Medical tests

Qorvo Biotechnologies Omnia™ SARS-CoV-2 Antigen Test Platform Validated in National Institutes of Health (NIH) Funded Study

Wednesday, July 28, 2021 - 9:01pm

Atlantas Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test.

Key Points: 
  • Atlantas Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test.
  • Three pediatric samples that tested negative on the Qorvo Omnia Antigen Test had Cycle threshold (Ct) values greater than 38 on the Hologic system, indicating very low viral loads in those samples.
  • Overall, the investigators found the Qorvo Omnia platform design intuitive and easy to use while producing rapid test results compared to high-sensitivity molecular testing systems, with test results within 20 minutes from sample collection.
  • This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health.

iXensor Levels Up PixoTest Covid-19 Ag Test With The Launch Of PixoHealth Data Management Platform As The Security Solution For The New Normalcy

Tuesday, July 27, 2021 - 12:32pm

In addition, the PixoHealth Pass Admin Web Portal synchronizes multi-source COVID-19 related health data and rapid test results from PixoHealth Pass App users and PixoTest POCT Analyzer simultaneously.

Key Points: 
  • In addition, the PixoHealth Pass Admin Web Portal synchronizes multi-source COVID-19 related health data and rapid test results from PixoHealth Pass App users and PixoTest POCT Analyzer simultaneously.
  • The utilization of PixoHealth Pass Admin Web Portal, PixoTest POCT Analyzer and PixoHealth Pass App fully digitizes the data management processes with a one-time setup.
  • In addition, PixoHealth Pass Admin App allows organizations to configure health-data based access management rules for keeping SARS-CoV-2 from causing cluster infections.
  • In 2017, iXensor introduced the PixoTest Blood Glucose Monitoring System as the world's first US FDA-approved smartphone camera-based blood test.

Global WholeHealth Partners Corp.'s (OTC: GWHP) Antibody IgG/IgM and Antigen Tests That They Offer Are Capable of Detecting the DELTA B.1.617.2, United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) of COVID 19 SARS 2

Monday, July 26, 2021 - 12:00pm

Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM and Antigen tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.

Key Points: 
  • Global WholeHealth Partners Corp (OTC: GWHP) states that the Antibody IgG/IgM and Antigen tests that they offer are capable of detecting all the current identified SARS-CoV-2 viruses.
  • The government is working with the diagnostics industry to ensure the gains in domestic manufacturing are not lost over time.
  • To conquer COVID and win this war, Global must keep up the research and development of tests.
  • Global WholeHealth Partners recognizes that there is a crucial need for faster testing and faster results when it comes to fighting the COVID.

CityHealth Launches RapidReturn COVID-19 Travel Kit

Monday, July 26, 2021 - 9:40pm

The RapidReturn Kit allows US-bound travelers to take a supervised Rapid Antigen test and receive travel-approved results from anywhere in the world.

Key Points: 
  • The RapidReturn Kit allows US-bound travelers to take a supervised Rapid Antigen test and receive travel-approved results from anywhere in the world.
  • Priced at just $75 per kit, each kit contains 2 tests.
  • One kit per traveler is recommended, so travelers are prepared for flight delays or inconclusive results that require a second test.
  • CityHealth's RapidReturn Kit is one of the most affordable and user-friendly pre-travel COVID test kits on the market.

Ortho Clinical Diagnostics to Report Second Quarter 2021 Results on August 4, 2021

Friday, July 23, 2021 - 2:00pm

RARITAN, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Ortho Clinical Diagnostics (Nasdaq: OCDX), one of the worlds largest pure-play in vitro diagnostics companies, today announced it will report results for its second quarter 2021 ended July 4, 2021, after the market close on Wednesday, August 4, 2021.

Key Points: 
  • RARITAN, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Ortho Clinical Diagnostics (Nasdaq: OCDX), one of the worlds largest pure-play in vitro diagnostics companies, today announced it will report results for its second quarter 2021 ended July 4, 2021, after the market close on Wednesday, August 4, 2021.
  • Ortho Clinical Diagnostics will hold a conference call the same day at 5:00 pm ET to discuss the results.
  • Interested parties can access the call and accompanying presentation on the Investors portion of the Companys website at https://ir.orthoclinicaldiagnostics.com/ .
  • Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the worlds largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care.

2021 Worldwide Molecular Diagnostics Tests Market Report: 10th Edition - ResearchAndMarkets.com

Friday, July 23, 2021 - 3:35pm

Clinical molecular tests available for infectious disease testing offer a combination of high sensitivity, specificity and low turnaround time advantages.

Key Points: 
  • Clinical molecular tests available for infectious disease testing offer a combination of high sensitivity, specificity and low turnaround time advantages.
  • This report reviews the current makeup of the molecular diagnostics market in cancer, including its notable products and geographical segmentation.
  • The current market is largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types.
  • World Molecular Diagnostics Market analyzes the developments in most significant markets within molecular inherited disease diagnostics.

Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid(TM) Clinical Study Test Results

Thursday, July 22, 2021 - 2:24pm

Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.

Key Points: 
  • Negative percent agreement (NPA) is the proportion of comparative/reference method negative results in which the test method result is negative.
  • "We're excited to share our overall 264 test results from our Brazilian AcuVid Saliva / RT-PCR Test Clinical Study.
  • The additional 201 test results, on top of the initial 63, not only exceed FDA-EUA minimum requirements, but confirms the performance quality and ease-of-use of our AcuVid saliva test.
  • In fact, our complete AcuVid study achieved comparable, and in some cases, better performance results than other leading COVID-19 rapid antigen tests available on today's market," expressed Rob Fia, CEO of Therma Bright.

Covid-19 Tests Innovations Drawing New Interest from FDA and Consortiums

Thursday, July 22, 2021 - 5:45pm

For many establishments, the tests help to assess levels of risk for patrons, employees and other interested parties.

Key Points: 
  • For many establishments, the tests help to assess levels of risk for patrons, employees and other interested parties.
  • Now the FDA has released guidance to BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV) for its T-cell immune response diagnostic platform CoviDTH to begin Phase I/II Clinicial Trials.
  • However, later in July, Abbott was reported to be working to import the PanBio Covid-19 self tests from Korea.
  • The Sofia test was the first rapid antigen test to get an FDA greenlight , back in May of last year.

Covid-19 Tests Innovations Drawing New Interest from FDA and Consortiums

Thursday, July 22, 2021 - 5:45pm

VANCOUVER, B.C., July 22, 2021 /PRNewswire/ -- USA News Group  -  Two of the world's most prominent billionaires, George Soros and Bill Gates, recently made headlines backing a consortium to buy UK Covid-19 test maker Mologic for $41 million ahead of a new initiative of a global rollout for rapid result testing. As demand shifts, newer innovations from not only from Mologic are gaining attention, including a new T-Cell Immune Response diagnostic from BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), antigen tests from Abbott Laboratories (NYSE: ABT), Chembio Diagnostics, Inc. (NASDAQ: CEMI) and Quidel Corporation (NASDAQ: QDEL), and antibody tests from Ortho Clinical Diagnostics Holdings plc (NASDAQ: OCDX).

Key Points: 
  • For many establishments, the tests help to assess levels of risk for patrons, employees and other interested parties.
  • Now the FDA has released guidance to BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV) for its T-cell immune response diagnostic platform CoviDTH to begin Phase I/II Clinicial Trials.
  • However, later in July, Abbott was reported to be working to import the PanBio Covid-19 self tests from Korea.
  • The Sofia test was the first rapid antigen test to get an FDA greenlight , back in May of last year.

Co-Diagnostics, Inc. Strengthens Intellectual Property Portfolio with New International CoPrimer™ Patent

Thursday, July 22, 2021 - 2:30pm

SALT LAKE CITY, July 22, 2021  /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it has added to its suite of intellectual property protection after being awarded a patent from the Republic of Korea's Intellectual Property Office for the Company's CoPrimer™ technology.

Key Points: 
  • The test was also recently utilized in several international peer-reviewed papers
    "We believe that this patent granted by South Korea provides additional validation of the uniqueness and versatility of the CoPrimer platform," remarked Dwight Egan, Chief Executive Officer of Co-Diagnostics.
  • "Our durable business model of selling tests to United States CLIA labs and their international equivalents continues to drive strong sales.
  • Importantly, CoPrimer technology is also used in the products manufactured and marketed by CoSara Diagnostics, our Joint Venture in India.
  • Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures, and markets a state-of-the-art diagnostics technology.