Tuesday, February 7, 2023

561.316.3330

Biotechnology News Magazine

KSL | Pulse Scientific Named National Distributor in Canada for First-of-its-Kind COVID-19 & Flu At-Home Molecular Test

Developed by Lucira Health Inc., this 99% accurate test has been approved by Health Canada is now available in time for the COVID/Flu season

Latest Posts

Nectin Therapeutics to Collaborate with Merck on Clinical Trial of Anti-PVR Antibody NTX1088 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Locally Advanced and...

NTX1088 is a First-in-Class and highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors.

TransCure bioServices Offers BioVolume 3D Imaging for Insightful Preclinical Oncology Research

BioVolume reconstructs tumors from 3D, RGB, and thermal imaging. The solution is non-invasive, using a machine learning algorithm to automatically calculate subcutaneous tumor length, height, and width.

CLINUVEL Drug Significantly Reduces UV Skin Damage

“Today’s results build upon the decades of research CLINUVEL has conducted into the use of afamelanotide to protect skin from light, with the first evidence that a single dose of the drug has a photoprotective effect in healthy volunteers. These data add to our regulatory dossier for XP while further developing our specialised healthcare products for wider populations at highest risk of UV-induced damage and skin cancer,” Dr Bilbao said.

Deciphex Completes Validation Activities Enabling Veterinary Consultant Pathologists to Perform CLP Peer Review Digitally Using Patholytix

GLP and non-GLP studies can now be digitally peer reviewed by consultant pathologists for CROs and Pharma companies leading to faster study review and reduced backlogs with Drug candidates brought to clinical trials sooner advises Deciphex.

KSL | Pulse Scientific, specializing in diagnostic, medical and laboratory products, announced today national distribution of the first and only over-the-counter combination test for COVID-19 and Flu, packaged and designed for self-testing at home. Developed by Lucira Health Inc., the test has been approved by Health Canada and is now available to institutions, health care providers, agencies and consumers in time for the fall and winter COVID and Flu season. The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab.

“A good indicator of the coming flu season is often the recent season in Australia. Because Australia had an alarming spike in COVID and flu cases and we could see a substantial increase in North America. Many are projecting a ‘Twindemic’ of COVID and flu. Determining which infection someone has is difficult since flu and COVID present with similar symptoms. Lucira’s new product can be a game changer for medical staff and patients needing to determine the best course of action quickly,” says Kevin Lawson, President and CEO of KSL.

Lucira’s single-use test fits in the palm of a hand, runs on two AA batteries, and with one nasal swab, provides a positive or negative result for COVID-19, Flu A, and Flu B in 30 minutes or less. Each Lucira test is packaged with everything needed for the test. There is no separate reader or instrument to purchase and maintain.

“Lucira’s team did a great job developing this at-home test. We are ready to support the medical community and the public in Canada with ready access to fast and accurate testing,” add Lawson.

The Lucira testing platform is a Nucleic Acid Amplification Test (NAAT) with sensitivity and specificity comparable to lab-based PCR assays. Lucira’s standalone COVID-19 Test was the first at-home COVID-19 test to receive an EUA from the FDA in November 2020. The Lucira COVID-19 & Flu Test, which uses the same technology platform, was granted FDA EUA for point-of-care use earlier this month.

Health Canada has granted authorization under Interim Order No. 3. for emergency use and commercialization of this first and only at-home test for COVID & Flu. Health Canada’s decision is based on performance data including clinical trial results demonstrating comparable sensitivity and specificity to leading lab-based PCR assays.

The test also recently received CE marking, meeting EU health and safety requirements. Submissions to other regulatory authorities are in progress.

Inquiries can be sent to Pulse Scientific – https://www.pulsescientific.com/lucira-covid-19-and-flu-test

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine