Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in November 2020. The company said it hopes for its latest EUA ahead o…

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Lucira Health asks FDA for EUA on molecular at-home COVID/flu test

Lucura Health’s COVID-19 & Flu test [Photo courtesy of Lucira]

Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test.

Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a sensitivity and specificity comparable to lab-based PCR assays, the company said, and runs on a palm-sized device for results from a single nasal swab within 30 minutes.

PCR tests pick up infectiousness faster than the rapid antigen tests commonly used at home, which are more likely to deliver false negatives and often don’t detect infections in the first few days when someone is contagious.

Lucira’s at-home COVID-19 test was the first to secure an EUA from the FDA in Novem…

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Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine. 

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia. 

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

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CueVac and GSK launch Phase 1 trial of mRNA-based flu vaccine

CureVac (NSDQ:CVAC) and GSK (NYSE:GSK) have announced the dosing of the first participant in a Phase 1 study of a multivalent influenza vaccine built on a second-generation mRNA backbone. The study is based in Panama and will enroll approximately 240 subjects.

CVAC shares increased 2.27% to $19.34 in mid-day trading.

At various points last year, however, the company’s stock was trading over $100 per share on enthusiasm about the company’s first-generation COVID-19 vaccine. However, the shares later tanked after the company announced that interim vaccine efficacy was 47% in the Phase 2b/3 study.

The company’s second-generation COVID-19 vaccine remains in pre-clinical development.

Its influenza vaccine candidate has multiple non-chemically modified mRNA constructs related to four different influenza strains.

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are also developing mRNA-based influenza vaccines.

Investors were dis…

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7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

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Intranasal FluGen vaccine offers protection in human challenge study

Madison, Wis.–based FluGen has announced that its Bris2007 M2SR flu vaccine candidate demonstrated protection against a multi-seasonal, seven-year drifted influenza strain in a Phase 2 study.

Some 54% of M2SR vaccine recipients were infected after exposure to a flu strain. Conversely, 71% of placebo recipients were infected, indicating that the vaccine was 24% effective against the strain.

The results, which were published in the Journal of Infectious Diseases, mark the first time a vaccine demonstrated the ability to protect against a highly drifted influenza A (H3N2) flu virus in a human challenge study, according to FluGen.

The study indicates that the vaccine triggers a broad immune response. Conversely, traditional flu vaccines offer strain-specific protection and struggle to protect against the H3N2 strain, which has driven an increasing proportion of flu cases in recent years.

In the challenge study, investigators randomized adults aged 18 …

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