PCR

Mainz Biomed Provides U.S. Regulatory Review Update for ColoAlert

Retrieved on: 
Wednesday, February 23, 2022
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BERKELEY, Calif. and MAINZ, Germany, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (Mainz Biomed or the Company), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that its pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review.

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (Mainz Biomed or the Company), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that its pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review.
  • Mainz is currently marketing ColoAlert through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
  • ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*.
  • Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates.

USPTO Issues Two Patents for a Daily Screening Solution for COVID-19 and Other Infections

Retrieved on: 
Tuesday, February 22, 2022
GLOBE, PCR, Patent, Personal, Organization, COVID-19, Fever, Invention, USPTO, Department of Defense Instruction 1300.28, I-3, Temperature, DARPA, PWT, United States Military Academy, Person, CEO, Infection, Department, Pharmaceutical industry, Vaccine

PWT uses daily monitoring to compute a person's unique range of normal body temperature and flag abnormalities that indicate infections such as COVID-19.

Key Points: 
  • PWT uses daily monitoring to compute a person's unique range of normal body temperature and flag abnormalities that indicate infections such as COVID-19.
  • PWT is more accurate than the U.S. Government fever standard of 100.4F (38C).
  • The PWT system uses a website to help users monitor their own temperature measurements, typically taken at home.
  • Most people can have anomalous temperatures as low as 99F.Quite simply, PWT is a game-changer in the long-term fight against COVID-19."

XpresCheck® Opens Second COVID-19 Testing Facility at Denver International Airport

Retrieved on: 
Tuesday, February 22, 2022
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DENVER, Feb. 22, 2022 (GLOBE NEWSWIRE) -- XpresSpa Group, Inc. (Nasdaq: XSPA) (XpresSpa or the Company), a health and wellness company, today announced that it has opened a second XpresCheck COVID-19 testing facility at Denver International Airport (DEN).

Key Points: 
  • DENVER, Feb. 22, 2022 (GLOBE NEWSWIRE) -- XpresSpa Group, Inc. (Nasdaq: XSPA) (XpresSpa or the Company), a health and wellness company, today announced that it has opened a second XpresCheck COVID-19 testing facility at Denver International Airport (DEN).
  • Scott Milford, XpresSpa Group CEO, said, "We are thrilled to open our second testing facility inDenver.
  • This new testing facility is pre-security, so passengers traveling through DEN will now have greater access to testing options so that they can meet the entry requirements of their final destination.
  • XpresCheck is a leading on-site airport provider of COVID-19 screening and testing with 15 locations in 12 domestic airports.

QuantuMDx announces approval of its Rapid Q-POCTM SARS-CoV-2 assay in the UK under CTDA legislation

Retrieved on: 
Tuesday, February 22, 2022
COVID-19, Financial adviser, TPP, PCR, TVG, Omicron, Marketing communications, Pharmacy, POC, Hospital, UPON, Dentistry, Interview, Genome, The Health Protection (Coronavirus, Restrictions) (All Tiers and Self-Isolation) (England) (Amendment) Regulations 2021, Company, Medtech, Security, Disease, UK Health Security Agency, STI, Point, Severe acute respiratory syndrome coronavirus 2, Patient, CT, Medical device

QuantuMDx Group Limited (QuantuMDx), today announces that its rapid PCR SARS-CoV-2 test, with the multiplex Q-POC platform, has been approved for continued sales in the UK under the UK Health Security Agencys Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).

Key Points: 
  • QuantuMDx Group Limited (QuantuMDx), today announces that its rapid PCR SARS-CoV-2 test, with the multiplex Q-POC platform, has been approved for continued sales in the UK under the UK Health Security Agencys Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).
  • It was noted within the report that there were a high proportion of patients with a CT over 30 which may affect the overall sensitivity.
  • Q-POC and its first test, a SARS-CoV-2 detection assay , are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe.
  • For more information about QuantuMDx and Q-POC, its rapid PCR point of care system, go to: www.quantumdx.com .

Element Biosciences Partners with New England Biolabs® to Launch New NEBNext® Ultra™ II Kits Specifically Designed for the Element AVITI™ System

Retrieved on: 
Tuesday, February 22, 2022
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Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a partnership with New England Biolabs (NEB) to commercially develop and launch products to enable compatibility of the NEBNext Ultra II portfolio with the Element AVITI System.

Key Points: 
  • Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a partnership with New England Biolabs (NEB) to commercially develop and launch products to enable compatibility of the NEBNext Ultra II portfolio with the Element AVITI System.
  • We are excited about the partnership with NEB and very proud of the new NEBNext Ultra II workflows developed specifically for Element Bioscience customers.
  • NEW ENGLAND BIOLABS, NEB and NEBNEXT are registered trademarks of New England Biolabs, Inc.
  • Element Biosciences is a multi-disciplinary life science company currently focused on developing disruptive DNA sequencing technology for research and diagnostic markets.

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

Retrieved on: 
Wednesday, February 23, 2022
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In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space.

Key Points: 
  • In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space.
  • The COVID-19 portfolio adds to the infectious diseases menu - HIV-1, HBV, HCV, HIV-1/HIV-2 Qualitative - and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark launched in December 2021.
  • The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems.
  • Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, through early-to-mid 2022.

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

Retrieved on: 
Wednesday, February 23, 2022
HCV, Central nervous system, Dow Jones, PCR, Joint Medical Service (Germany), LIS, DJSI, RNA, Diagnosis, COVID-19, Ophthalmology, HBV, Influenza B virus, Laboratory, World, Heart, Influenza, Pharmaceutical industry, List, CHF, Utility, Roche Diagnostics, Severe acute respiratory syndrome coronavirus 2, Essential medicines, Infection, HIV-1, RO, Genentech, Influenza A virus, CE marking, Patient, Automation, Hoffmann-La Roche, Solution, ROG, CE, Time, Vaccine, Fine chemical, Medical imaging, System, Chugai Pharmaceutical Co.

PLEASANTON, Calif., Feb. 23, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of the COVID-19 PCR portfolio to the cobasⓇ 5800 System, a recently launched molecular laboratory instrument, in countries accepting the CE mark. These include cobas SARS-CoV-2 Qualitative and cobas SARS-CoV-2 & Influenza A/B tests. These launches expand the Roche Diagnostics molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs. In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space. This means better access to testing in countries or environments where there isn't enough space or resources to accommodate larger instruments.

Key Points: 
  • In addition, the new compact cobas 5800 System broadens access for healthcare systems with limited resources or space.
  • The COVID-19 portfolio adds to the infectious diseases menu - HIV-1, HBV, HCV, HIV-1/HIV-2 Qualitative - and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark launched in December 2021.
  • The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems.
  • Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, through early-to-mid 2022.

Top Private Lab Opens New Lincoln COVID-19 Testing Location as Omicron Spreads

Retrieved on: 
Tuesday, February 22, 2022
Omicron, PCR, Insurance, Mouth, LAMP, COVID-19, Quarantine, Laboratory, Safety, Travel, Nose, Patient, COVID, Infection, Animal, Vaccine, Ridesharing company, Lincoln

LINCOLN, Neb., Feb. 22, 2022 /PRNewswire/ --With the Omicron variant of COVID-19 still spreading in the community, one of the largest private testing laboratories in the nation is opening a new testing location in Lincoln.

Key Points: 
  • LINCOLN, Neb., Feb. 22, 2022 /PRNewswire/ --With the Omicron variant of COVID-19 still spreading in the community, one of the largest private testing laboratories in the nation is opening a new testing location in Lincoln.
  • So far this year, the company has performed nearly 235,000 rapid antigen tests nationally.
  • "Testing remains an important part of our nation's response to the COVID-19 pandemic," said Dr. Darin Jackson, GS Labs Medical Director.
  • "Our tests provide customers with quick answers to make the right health care decisions for themselves and their loved ones."

Top Private Lab Opens 3rd Portland-Area COVID-19 Testing Site

Retrieved on: 
Tuesday, February 22, 2022
PCR, Omicron, Insurance, SE, Mouth, LAMP, COVID-19, Quarantine, Safety, Travel, Nose, Parkway, Patient, COVID, Infection, Gypsum, Vaccine, Ridesharing company

The new testing site is the third Portland location operated by GS Labs.

Key Points: 
  • The new testing site is the third Portland location operated by GS Labs.
  • Having recently tested its millionth patient, GS Labs, headquartered in Omaha, is a leading provider of COVID-19 rapid antigen tests in Oregon and across the nation.
  • "COVID testing remains an important way to help contain infections," said Dr. Darin Jackson, GS Labs Medical Director.
  • Even if your test is negative, it's wise to reduce non-essential activities for a full seven days after travel.

Re-Entry Testing Requirement Still in Place - How Travel Insurance Covers Quarantine Costs

Retrieved on: 
Tuesday, February 22, 2022
Entrepreneurship, Transport, Yonder, Travel, PCR, Insurance, NOT, Government, COVID-19, Quarantine, Medicine, Meal, Policy, Tourism, Health insurance

MINNEAPOLIS, Feb. 22, 2022 /PRNewswire/ -- As destinations ease restrictions and travelers consider international travel for the first time since the pandemic, the re-entry testing requirement remains in place.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2022 /PRNewswire/ -- As destinations ease restrictions and travelers consider international travel for the first time since the pandemic, the re-entry testing requirement remains in place.
  • Travel insurance will help you book with peace of mind knowing that unexpected costs may be covered if you contract COVID-19 while at your destination.
  • The experts at Yonder Travel Insurance break down how travel insurance covers quarantine (or not!)
  • "Most resorts now have quarantine plans in place if a guest tests positive for COVID-19," says Terry Boynton, President and Co-Founder at Yonder.