unproven medical products 
  • Has reviewed thousands of websites, social media posts, and online marketplace listings
  • > 90 warning letters to sellers, more than 150 reports sent to online marketplaces, and more than 250 abuse complaints sent to domain registrars to date.

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First Tests to Estimate Patient’s IgG Antibodies from Past SARS-CoV-2 Infection

ADVIA Centaur COV2G and Atellica IM COV2G, Siemens

COVID-19 serology tests to estimate quantity of antibodies present in the individual’s blood

  • Useful tool to evaluate antibodies to a previous COVID-19 infection
  • Still many unknowns about what the presence of SARS-CoV-2 antibodies and potential immunity
  • Patients cautioned against using the results as an indication to stop taking steps to protect themselves and others
  • Instructions for Use

Advanced Manufacturing to Support Public Health Preparedness

Many medical products are still being manufactured using outdated technologies

  • Can increase the risk of shortages, limit flexibility during an emergency, and contribute to high cost
  • Encouraging “advanced manufacturing,” which refers to new and emerging approaches for production of medical technologies
  • Examples include process intensification methods, such as continuous manufacturing, 3D printing can help produce patient-specific medical devices, digital and smart design and manufacturing processes to increase efficiency and reduce uncertainty
  • READ

First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

LabCorp COVID-19 RT-PCR Test EUA

For testing people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing 

  • Step toward the type of broad screening that may help enable the reopening of schools and workplaces
  • Also test pooled samples containing up to five individual swab specimens collected under observation
  • Help receiving results sooner, while also conserving vital testing supplies
  • Prescription-only and is authorized for human specimen collection either at home or by a health care provider
  • Only health care provider-collected samples may be pooled at this time
  • Test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19
  • EUA Summary

If you have recovered from COVID-19, confirmed by a positive test, you’re in a special position to help us fight the virus. Donate plasma now


New Website on Cancer and COVID-19

FDA Oncology Center of Excellence recognizes cancer patients constitute a vulnerable population at risk ; current priorities

  • Expedite oncology product development
  • Recognize that modifications may be required in clinical trials
  • Innovating collection and analysis of real-world evidence on patient outcomes
  •  Process Expanded Access requests for investigational products
  • Anticipate and prevent drug shortages
  • Inform the cancer community

Cancer and COVID-19


Image credits: FDA, Labcorp, Siemens