Medical tests

Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device

Retrieved on: 
Friday, June 11, 2021
Biotechnology, FDA, Health, Medical devices, Medicine, Branches of biology, Clinical medicine, Medical tests, Immunologic tests, Molecular biology, Clinical Laboratory Improvement Amendments, Healthcare in the United States, Surround optical-fiber immunoassay, COVID-19, Severe acute respiratory syndrome, Quidel Corporation

Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy.

Key Points: 
  • Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy.
  • Sales of Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.
  • In addition to the Sofia Q, Quidel offers other rapid diagnostic instrumented systems, including Sofia 2, and Sofia.
  • Quidels Sofia assays for rapid antigen COVID-19 diagnosis include Sofia 2 SARS Antigen FIA and Sofia 2 Flu + SARS Antigen FIA, currently under EUA by the FDA.

Avacta Announces Registration of its AffiDX SARS-CoV-2 Antigen Lateral Flow Test in EU

Retrieved on: 
Friday, June 11, 2021
Oncology, Health, Medical devices, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Branches of biology, Clinical medicine, Medical tests, Biotechnology, Molecular biology, Immunologic tests, Chromatography, Rapid antigen test, Lateral flow test, Severe acute respiratory syndrome, Polymerase chain reaction

Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.

Key Points: 
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • The product registration by a Competent Authority in the EU allows the Company to sell the product in the EU for professional use.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU.

USA Swimming Partners with BD to Provide COVID-19 Screening for the Olympic Trials and Other Competitive Swimming Events

Retrieved on: 
Friday, June 11, 2021
Life sciences, Natural sciences, Biology, Biotechnology, Molecular biology, Medical tests, Medical terminology, Chromatography, Rapid antigen test, Polymerase chain reaction, BD

These tests will also be utilized at 2021-2022 USA Swimming events where testing is required.

Key Points: 
  • These tests will also be utilized at 2021-2022 USA Swimming events where testing is required.
  • "USA Swimming has prioritized athlete health and safety during this competitive season, emphasizing COVID-19 risk mitigation procedures," USA Swimming Director of Sports Medicine and Science Keenan Robinson said.
  • "BD's rapid antigen test, combined with a PCR test, will ensure accurate testing, helping keep everyone involved at USA Swimming safe and in the water."
  • Throughout the course of the U.S. Olympic Team Trials Swimming, more than 2,000 tests using the BD Veritor Plus System will be administered.

Entheon Biomedical's Wholly-Owned Subsidiary, HaluGen Life Sciences, Psychedelics Genetic Test Kit Now Available for Sale in US

Retrieved on: 
Thursday, June 10, 2021
Medicine, Hallucinations, Clinical medicine, Medical tests, Branches of biology, Psychedelic drug, Genetic testing

HaluGen Life Sciences' test evaluates an individual's overall sensitivity and risk profile associated with psychedelic-assisted therapy

Key Points: 
  • The Psychedelics Genetic Test Kit, a first of its kind, was designed and commercialized by HaluGen, and launched in Canada on April 5, 2021.
  • The Psychedelics Genetic Test Kit provides users with personalized reports and actionable insights, delivered directly to one's smartphone or desktop through the HaluGen website customer platform, providing a convenient and safe means to better understand one's sensitivity to psychedelics and ketamine.
  • The test also provides insights into the short and long-term potential of psychedelic-induced risks, such as psychosis.
  • Psychedelics Genetic Test Kit customers receive a swab kit that is shipped directly to their home and the unique kit identifier is registered on HaluGen's secure online portal.

GO2 Foundation for Lung Cancer Expands Early Detection Efforts to Include Incidental Pulmonary Nodules (IPN) to Save More Lives

Retrieved on: 
Thursday, June 10, 2021
Medicine, Medical tests, Medical terminology, Lung cancer, Screening, Cancer, Health

SAN CARLOS, Calif. and WASHINGTON, June 10, 2021 /PRNewswire/ --To help diagnose early-stage lung cancer when it is more treatable and even curable, GO2 Foundation for Lung Cancer (GO2 Foundation) is expanding its early detection efforts to include incidental pulmonary nodule (IPN) management.

Key Points: 
  • SAN CARLOS, Calif. and WASHINGTON, June 10, 2021 /PRNewswire/ --To help diagnose early-stage lung cancer when it is more treatable and even curable, GO2 Foundation for Lung Cancer (GO2 Foundation) is expanding its early detection efforts to include incidental pulmonary nodule (IPN) management.
  • GO2 Foundation is prioritizing this work to identify and track suspicious nodules and malignancies alongside existing screening efforts, further advancing early detection for even more people.
  • "GO2 Foundation's new IPN initiative will give health care providers additional tools to diagnose lung cancer early, when it's more treatable and even curable."
  • The goal is the early detection of a lung cancer whether identified though screening or a robust IPN program."

Castle Biosciences Announces Receipt of New York Laboratory Permit

Retrieved on: 
Wednesday, June 9, 2021
Research, Medical devices, Genetics, Other Health, Biotechnology, General Health, Health, Science, Oncology, Other Science, Medicine, Branches of biology, Health care, Clinical Laboratory Improvement Amendments, Healthcare in the United States, Medical laboratory, College of American Pathologists, Medical tests, DecisionDx-SCC, Castle Biosciences, DECISIONDX-SCC, CASTLE BIOSCIENCES

With the expansion of our New York Clinical Laboratory Permit to include our DecisionDx-SCC test, patients in New York will now have access to personalized genomic information, which physicians can use to make more informed choices for patients treatment and follow-up care, said Kristen Oelschlager, chief operating officer of Castle Biosciences.

Key Points: 
  • With the expansion of our New York Clinical Laboratory Permit to include our DecisionDx-SCC test, patients in New York will now have access to personalized genomic information, which physicians can use to make more informed choices for patients treatment and follow-up care, said Kristen Oelschlager, chief operating officer of Castle Biosciences.
  • The approval process in New York is rigorous and includes both a physical laboratory inspection and an extensive review of the tests validation data.
  • Castles laboratory operations are located in Phoenix, and in 2020, the Company doubled the footprint of its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified primary laboratory facility.
  • Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix.

LivFul and Global Access Diagnostics announce partnership for COVID-19 test kit distribution

Retrieved on: 
Wednesday, June 9, 2021
Medicine, Medical tests, Branches of biology, Clinical medicine, Medical terminology, Immunologic tests, Chromatography, Molecular biology, Rapid antigen test, COVID-19 rapid antigen test, Point-of-care testing

LIVERPOOL, England, June 9, 2021 /PRNewswire/ --LivFul and Global Access Diagnostics (GAD)today announced a new partnership to make a variety of diagnostic kits, starting with COVID-19 rapid antigen tests, available in Low to Middle Income Countries.

Key Points: 
  • LIVERPOOL, England, June 9, 2021 /PRNewswire/ --LivFul and Global Access Diagnostics (GAD)today announced a new partnership to make a variety of diagnostic kits, starting with COVID-19 rapid antigen tests, available in Low to Middle Income Countries.
  • This partnership will bring rapid antigen test kits to the market at an affordable price.
  • We are aligned in driving access to our COVID-19 antigen test for as many people as possible."
  • "LivFul was founded to expand health access with products that transform lives and business models that reach all people.

Magnetic Resonance Imaging (MRI) Provides Certain Advantages Compared to Computed Tomography (CT) Technology

Retrieved on: 
Tuesday, June 8, 2021
Radiology, Medicine, Medical imaging, Clinical medicine, Nuclear medicine, Medical physics, Medical tests, Magnetic resonance imaging, Tomography, CT scan, Cardiac imaging, Neuroimaging

SARASOTA, Fla., June 8, 2021 /PRNewswire/ -- Peter Solodko, CEO of A1 Medical Imaging with Open MRI centers in Florida and Georgia, explains the advantages of magnetic resonance imaging (MRI) compared to computed tomography (CT) when it comes to obtaining detailed images of the inside of the human body.

Key Points: 
  • SARASOTA, Fla., June 8, 2021 /PRNewswire/ -- Peter Solodko, CEO of A1 Medical Imaging with Open MRI centers in Florida and Georgia, explains the advantages of magnetic resonance imaging (MRI) compared to computed tomography (CT) when it comes to obtaining detailed images of the inside of the human body.
  • "Computerized tomography uses computers and rotating X-ray emissions to create cross-sectional images of the internal anatomy," Solodko said.
  • "Magnetic resonance imaging is a non-invasive technology that uses magnets, radio waves, and computers to obtain more detailed pictures of a patient's anatomy than CT," Peter Solodko stated.
  • "All of our A1 Medical Imaging centers utilize an open MRI design to reduce the sense of confinement and claustrophobia."

Recent Changes in Drug-testing Practices Transform How Employers Hire

Retrieved on: 
Tuesday, June 8, 2021
Appetite stimulants, Entheogens, Euphoriants, Drugs, Psychoactive drugs, Clinical medicine, Cannabis, Medical tests, Drug test, Tetrahydrocannabinol

DENVER, June 8, 2021 /PRNewswire/ --Last week, one of the world's largest employers announced that they are pulling THC from their pre-employment drug screening program.

Key Points: 
  • DENVER, June 8, 2021 /PRNewswire/ --Last week, one of the world's largest employers announced that they are pulling THC from their pre-employment drug screening program.
  • While the repercussions have yet to fully unfold, companies who compete for employees in the same labor pool are on high alert.
  • Removing pre-employment drug screening for marijuana is one less hurdle for those who are actively looking for jobs.
  • Traditional drug testing for THC, the psychoactive metabolite identified through mainstream testing methods, has been under fire for several years.

ERT Announces Real-Time Coaching for Pulmonary Function Tests Performed in the Patient's Home

Retrieved on: 
Tuesday, June 8, 2021
Respiratory therapy, Clinical medicine, Health care, Medicine, ERT, Medical tests, Pulmonary function testing, Spirometry

PHILADELPHIA, June 8, 2021 /PRNewswire/ -- ERT , the global leader in data collection for clinical endpoints, today announced the launch of ERT iSpiro Virtual Visits, which enables real-time coaching during at-home pulmonary function tests (PFT).

Key Points: 
  • PHILADELPHIA, June 8, 2021 /PRNewswire/ -- ERT , the global leader in data collection for clinical endpoints, today announced the launch of ERT iSpiro Virtual Visits, which enables real-time coaching during at-home pulmonary function tests (PFT).
  • With iSpiro Virtual Visits, ERT delivers on its commitment to provide customer and patient-oriented innovations that facilitate decentralization.
  • "Performing spirometry correctly can be critical to the success of a drug approval," said Achim Schlke, Executive Vice President of ERT Respiratory Solutions.
  • By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly and with confidence.