NAAT

Latent Tuberculosis Testing Market Set to Reach $1.96 Billion in 2023 with a CAGR of 5.95% - ResearchAndMarkets.com

Retrieved on: 
Monday, October 23, 2023

Latent tuberculosis, a condition where tuberculosis bacteria remain dormant within the body, presents a unique challenge in healthcare.

Key Points: 
  • Latent tuberculosis, a condition where tuberculosis bacteria remain dormant within the body, presents a unique challenge in healthcare.
  • By Type: The LTBI testing market is segmented into Tuberculin skin test LTBI testing and interferon gamma released assay (IGRA).
  • Geographic Coverage: The global LTBI testing market spans North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
  • The global LTBI testing market features a moderately fragmented landscape, with numerous small- and medium-sized manufacturers contributing significantly.

Cue Health Receives FDA Emergency Use Authorization for Molecular Mpox Test

Retrieved on: 
Monday, March 20, 2023

Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company, today announced it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its molecular test to detect the mpox virus (formerly known as monkeypox).

Key Points: 
  • Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company, today announced it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its molecular test to detect the mpox virus (formerly known as monkeypox).
  • This EUA marks an important milestone for Cue Health, as it is the company’s first non-COVID test to receive FDA authorization, as well as its initial offering in the sexual health category for point-of-care diagnostics.
  • Like all tests developed by Cue, the Cue Mpox Molecular Test was designed with ease-of-use in mind.
  • The company has since submitted an application to the FDA for an EUA for its Cue Flu + COVID-19 Molecular Test.

Europe Monkeypox Testing Market Research Report 2023: An $18.33 Billion Market in 2022 - Industry Outlook and Forecasts to 2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, March 13, 2023

The "Europe Monkeypox Testing Market - Industry Outlook and Forecast 2023-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Monkeypox Testing Market - Industry Outlook and Forecast 2023-2025" report has been added to ResearchAndMarkets.com's offering.
  • The Europe monkeypox testing market was valued at USD 18,330.00 thousand in 2022 and is expected to reach USD 56.10 thousand by 2025.
  • Increasing cases and testing are driving the growth of the Europe monkeypox testing market.
  • The growing product launches of lateral flow assay kits are expected to create lucrative opportunities for the Europe monkeypox testing market growth.

Lucira and Loch Lomond Villa Announce Clinical Study to Tackle Tripledemic With First and Only Combination COVID-19 and Flu OTC Molecular Self-Test

Retrieved on: 
Tuesday, December 6, 2022

“Effective testing is the first line of defense in managing respiratory outbreaks,” said Loch Lomond Villa Chief Executive Officer, Ms. Cindy Donovan.

Key Points: 
  • “Effective testing is the first line of defense in managing respiratory outbreaks,” said Loch Lomond Villa Chief Executive Officer, Ms. Cindy Donovan.
  • The Lucira COVID-19 & Flu Test is a NAAT test utilizing the same platform and device design as Lucira’s COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B.
  • In October of 2019, Loch Lomond Villa was awarded Gold Certification for Excellence in Person-Centered Care by Planetree International.
  • Loch Lomond Villa is one of only 90 healthcare organizations worldwide to receive the Person-Centered Care Gold Certification since the program's launch in 2007.

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

Retrieved on: 
Tuesday, November 29, 2022

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.

Key Points: 
  • 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.
  • View the full release here: https://www.businesswire.com/news/home/20221129005267/en/
    KSL | Pulse Scientific named national distributor in Canada for first-of-its-kind Covid-19 & Flu at-home molecular test.
  • Developed by Lucira Health, this 99% accurate test approved by Health Canada is now available for the COVID/Flu season.
  • Because Australia had an alarming spike in COVID and flu cases and we could see a substantial increase in North America.

Lucira Health Announces FDA Authorization of Combination COVID-19 & Flu Test at Point-of-Care

Retrieved on: 
Tuesday, November 22, 2022

EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Nasdaq: LHDX) ("Lucira Health" or "Lucira"), a medical technology company, announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for its Lucira COVID-19 & Flu Test, for point-of-care use. The Lucira COVID-19 & Flu Test is a molecular test that performed comparably to highly sensitive lab-based PCR assays in clinical trials. This combination test is the first in a pipeline of other multiple assay tests that leverage Lucira technology platform’s ability to multiplex from a single sample. The easy-to-use test delivers results between 11 and 30 minutes from one shallow nasal swab. The Lucira COVID-19 & Flu Test is available for use in CLIA-waived settings and can be purchased online at: www.lucirahealth.com, or email [email protected] for bulk orders.

Key Points: 
  • The Lucira COVID-19 & Flu Test is a molecular test that performed comparably to highly sensitive lab-based PCR assays in clinical trials.
  • The Lucira COVID-19 & Flu Test is available for use in CLIA-waived settings and can be purchased online at: www.lucirahealth.com , or email [email protected] for bulk orders.
  • The Northern Hemisphere is already experiencing a challenging season due to the unprecedented co-circulation of COVID-19, flu and RSV.
  • The Lucira COVID-19 & Flu Test is a NAAT test utilizes the same platform and device design as Lucira's commercialized FDA authorized COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B.

Lucira Health to Announce Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 1, 2022

EMERYVILLE, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Lucira Health or Lucira), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, and a digital health platform that will connect patients with providers, today announced that the company will report third quarter 2022 financial results on, Monday, November 14th, 2022.

Key Points: 
  • EMERYVILLE, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Lucira Health or Lucira), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, and a digital health platform that will connect patients with providers, today announced that the company will report third quarter 2022 financial results on, Monday, November 14th, 2022.
  • ET that day to discuss the financial results and provide a corporate update.
  • Each Lucira test contains everything needed to run a single COVID-19 test: the test device, two AA batteries, sample vial, swab, and simple instructions.
  • Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time.

Lucira Announces Health Canada Authorization of First and Only 99% Accurate At-Home Covid & Flu Test

Retrieved on: 
Thursday, August 11, 2022

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.

Key Points: 
  • 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.
  • Only the Lucira COVID-19 & Flu Test, a single at-home test with 99% accuracy, can answer this question immediately, said Erik Engelson, President and Chief Executive Officer of Lucira Health.
  • We appreciate Health Canada for its careful and thorough assessment of the Lucira COVID-19 & Flu Test.
  • The Lucira COVID-19 & Flu Test is a NAAT test utilizing the same platform and device design as Luciras COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B.

Rite Aid and Quest Diagnostics Expand Access to COVID-19 PCR Testing Nationwide

Retrieved on: 
Tuesday, July 19, 2022

Rite Aid (NYSE: RAD) today announced it is collaborating with Quest Diagnostics (NYSE: DGX) to provide access to quality, COVID-19 molecular testing (polymerase chain reaction or similar nucleic acid amplification test) to help Rite Aid customers detect and prevent the spread of COVID-19.

Key Points: 
  • Rite Aid (NYSE: RAD) today announced it is collaborating with Quest Diagnostics (NYSE: DGX) to provide access to quality, COVID-19 molecular testing (polymerase chain reaction or similar nucleic acid amplification test) to help Rite Aid customers detect and prevent the spread of COVID-19.
  • Quest is the worlds leading provider of diagnostic information services and a national leader in COVID-19 testing.
  • Through the collaboration, Rite Aid and Bartell Drugs more than 2,350 stores, now offer access to Quest PCR testing, either through their drive-thru locations or the addition of at home specimen testing kits from stores without drive-thrus, doubling the access to PCR testing for adults and children over 2 years old.
  • Our relationship with Rite Aid will extend our delivery of COVID-19 testing to more communities in the United States.

Sonic Healthcare USA Announces Testing Availability for Monkeypox

Retrieved on: 
Monday, July 18, 2022

AUSTIN, Texas, July 18, 2022 /PRNewswire/ -- This week, Sonic Healthcare USA (Sonic) began testing for Monkeypox (MPXV), using the Centers for Disease Control and Prevention (CDC) Non-variola Orthopoxvirus, high complexity NAAT (RT-PCR) molecular assay.

Key Points: 
  • AUSTIN, Texas, July 18, 2022 /PRNewswire/ -- This week, Sonic Healthcare USA (Sonic) began testing for Monkeypox (MPXV), using the Centers for Disease Control and Prevention (CDC) Non-variola Orthopoxvirus, high complexity NAAT (RT-PCR) molecular assay.
  • "Being a medically-led organization, Sonic Healthcare USA is uniquely equipped to respond quickly and in close coordination with the CDC to these types of disease outbreaks," said Jerry Hussong, MD, MBA, Chief Executive Officer of Sonic Healthcare USA.
  • Sonic Healthcare USA's Medical and Scientific leaders will continue to monitor the U.S. Monkeypox outbreak and expand testing access.
  • Sonic Healthcare USA is a leading provider of state-of-the-art laboratory and pathology services throughout the USA with eight operating divisions and over eight thousand US based employees.