Detection limit

Qorvo® Biotechnologies Receives FDA Emergency Use Authorization (EUA) for Rapid COVID-19 Antigen Testing at the Point of Care

Retrieved on: 
Thursday, August 4, 2022

The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories.

Key Points: 
  • The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories.
  • This EUA significantly expands the market for Qorvo beyond laboratories to include physician offices, urgent care centers, retail pharmacies, employee health testing, and any other locations where CLIA waived tests can be performed.
  • The Qorvo Omnia platform provides a unique combination of performance, automated workflow and scalability to serve on-site testing needs in a very efficient manner."
  • Qorvo is a registered trademark of Qorvo, Inc. in the U.S. and in other countries.

Bionano Genomics Announces Publication of Comprehensive Validation of Optical Genome Mapping for Hematologic Neoplasms

Retrieved on: 
Friday, March 18, 2022

SAN DIEGO, March 18, 2022 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO), pioneer of optical genome mapping (OGM) solutions on the Saphyr® system and provider of NxClinical™, the leading software solution for visualization, interpretation and reporting of genomic data, today announced the publication of comprehensive study results validating OGM for routine production use for genome-wide structural variant (SV) detection in hematological neoplasms.

Key Points: 
  • The 59 hematological neoplasms consisted of 43 simple and 16 complex cases, which included all classes of SVs.
  • To evaluate technical and analytical reproducibility, inter-run, intra-run and inter-instrument comparisons were performed on six samples in triplicates.
  • This publication is available at: https://www.medrxiv.org/content/10.1101/2022.03.14.22272363v1
    Bionano Genomics is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine.
  • The Companys mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software.

Pluslife Biotech - A Greater Bay Area Company Launches First Handheld Covid-19 Nucleic Acid Test

Retrieved on: 
Monday, February 14, 2022

HONG KONG, Feb. 13, 2022 /PRNewswire/ --Recently, Pluslife Biotech, an enterprise based in the Greater Bay Area, launched the first handheld Covid-19 Nucleic Acid Test to help with epidemic prevention and control.

Key Points: 
  • HONG KONG, Feb. 13, 2022 /PRNewswire/ --Recently, Pluslife Biotech, an enterprise based in the Greater Bay Area, launched the first handheld Covid-19 Nucleic Acid Test to help with epidemic prevention and control.
  • Although rapid antigen test is simple and convenient to use, its sensitivity is significantly lower than that of qPCR test.
  • Pluslife Biotech is a developer and manufacturer of POCT nucleic acid testing & home-test products based in the Greater Bay Area.
  • Pluslife Mini Dock, developed by Pluslife Biotech, is the first handheld POCT nucleic acid testing product for COVID-19.

Lucira™ Check-It PCR-Quality, At-Home Molecular COVID-19 Test Now Available in the Optum Store

Retrieved on: 
Tuesday, January 11, 2022

The Lucira Check-It (OTC) and All-In-One (Rx) test kits are molecular Nucleic-Acid Amplification Tests (referred to as NAAT).

Key Points: 
  • The Lucira Check-It (OTC) and All-In-One (Rx) test kits are molecular Nucleic-Acid Amplification Tests (referred to as NAAT).
  • Each Lucira test kit contains everything needed to run one COVID-19 test.
  • Lucira designed its test kits to provide accurate, reliable, and on-the-spot molecular test results anywhere and at any time.
  • The Lucira Check-It COVID-19 Test Kit (OTC) and Lucira COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Lucira Health and Co-Defend/Co-Protect Announce Expanded Partnership for 2022

Retrieved on: 
Wednesday, December 29, 2021

Lucira's superior testing technology combined with our broad distribution channels will make an immediate positive impact on public health."

Key Points: 
  • Lucira's superior testing technology combined with our broad distribution channels will make an immediate positive impact on public health."
  • The Lucira Check-It (OTC) and All-in-One (Rx) test kits are Nucleic-Acid Amplification Tests (referred to as NAAT).
  • There is also an opt-in for public health reporting for users who wish to transmit their results to the relevant public health authorities.
  • Lucira is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits.

Lucira Health Announces Expanded Partnership with Switch Health to Increase Canadians' Access to At-Home Molecular COVID-19 Tests

Retrieved on: 
Wednesday, December 22, 2021

Switch Health is a Canadian healthcare company dedicated to providing better decentralized patient care.

Key Points: 
  • Switch Health is a Canadian healthcare company dedicated to providing better decentralized patient care.
  • Switch Health has quickly become a leader in COVID-19 testing on-site at its Switch Health Clinics and at-home through its remote telehealth service and in-person visits.
  • "Lucira has been an instrumental partner in helping Switch Health achieve that in the COVID-19 era.
  • Lucira has received Interim Order authorization from Health Canada to sell and distribute its COVID-19 test kits for at-home self-testing in Canada.

Lucira's at Home Molecular Tests Can Detect Omicron (B.1.1.529) SARS CoV-2 Variant of Concern

Retrieved on: 
Monday, November 29, 2021

Lucira's evaluation of the Omicron variant (B.1.1.529) demonstrated that Lucira's COVID-19 assay can detect 100% of genome sequences of this variant available in the GISAID database as of November 26, 2021.

Key Points: 
  • Lucira's evaluation of the Omicron variant (B.1.1.529) demonstrated that Lucira's COVID-19 assay can detect 100% of genome sequences of this variant available in the GISAID database as of November 26, 2021.
  • The LUCIRA CHECK IT COVID-19 test kit is designed to deliver PCR quality molecular accuracy in 30 minutes or less at home.
  • Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target.
  • The targeted, molecular amplification that LUCIRA CHECK IT and PCR tests employ makes them demonstrably more reliable than "rapid" antigen tests, which can miss active COVID-19 infections.

LUCIRA™ CHECK IT PCR Quality, at Home Molecular COVID-19 Test Kit Now Available on Amazon

Retrieved on: 
Tuesday, November 9, 2021

"We are delighted that our LUCIRA CHECK IT COVID-19 test kit is once again available to Amazon U.S.-customers," said Erik Engelson, Chief Executive Officer.

Key Points: 
  • "We are delighted that our LUCIRA CHECK IT COVID-19 test kit is once again available to Amazon U.S.-customers," said Erik Engelson, Chief Executive Officer.
  • The LUCIRA CHECK IT COVID-19 test kit is designed to deliver PCR quality molecular accuracy in 30 minutes or less at home.
  • Each single-use test kit contains everything needed to conduct one COVID-19 test.
  • The LUCIRA CHECK IT COVID-19 Test Kit (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

LUCIRA™ CHECK IT COVID-19 Test Kit is Available for Online Purchase

Retrieved on: 
Tuesday, October 26, 2021

EMERYVILLE, Calif., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a medical technology company focusing on the development and commercialization of transformative and innovative infectious disease test kits, announced that its LUCIRA™ CHECK IT COVID-19 Test Kit, a self-administered PCR quality, single-use, at home molecular diagnostic test for COVID-19, is again available for online purchase.

Key Points: 
  • We continue to see an increased need for our LUCIRA CHECK IT COVID-19 test kit and reopening our online sales channel via our website allows for greater access to our product.
  • The LUCIRA CHECK IT COVID-19 test kit is designed to deliver PCR quality molecular accuracy in 30 minutes or less at home.
  • Each single-use test kit contains everything needed to conduct one COVID-19 test.
  • The LUCIRA CHECK IT COVID-19 Test Kit (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

DGAP-News: Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19

Retrieved on: 
Wednesday, September 22, 2021

Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19- Preclinical Combination Data Suggests Extra-Ordinary Synergy Between Certain DHODH Inhibitors and Nucleoside Analogues -- Combination of IMU-838 and N4-Hydroxycytidine Reduced SARS-CoV-2 Virus Levels, Including the Delta Variant, Down to the Detection Limit -NEW YORK and GOETTINGEN, Germany, September 22, 2021 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced the execution of an in-license agreement with the University Medical Center Goettingen, Germany, covering the combination of DHODH inhibitors and nucleoside analogues to treat viral infections (COVID-19 and Influenza). Terms of the agreement were not disclosed.
Preclinical research recently completed by the parties and their collaborators[1] has shown that certain DHODH inhibitors, including Immunic's lead asset, IMU-838, strongly synergize with selected nucleoside analogues to inhibit SARS-CoV-2 replication in vitro. For instance, in an in vitro test system, IMU-838 alone showed an up to 99.9% reduction in viral RNA at concentrations of 5 μM, which is well within the exposure levels seen in prior clinical trials. Likewise, N4-hydroxycytidine (NHC), the active metabolite of molnupiravir[2], alone, was associated with an up to 99% reduction in viral RNA at concentrations of 100 nM. Compared to single agent activity, the combination of IMU-838 and NHC achieved an extra-ordinary reduction in viral RNA, down to the limit of detection, reducing SARS-CoV-2 RNA by up to seven log units (corresponding to 0.00001% viral RNA remaining). This powerful reduction of virus replication in vitro was demonstrated across multiple SARS-CoV-2 variants, including alpha, beta and delta, highlighting the independence of this approach to mutant virus forms. In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro. The company plans to present detailed data at an upcoming scientific conference.
"Research by the University Medical Center Goettingen and other research partners revealed a profound degree of synergy in vitro when combining certain nucleoside analogues with DHODH inhibitors, including both our lead asset IMU-838 and other of our preclinical molecules," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Recalling IMU-838's clinical activity against COVID-19 in our phase 2 CALVID-1 trial published earlier this year, and in light of recent exacerbations in COVID-19, worldwide, we are very excited to have in-licensed this technology to incorporate into our pandemic preparedness effort. However, with the extra-ordinary wealth of activity already ongoing at the company in other programs, we intend to evaluate and pursue the best possible strategic option for this program, including potential partnership, collaboration or external funding."

Key Points: 
  • Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19
    The issuer is solely responsible for the content of this announcement.
  • In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro.
  • Matthias Dobbelstein, M.D., Professor of Molecular Oncology, University Medical Center Goettingen, added, "We are proud of the results of our preclinical work.
  • Although the technology in-licensed by Immunic includes the potential combination of DHODH inhibitors with nucleoside analogues, including molnupiravir, Immunic does not have any rights to molnupiravir itself.