Medical tests

New Draft Legislation Could Jeopardize Access to Medical Tests Vital to Patient Care

Retrieved on: 
Friday, December 7, 2018
Health, Food and Drug Administration, United States Public Health Service, Laboratory Developed Test, Medicine, Medical tests, American Association for Clinical Chemistry

AACC will oppose this bill if, as in previous iterations, it promotes additional, duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests.

Key Points: 
  • AACC will oppose this bill if, as in previous iterations, it promotes additional, duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests.
  • Laboratory developed tests are created in-house by labs to diagnose rare or new conditions for which no commercial tests exist, such as HIV and SARS when they initially emerged.
  • Test kits and devices developed by medical device manufacturers, on the other hand, are regulated by FDA because they are different and distinct from laboratory developed tests.
  • "We fear that treating clinical laboratories as medical device manufacturers and subjecting them to FDA oversight will force many laboratories to stop offering these tests thus limiting patient access to essential care."

Genomic Health and Biocartis Expand Collaboration to Urology with the Development of an Idylla™ Oncotype DX® Genomic Prostate Score® Test

Retrieved on: 
Monday, December 3, 2018
Medical genetics, RTT, Medicine, Biology, Health, Medical tests, Genomic Health, Molecular diagnostics, Oncotype, Prostate cancer, Breast cancer

The Idylla Oncotype DX GPS test will be the first urology test to be developed on Biocartis' fully- automated, PCR-based Idylla platform, which offers a unique sample-to-result molecular diagnostics solution.

Key Points: 
  • The Idylla Oncotype DX GPS test will be the first urology test to be developed on Biocartis' fully- automated, PCR-based Idylla platform, which offers a unique sample-to-result molecular diagnostics solution.
  • "Today's announcement follows the successful progress in our development of an IVD version of the Oncotype DX Breast Recurrence Score test on Biocartis' Idylla platform, which we announced last year," said Frederic Pla, Ph.D., chief operating officer of Genomic Health.
  • Once available, the Idylla Oncotype DX GPS test can support pathology labs and local urology centers across the world in making better informed treatment decisions for patients with prostate cancer."
  • NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, Oncotype DX AR-V7 Nucleus Detect, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

FDA Approves Expanded Use for Ortho Clinical Diagnostics VITROS® HIV Combo Test

Retrieved on: 
Wednesday, November 28, 2018
Medical tests, Ortho Clinical Diagnostics, Medicine, HIV/AIDS, HIV, Health

RARITAN, N.J., Nov. 28, 2018 /PRNewswire/ --Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) received approval from the U.S. Food and Drug Administration for use on Ortho's VITROS ECi/ECiQ Immunodiagnostic Systems.

Key Points: 
  • RARITAN, N.J., Nov. 28, 2018 /PRNewswire/ --Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) received approval from the U.S. Food and Drug Administration for use on Ortho's VITROS ECi/ECiQ Immunodiagnostic Systems.
  • The VITROS HIV Combo test was previously approved for use on Ortho's VITROS 5600 Integrated System and Ortho's VITROS 3600 Immunodiagnostic System.
  • VITROS HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag).
  • "Ortho is proud to be working to deliver our VITROS HIV Combo test to customers worldwide."

New Study Supports Mammography Screening at 30 for Some Women

Retrieved on: 
Wednesday, November 28, 2018
Medicine, Cancer screening, Cancer, Ribbon symbolism, Clinical medicine, Breast imaging, Mammography, Projectional radiography, Medical tests, Breast cancer screening, Breast cancer, Screening

Some other leading professional groups recommend annual mammography screening beginning at age 40, and RSNA supports this recommendation.

Key Points: 
  • Some other leading professional groups recommend annual mammography screening beginning at age 40, and RSNA supports this recommendation.
  • For the study, Dr. Lee and colleagues compared the performance metrics of screening mammography in women between the ages of 30 and 39 with three specific risk factors versus women, age 40 - 49, without these risk factors, using data from the National Mammography Database (NMD), the largest source of screening mammography outcomes in the U.S.
  • The research team compared screening performance metrics among subgroups of women based on age, risk factors and breast density.
  • "Women with at least one of these three risk factors may benefit from screening mammography beginning at age 30, instead of 40," Dr. Lee said.

SQI Diagnostics to Announce Fourth Quarter and Fiscal 2018 Results

Retrieved on: 
Tuesday, November 27, 2018
Laboratory techniques, Assay, Biochemistry, Titration, Medical tests, Nature, Biology, Laboratory equipment, Molecular diagnostics, Science

SQI Diagnostics is a life sciences and diagnostics company that develops clinical grade multiplexed microarray and molecular assays run on its automated instrumentation for the pharmaceutical research, animal health, and clinical diagnostics markets.

Key Points: 
  • SQI Diagnostics is a life sciences and diagnostics company that develops clinical grade multiplexed microarray and molecular assays run on its automated instrumentation for the pharmaceutical research, animal health, and clinical diagnostics markets.
  • SQI develops custom research and diagnostic assays that are multiplexed; meaning the simplification, consolidation and automation of many individual tests into one.
  • This increases sample throughput, reduces time, cost and chance for human error, and provides excellent data quality.
  • This press release contains certain words and statements, which may constitute "forward-looking statements" within the meaning of applicable securities laws.

My Gene Counsel Expands Genetic Content One Month Into Launch

Retrieved on: 
Tuesday, November 27, 2018
Medicine, Cancer, Breast cancer, Tumor markers, Tumor suppressor genes, Health, Medical genetics, Medical tests, BRCA2, BRCA1, Cancer syndrome, Genetic testing

"If you have had genetic testing using a hereditary cancer gene panel, we now have a report customized for your results," said Ellen Matloff, President and CEO of My Gene Counsel.

Key Points: 
  • "If you have had genetic testing using a hereditary cancer gene panel, we now have a report customized for your results," said Ellen Matloff, President and CEO of My Gene Counsel.
  • Previous My Gene Counsel reports only covered BRCA1 and BRCA2 content.
  • My Gene Counsel plans to expand its reporting to include cardiac, pharmacogenetic and many gene panels offered in the direct-to-consumer marketplace.
  • My Gene Counsel is a HIPAA-compliant digital resource for genetic information and a one-stop-shop to stay on top of advancements tied to personal genetic test results.

MaxQ AI's Accipio™ Software Integrated as Part of GE Healthcare's Smart Subscription Platform Offering in the U.S. and E.U. Acute Care Markets

Retrieved on: 
Tuesday, November 27, 2018
Neurotrauma, Medicine, Stroke, Medical tests, GE Healthcare, Magnetic resonance imaging, Radiopharmaceuticals, General Electric, Intracranial hemorrhage, Intracerebral hemorrhage, CT scan, Head injury

GE Healthcare'sSmart Subscriptionprovides customers with continuous access to the latest imaging software updates, through an available automatic download to their CT scanners from the cloud.

Key Points: 
  • GE Healthcare'sSmart Subscriptionprovides customers with continuous access to the latest imaging software updates, through an available automatic download to their CT scanners from the cloud.
  • As a Smart Subscription offering, hospitals with GE Healthcare CTs can easily and seamlessly integrate MaxQ's Accipio platform, of which Accipio Ix intracranial hemorrhage (ICH) detection software is now available, to support an acute care physician's ability to identify and prioritize brain bleed stroke or head trauma.
  • "Building on our successful collaboration with world-class GE Healthcare, we are pleased that our Accipio intracranial hemorrhage (ICH) detection software has been fully integrated as a function of the Smart Subscription platform," said Gene Saragnese, Chairman and CEO of MaxQ AI.
  • With Smart Subscription, customers can be confident that their GE Healthcare CT scanners will be up to date with the latest imaging software for the life of the system.

Opsens receives Health Canada approval for dPR intended for the diagnosis of coronary stenosis with the heart at rest

Retrieved on: 
Tuesday, November 27, 2018
Circulatory system, Medicine, Cardiology, Coronary artery disease, Medical tests, Instantaneous wave-free ratio

Opsens' dPR has been developed to meet the demand by cardiologists for a way to measure intracoronary pressure with the heart at rest.

Key Points: 
  • Opsens' dPR has been developed to meet the demand by cardiologists for a way to measure intracoronary pressure with the heart at rest.
  • "Accuracy of the pressure measurement becomes even more critical when pressure is measured with the heart at rest.
  • "The approval of Opsens' dPR is a milestone, as it provides us access to a new growing segment of the market.
  • Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcomes of patients with coronary artery disease.

The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%

Retrieved on: 
Monday, November 26, 2018
Biology, Laboratory techniques, Medicine, Chemistry, Blood tests, Cell biology, Clinical pathology, Medical tests, Assay, Flow cytometry, Cytometry, Apoptosis

The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%.

Key Points: 
  • The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%.
  • However, high investments required for research and development is expected to restrain the growth of this market to a certain extent during the forecast period.
  • On the basis of detection technology, the apoptosis assays market is segmented into flow cytometry, cell imaging & microscopy, spectrophotometry, and other detection technologies.The cell imaging & microscopy segment is expected to register the highest CAGR during the forecast period.
  • Firms purchasing the report could use one or any combination of the below-mentioned five strategies for strengthening the market.

The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%

Retrieved on: 
Monday, November 26, 2018
Biology, Laboratory techniques, Medicine, Chemistry, Blood tests, Cell biology, Clinical pathology, Medical tests, Assay, Flow cytometry, Apoptosis, Cytometry

The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%.

Key Points: 
  • The apoptosis assays market is expected to reach USD 5.9 billion by 2023 from an estimated USD 3.6 billion in 2018, at a CAGR of 10.5%.
  • However, high investments required for research and development is expected to restrain the growth of this market to a certain extent during the forecast period.
  • On the basis of detection technology, the apoptosis assays market is segmented into flow cytometry, cell imaging & microscopy, spectrophotometry, and other detection technologies.The cell imaging & microscopy segment is expected to register the highest CAGR during the forecast period.
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