COVID-19 News: COVID Plus monitor, BioFire respiratory panel, Screening vs Diagnostic Testing, Cure ID App

COVID PLUS Monitor

Tiger Tech Solutions, Inc.

INDICATION FOR USE: Non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation.

ADDRESSING UNMET NEED: First Machine Learning-Based screening device to identify certain biomarkers that may indicate COVID-19 infection. Combining use of this new screening device with temperature checks could help identify asymptomatic individuals.

DESCRIPTION:

  • Arm-band with two embedded photoplethysmography (PPG) sensors and a processor that is wrapped around the recipient’s bare left arm above the elbow
  • PPG sensors acquire direct pulsatile biosignals over 3-5 minutes; processor interprets signals
  • Fed into a probabilistic machine learning model trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation
  • Green light (not demonstrating biomarkers), red light (demonstrating biomarkers), blue light (test is inconclusive) due to indeterminate features

CLINICAL PERFORMANCE:

  • Validation study : Hospital study (n=467 asymptomatic individuals)
  • Positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6%
  • Negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5%
  • Confirmatory study: School study, with similar performance

REGULATORY PATHWAY: Emergency Use Authorization

EUA Authorization Letter

BioFire Respiratory Panel

Biofire Diagnostics

INDICATION FOR USE: PCR-based multiplexed nucleic acid test intended for use with the BioFire FilmArray 2.0 or BioFire FilmArray Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19.

ADDRESSING UNMET NEED: Multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab.

DEVICE TYPE: Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

Is for use only for people suspected of respiratory tract infections, including COVID-19. 

Should be used by health care providers in combination with a clinical examination and consideration of patient medical history.

REGULATORY PATHWAY: First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review – De Novo pathway

  • Regulation Number: 21 CFR 866.3981
  • Regulatory Class: Class II
  • Product Code: QOF

CLASSIFICATION ORDER

Screening vs Diagnostic Testing

Diagnostic testing: Identifies current infection at the individual level and is performed when a person has signs or symptoms of infection, or when a person is asymptomatic but has recent known or suspected exposure.

Screening testing: Looks for individual infections in a group even if there is no reason to, Testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions based on the test results.

Test developers decide the use they will seek to have authorized by the FDA.

The FDA issued a new supplemental template for test developers seeking EUA of certain tests for screening with serial testing.

FACT SHEET

CURE ID App receives award

 CURE ID is an internet-based repository for clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases

  • Collaboration between FDA, National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), and World Health Organization (WHO)
  • Critical updates to app to allow clinicians to more easily report their real-world experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial
  • Received 2021 Golan Christie Taglia Patient Impact Philanthropy Award

App


Image credit: FDA, Tiger Tech, BioFire

News and Views: Fraudulent FDA ‘registered’ products, Reporting misconduct, Data modernization plan, Real World Evidence for regulatory decision making

FDA Registered” or “FDA Certified” Medical Devices are not FDA approved

Misleading website claims of FDA Registered, FDA Certified, FDA Registration Certificate aometimes along with FDA logo

  • Manufacturers register annually with the FDA for the production and distribution of medical devices intended for use in the US
  • However, entry in the FDA’s registration and listing database does not denote approval, clearance
  • Also,  FDA does not issue any type of device registration certificates to medical device facilities.
  • Firms misleadingly displaying certificates to imply review or approval by FDA are misbranding’ the product and are in violation of the Federal Food, Drug, and Cosmetic Act
  • Check for Approved and Cleared Products in the Devices@FDA Database

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Reporting Allegations of Regulatory Misconduct

Allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law

  • Make the FDA aware of regulatory concerns it may not learn of otherwise
  • Help the FDA identify the potential risks to patients

Examples include: False promotion or advertising of a device, not submitting required safety reports, noncompliant manufacturing practices, failing to register/list product, not meeting import requirements, document falisfication etc.

Submit an allegation through the Allegations of Regulatory Misconduct Form

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Data Modernization Action Plan for Putting Data to Work for Public Health

Data Modernization Action Plan (DMAP) to modernize FDA’s technical infrastructure

  1. Identify and execute high value driver projects for individual centers and for the Agency;
  2. Develop consistent and repeatable data practices across the Agency; and,
  3. Create and sustain a strong talent network combining internal strengths with key external partnerships.

DMAP driver projects will contribute to the FDA’s public health responsibilities in the near term while also building critical capabilities for the future.  

DMAP

Graphic with the words Real World Data and Real World Evidence and the acronyms RWD and RWE and icons of a stethoscope, beakers, computer monitor and a heart

Leveraging Real World Evidence in Regulatory Submissions of Medical Devices

Real World Evidence (RWE) is the clinical evidence regarding the usage, and benefits and risks, of a medical product derived from the analysis of Real World Data (RWD)

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Image credit: FDA

COVID-19 News: Cue OTC test, EUA Public FAERS dashboard, Roche false results, Ivermectin warning, Learn about treatment options

CUE Test for Home and Over The Counter (OTC) Use

Cue Health

INDICATION FOR USE: Qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand.

Intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. For Home and OTC use
authorized for non-prescription home use.

ADDRESSING UNMET NEED: First molecular OTC diagnostic test to continue to expand access to testing to help us in the fight against the pandemic

DESCRIPTION:

  • For qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand
  • Test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader the Cue Health Mobile Application (App)
  • Battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes

SENSITIVITY and SPECIFICITY:

  • Correctly identified 96% of positive samples from individuals known to have symptoms
  • Correctly identified 100% of positive samples from individuals without symptoms

REGULATORY PATHWAY: EUA

AUTHORIZATION ORDER

New COVID-19 EUA FAERS Public Dashboard 

Launch of FDA Adverse Event Reporting System (FAERS) Public Dashboard to access data on adverse events

  • User-friendly search tool for adverse events associated with the use of drugs and biologics
  • Provides weekly updates of adverse event reports and increases transparency and provide more efficient access to safety information.

DASHBOARD

Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test

False positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System

  • Assay tubes may sporadically leak, causing an obstructed optical path in the Liat analyzer, producing abnormal PCR growth curves
  • Abnormal PCR cycling in the reaction tubes may also produce abnormal PCR growth curves, leading to erroneous results

Recommendations

  • Monitor for unexpected clusters of positive Flu B results
  • Repeat tests when two or three analytes are positive
  • Stop using the cobas Liat System and contact Roche if you suspect issues

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Ivermectin should not be used treat or prevent COVID-19

Ivermectin has not been approved for treating or preventing COVID-19

  •  Approved to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms
  • Different formulation used in animals to prevent heartworm disease and certain internal and external parasites 
  • FDA has not reviewed data to support use in COVID-19 patients; some initial research is underway
  • Taking ivermectin is dangerous: Interaction with other medications e.g. blood-thinners, potential to overdose with nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death

READ

picture of patient and doctor

Learn about treatment options available today


Image credit: Cue, Roche, FDA

COVID-19 News: Janssen vaccine EUA, Pfizer-BioNTech vaccine flexibilities, Vaccine safety surveillance, Pulse oximeter limitations, Virus variants policies

Janssen COVID-19 Vaccine EUA

INDICATION: For the prevention of coronavirus disease 2019 for use in individuals 18 years of age and older; administered as a single dose

ADDRESSING UNMET NEED: Expands the availability of vaccines, the best medical prevention method to help us in the fight against the pandemic

MECHANISM OF ACTION: Uses modified Ad26 to deliver a piece of the DNA to make virus “spike” protein; body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2

EFFECTIVENESS, SAFETY, QUALITY:

Effectiveness

  • Ongoing randomized, placebo-controlled study, n=39,321, being conducted in South Africa, South America, Mexico, U.S, did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine, Vaccine vs placebo
  • ~ 67% effective in preventing moderate to severe/critical COVID-19 occurring 14 days after vaccination
  • ~ 66% effective in preventing moderate to severe/critical COVID-19 occurring 28 days after vaccination
  • ~77% effective in preventing severe/critical COVID-19 occurring 14 days after vaccination
  • ~85% effective in preventing severe/critical COVID-19 occurring 28 days after vaccination
  • No evidence on prevention of person to person transmission

Safety

  • N= 43,783, vaccine vs. placebo, followup of 8 weeks (median)
  • Most commonly reported side effects: Pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
  • Need to report adverse safety and vaccine administration errors to iVaccine Adverse Event Reporting System (VAERS)

Quality

  • All manufacturing facilities will comply with Current Good Manufacturing Practice
  • File Certificates of Analysis (CoA) established specifications and specific results for each quality control test
  • File quarterly manufacturing reports with listing of all Drug Substance and Drug Product lots produce

REGULATORY PATHWAY: EUA

  • Provide fact sheets on dosing instructions, benefits and risks providers and recipients
  • Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)
  • Conduct post-authorization observational studies to evaluate adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19

AUTHORIZATION

close up of syringe

More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Undiluted frozen vials can be transported and stored at conventional freezer temperatures

  • Based on data to demonstrate stability after storage up to two weeks at standard freezer temperature
  • Will help ease burden of procuring ultra-low cold storage equipment and help get vaccine to more sites

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Vaccine Safety and Surveillance

Webpage to provides overview of surveillance systems to monitor safety of authorized COVID-19 vaccines

  • Data from FDA’s CBER + CDC + CMS + VA + other academic and large non-government healthcare data systems
  • Includes international pharmacovigilance efforts, including International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)

Passive surveillance: Reviewing data from FDA’s Vaccine Adverse Event Reporting System (VAERS) , CDC’s  v-safe text-based monitoring system 

Active surveillance: Analyzing large healthcare data systems such as Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS system

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Pulse Oximeter Accuracy and Limitations

Pulse oximeters may be less accurate in people with dark skin pigmentation

  • Risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels
  • Important to understand the limitations of pulse oximetry and how accuracy is calculated and interpreted
  • Prescription oximeters are reviewed and authorized by the FDA an used in hospitals and doctor’s offices
  • Over-the-counter (OTC) oximeters are sold directly to consumers, are not cleared by the FDA and should not be used for medical purposes.
  • Important recommendations for patients and their caregivers on how to use pulse oximeters at home
  • Recommendations for health care providers on how to use pulse oximeters for better accuracy
  • Background on pulse oximeters and the FDA’s actions to evaluate factors that may affect pulse oximeter accuracy and performance
  • Instructions for reporting problems with pulse oximeters to the FDA

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Policies for Addressing Virus Variants: Vaccines, Diagnostics and Therapeutics

Guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products

Vaccines : Updated October 2020 guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19

COVID-19 Tests: New guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests

Therapeutics: New guidance, Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. Revised guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.

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Image credit: FDA, CDC