Medical tests

Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be Used as a Companion Diagnostic for TABRECTA® (capmatinib)

Retrieved on: 
Friday, July 16, 2021
Medical Supplies, Health, Hospitals, General Health, Pharmaceutical, Biotechnology, Health sciences, Life sciences, Medicine, Orphan drugs, Medical tests, Biostatistics, Companion diagnostic, Medical diagnosis, Novartis, Capmatinib, Foundation Medicine, Medication, FoundationOne Liquid CDx, Foundation Medicine, FOUNDATIONONE LIQUID CDX, FOUNDATION MEDICINE

[2] Today's approval adds to the number of therapies for which both of Foundation Medicines FDA-approved comprehensive genomic tests are listed as companion diagnostics.

Key Points: 
  • [2] Today's approval adds to the number of therapies for which both of Foundation Medicines FDA-approved comprehensive genomic tests are listed as companion diagnostics.
  • FoundationOneCDx, Foundation Medicines tissue test, was approved as a companion diagnostic for TABRECTA in May 2020.
  • TABRECTA is the second therapy for which both of Foundation Medicines FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.
  • Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.
    TABRECTA is a trademark of Novartis.

MCRA Expands In-vitro Diagnostic Device Expertise

Retrieved on: 
Thursday, July 15, 2021
Medical tests, Medical device, MCRA, IVD, Companion diagnostic, Medicine, Clinical medicine, Health sciences

Dr. Mullally served on several senior-level working groups, including the companion diagnostics working group, where he provided input on companion diagnostic device review policy at FDA.

Key Points: 
  • Dr. Mullally served on several senior-level working groups, including the companion diagnostics working group, where he provided input on companion diagnostic device review policy at FDA.
  • About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm.
  • MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally.
  • Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity.

Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Retrieved on: 
Wednesday, July 14, 2021
Medicine, Natural sciences, Branches of biology, Immunologic tests, Medical tests, Medical terminology, Biochemistry methods, COVID-19 testing, Laboratory techniques, Immunoassay, COVID-19, Swab

For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model.

Key Points: 
  • For this study, Curebase converted drive-through COVID-19 testing centers in southern California into clinical research sites with its unique decentralized clinical trial software platform and virtual site support model.
  • This process required no physical interaction with patients and enabled hundreds of people to be screened in a few weeks.
  • The SCoV-2 Ag Detect Rapid Test is a patent-pending lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleoprotein antigen in direct nasal swab specimens.
  • The point-of-care test r equires no instrumentation or transport media step and can be performed on-site with results delivered in about 20 minutes.

New COVID-19 Saliva Test Makes Testing Far Easier for All Ages

Retrieved on: 
Wednesday, July 14, 2021
Medical devices, Infectious diseases, Hospitals, Health, Nursing, Medical tests, Medicine, Clinical medicine, Branches of biology, COVID-19 testing, Saliva testing, Screening

View the full release here: https://www.businesswire.com/news/home/20210714005243/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210714005243/en/
    New COVID-19 saliva test makes testing far easier for all ages.
  • The screening test is performed by inserting the tip of the VSS-GP test strip into the sample, providing a positive or negative result at 20 minutes.
  • (Photo: Business Wire)
    The Intelligent Fingerprinting COVID-19 tests easy saliva sample collection makes it particularly suitable for testing more vulnerable people and children.
  • The introduction of our new COVID-19 test involved rapid design, development and manufacture within the UK over a ten-month period.

Hologic Obtains European CE Mark for Use of Saliva Samples with COVID-19 Test

Retrieved on: 
Wednesday, July 14, 2021
Science, Other Science, Biotechnology, General Health, Health, Medical devices, Infectious diseases, Genetics, Coronaviridae, Sarbecovirus, Zoonoses, Medical tests, Medical genetics, Bat virome, Hologic, Severe acute respiratory syndrome coronavirus, Molecular diagnostics, Severe acute respiratory syndrome, COVID-19

Hologic, Inc. (Nasdaq: HOLX) has obtained a CE Mark for the use of saliva samples with the Aptima SARS-CoV-2 assay in Europe.

Key Points: 
  • Hologic, Inc. (Nasdaq: HOLX) has obtained a CE Mark for the use of saliva samples with the Aptima SARS-CoV-2 assay in Europe.
  • The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19.
  • This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic, said Jan Verstreken, Hologics group president, International.
  • Hologic, The Science of Sure, Aptima, and Panther are registered trademarks of Hologic, Inc. in the United States and/or other countries.

Global Genetic Testing Market Research Report 2021: Market Witnesses Sluggish Growth during COVID-19, Set to Record Exponential Growth Post-COVID - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 13, 2021
Baby, Maternity, Science, Other Science, Consumer, Branches of biology, Clinical medicine, Medicine, Medical genetics, Medical tests, Alternatives to animal testing, Genetic testing, Chromosomal abnormalities, Prenatal testing, Genetic disorder, Chromosome abnormality, Cystic fibrosis

The "Genetic Testing - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Genetic Testing - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • Globally, prenatal testing market is expected to rise due to the increasing risk of chromosomal abnormalities associated with increasing maternal age.
  • One of the key growth drivers for new born and prenatal genetic testing is increased awareness about different chromosomal and genetic disorders.
  • Diagnostic genetic testing detects the presence of a certain genetic disease, like Huntington`s disease or cystic fibrosis through the detection of specific gene alteration.

Quidel Receives CE Mark for Savanna® Multiplex Molecular Analyzer and Respiratory Viral Panel

Retrieved on: 
Monday, July 12, 2021
Data management, Medical devices, Health, Technology, Infectious diseases, General Health, Natural sciences, Branches of biology, Laboratory techniques, Quidel Corporation, Biology, Biotechnology, Medical tests, Molecular biology, the CE Mark, Quidel Corporation, THE CE MARK, QUIDEL CORPORATION

Quidel Corporation (NASDAQ: QDEL) (Quidel), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that the company has received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).

Key Points: 
  • Quidel Corporation (NASDAQ: QDEL) (Quidel), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that the company has received the CE Mark for its innovative Savanna multiplex molecular analyzer and Savanna RVP4 Assay (Respiratory Viral Panel-4).
  • The CE Mark allows Quidel to market and sell the Savanna system in Europe, as well as other countries that accept the CE Mark.
  • The Savanna system is a fully integrated, sample-to-result automated in-vitro diagnostic platform that performs real-time Polymerization Chain Reaction (PCR) tests by using the Savanna instrument and Savanna assay cartridges.
  • Receipt of the CE Mark is an important step forward on our path to commercialize Savannas powerful but simple-to-use molecular diagnostic technology, said Douglas Bryant, president and CEO of Quidel Corporation.

Coronavirus Diagnostics Markets, 2026, By Type of Test (Molecular v/s Serology), By User (Multiple v/s Single), & Full Test Time - ResearchAndMarkets.com

Retrieved on: 
Friday, July 9, 2021
Infectious diseases, Biotechnology, Health, Medical devices, COVID-19, Occupational safety and health, Public health, Zoonoses, Articles, Health, Medical tests

The Global Coronavirus Diagnostics Market was valued at USD73,538.02 million in 2020 and is expected to reach USD15579.56 million by 2026.

Key Points: 
  • The Global Coronavirus Diagnostics Market was valued at USD73,538.02 million in 2020 and is expected to reach USD15579.56 million by 2026.
  • The Global Coronavirus Diagnostics Market is driven by surging incidences of this disease across different parts of the globe.
  • The market is segmented based on type of test, user, full test time, end-user, company and region.
  • Based on type of test, the market can be bifurcated into molecular and serological tests.

US & EU Direct-to-consumer Genetic Testing Market Trends & Growth Opportunities 2021: Genomic Players will have to Transition to Disease-specific Tests, Advanced Kits, Technology & Services - ResearchAndMarkets.com

Retrieved on: 
Friday, July 9, 2021
Retail, Online Retail, Genetics, Health, Medicine, Branches of biology, Clinical medicine, Medical genetics, Medical tests, Alternatives to animal testing, Genetic testing, Medical diagnosis, Prenatal testing, Elective genetic and genomic testing

The "US & EU Direct-to-consumer Genetic Testing Market, Key Trends & Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US & EU Direct-to-consumer Genetic Testing Market, Key Trends & Growth Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • The genomic market is poised to grow at a much faster pace with real-time drug discovery, cutting-edge diagnosis, and technologically advanced treatment.
  • Genomic testing has proven to be a revolutionary tool in medicine, with applications including infectious disease diagnosis, cancer treatment selection, and non-invasive prenatal testing.
  • DTC-GT can be called directly by the consumer at home without any physician recommendation or through healthcare professionals, used for genealogy purposes.

QuantuMDx launches Q-POC™ - rapid PCR point of care diagnostic system

Retrieved on: 
Friday, July 9, 2021
Biotechnology, Branches of biology, Life sciences, Biology, Medical tests, Molecular biology, Laboratory techniques, Hoffmann-La Roche, Polymerase chain reaction, Molecular diagnostics

QuantuMDx Group Limited (QuantuMDx or the Company), a UK-based developer of transformational point-of-care diagnostics, today announces the launch of Q-POC - a rapid, PCR point of care diagnostic system.

Key Points: 
  • QuantuMDx Group Limited (QuantuMDx or the Company), a UK-based developer of transformational point-of-care diagnostics, today announces the launch of Q-POC - a rapid, PCR point of care diagnostic system.
  • Q-POC is a portable PCR system which compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device offering rapid, molecular diagnostic testing at the point of care, with results in approximately 30 minutes.
  • Its a true point of care diagnostic system.
  • For more information about QuantuMDx and Q-POC, its rapid PCR point of care system, go to: www.quantumdx.com.