PharmaJet Tropis becomes exclusive intradermal delivery system for 2 COVID-19 vaccines

The Tropis needle-free injection system. [Image from PharmaJet]PharmaJet announced that its Tropis system is now the exclusive intradermal delivery system for two novel COVID-19 vaccines.

Golden, Colorado-based PharmaJet engineers precision delivery systems that overcome the challenges of nucleic acid vaccine delivery. Its Tropis system now offers the delivery of the world’s first plasmid DNA COVID-19 vaccine from Zydus Lifesciences. Exclusively delivered with Tropis, the vaccine demonstrated increased immune response translating into clinical effectiveness, PharmaJet says.

Additionally, Tropis delivers Gennova Biopharmaceutical’s mRNA-based Omicron-specific COVID-19 booster vaccine. The self-amplifying therapeutic enables a low dose of a room temperature, stable mRNA vaccine.

Get the full story at our sister site, Drug Delivery Business News.

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Adhesive bandage with nanoparticles tests for COVID-19

[Photo by Martin Sanchez on Unsplash]

NYU Abu Dhabi researchers say they have a new rapid COVID-19 testing method using an adhesive bandage.

This bandage uses gold nanoparticles to quickly detect the immune antibodies in the bloodstream. SARS-CoV-2 infection naturally produces these antibodies, known as IgM and IgG. They serve as valuable biomarkers to identify infected individuals and monitor the spread of pandemics.

Associate Professor of Mechanical Engineering and Bioengineering Mohammad Qasaimeh led the NYU Abu Dhabi research team. They had their work published in a paper in the journal Microsystems and Nanoengineering.

“Our goal is to contribute to improved diagnostics and help individuals with their health management, ultimately enhancing our ability to combat and control infectious diseases on a global scale,” said Imen Boumar, one of the first authors of the study and a former research ass…

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The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

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Cue Health wins FDA de novo authorization for home COVID-19 test

The Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health]Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test.

San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any home-use respiratory test, according to a news release.

Cue Health originally made its COVID-19 test available to consumers without a prescription in 2021. That availability came under the FDA’s emergency use authorization (EUA), a widely used pathway for COVID-19-related products.

The molecular test delivers results in just 20 minutes to connected mobile smart devices. It demonstrated overall accuracy of 98%, detecting all known COVID-19 variants of concern. The test also integrates into Cue Care, the company’s state-of-t…

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Glowing nanoparticles enhance at-home COVID-19 test sensitivity

This glowing star inspired glow-in-the-dark COVID-19 testing technology developed by Richard Willson and his team at the University of Houston. [Image courtesy of the University of Houston)

Researchers at the University of Houston are using glow-in-the-dark materials to enhance the sensitivity of rapid COVID-19 home diagnostics.

The widely used lateral flow assay provides rapid results for diagnostics such as at-home COVID-19 or pregnancy tests. They also offer low costs and ease of operation. Test results on LFA diagnostics come through in colored lines.

“We are making those lines glow-in-the-dark so that they are more detectable, so the sensitivity of the test is better,” said Richard Willson, who’s leading the University of Houston team. 

Willson is the Huffington-Woestemeyer professor of chemical and biomolecular engineering at the UH Drug Discovery Institute and a professor of biochemic…

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This T-cell vaccine could be the future of COVID-19 protection

[Image courtesy of Production Perig/Adobe Stock]

The current mRNA vaccines from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) stimulate the production of neutralizing antibodies that bind to the spike protein of SARS-CoV-2.

But there is a novel mRNA vaccine that activates T cells to attack cells infected with the virus. Developed by researchers at MIT and other institutions, the new vaccine could sidestep the need for updated boosters based on currently circulating variants.

In a preclinical study published in Frontiers in Immunology, the T-cell vaccine successfully attacked cells infected with the virus rather than activating the part of the immune system that releases neutralizing antibodies. In addition, the researchers tested the vaccine in humanized mice and successfully generated both CD8+ (cytotoxic) and CD4+ (helper) T-cell responses.

This new MIT-T-COVID vaccine could …

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How the BD diagnostics business is driving greater access to care

The BD Max system. [Image courtesy of BD] It’s been a busy time for BD, with recent approvals further driving the company’s diagnostics business forward.

Dave Hickey and BD (NYSE:BDX) have their sights on what they call “transformative forces.” These forces could change the delivery of healthcare going forward.

Hickey, EVP and president of the Life Sciences segment at BD, said these forces include smart connected care, migration to new care settings and improving chronic disease outcomes.

Digitization and automation, plus point-of-care and at-home testing, comprise these areas. That’s where BD’s focus lies.

“Our innovation strategy and our investment dollars are going into those areas,” Hickey told MassDevice.

Recent news along these lines includes the February FDA emergency use authorization (EUA) for BD’s COVID-19, flu and RSV combination diagnostic. Just weeks later, the company received app…

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FDA extends shelf life of some popular COVID tests

[Image courtesy of Abbott]The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life.

Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates.

The Abbott BinaxNow COVID-19 antigen self tests now have a shelf life of 22 months. Previously, the popular test had a 15-month shelf life.

Maxim Biomedical’s ClearDetect COVID-19 antigen home test initially received authorization with an eight-month shelf life. The FDA announced that it extended the shelf life of that test to 12 months.

iHealth Labs COVID-19 antigen rapid tests received a three-month extension from 12 months to 15 months.

“The expiration dates for these tests have been extended to reflect the longer shelf-life,” the FDA said in a notice. The agency based its extension on additional data provided by the manufacturers. This data demons…

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3D-printed nasal swab wins Patents for Humanity award

The 3D-printed swab team helped solve a global shortage, sharing their design for free with organizations that produced more than 100 million swabs. [Image courtesy of USF]

The University of South Florida received the Patents for Humanity award for its patent of a 3D-printed nasopharyngeal swab.

Developers created the swab in the early part of the COVID-19 pandemic to solve production disruptions during a time of critical need for COVID-19 testing.

The U.S. Patent and Trademark Office (USPTO) awarded USF with the Patents for Humanity prize. Other recipients of awards include the National Institute of Allergy and Infectious Diseases of the NIH, Regeneron Pharmaceuticals, Gilead Sciences Inc., and Caron Products. The USPTO plans to celebrate the winners at an awards ceremony on Feb. 16, 2023.

Due to the urgent global need for swabs, USF’s team decided to forgo monetization of its invention, th…

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Pfizer seeks EUA for omicron booster for under-5 kids

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5.

The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.

The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer and BioNTech are seeking a sim…

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LivaNova LifeSparc ACS pump cleared for extended use

LifeSparc includes a sterile, on-patient pump. The reduced circuit surface area decreases inflammatory response and eliminates the need for a heater/cooler. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).

The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.

In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.

“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, director of Cardiogenic Shock at the Heart H…

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Bio-Rad stock dips as COVID-19-related sales taper off in Q3

Bio-Rad (NYSE:BIO) shares took a hit on third-quarter results that came in mixed compared to the consensus forecast.

BIO shares were down more than 6% at $359.75 apiece this morning — a day after the company released its results. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 2%.

The Hercules, California–based clinical diagnostics company posted losses of $164.2 million for the quarter. That’s a loss of $5.52 per share on sales of $680.8 million for the three months ended Sept. 30, 2022.

Bio-Rad registered a massive bottom-line slide into the red on a sales decline of 8.9%. Life sciences sales sank by 14.9% for the quarter. Lower COVID-related sales, legal settlements in the year-ago period and supply chain constraints led to the dip. Excluding COVID-19-related sales and legal settlements, the segment grew by 9.4%.

Additionally, Bio-Rad’s clinical diagnostics …

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