Sensitivity and specificity

Copan Colibrí™ Receives Third FDA Clearance, Further Expanding Automated ID/AST Workup Capabilities

Retrieved on: 
Tuesday, January 30, 2024

The automated ID/AST preparation instrument is a key component in Copan's full laboratory automation line that revolutionizes the workflow and efficiency of microbiology labs.

Key Points: 
  • The automated ID/AST preparation instrument is a key component in Copan's full laboratory automation line that revolutionizes the workflow and efficiency of microbiology labs.
  • The Colibrí™ system is a fully automated specimen preparation platform designed to prepare MALDI-TOF ID targets and create bacterial suspensions for Antibiotic Susceptibility Testing (AST).
  • The latest FDA clearance recognizes the ability of the Colibrí™ instrument to seamlessly integrate with the Beckman Coulter MicroScan Walkaway Instruments & Panels for ID/AST.
  • Later that year the Colibri™ system received FDA 510(k) clearance for use with bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing System.

Additional Results of POSLUMA® (Flotufolastat F 18) Performance in Newly Diagnosed, High-risk Prostate Cancer Patients Presented at ASTRO

Retrieved on: 
Tuesday, October 3, 2023

Specifically, this sub-group examined the performance of flotufolastat F 18 PET in newly diagnosed, high-risk prostate cancer patients who had negative results with conventional imaging.

Key Points: 
  • Specifically, this sub-group examined the performance of flotufolastat F 18 PET in newly diagnosed, high-risk prostate cancer patients who had negative results with conventional imaging.
  • The detection rate for M1 lesions (lesions that have spread beyond the pelvic area) for flotufolastat F 18 in 197 patients was 14% - 25% across the 3 readers.
  • “The demonstrated performance of PSMA-PET imaging fits an important unmet need, given that conventional imaging techniques are limited in the information they provide.
  • Full session details and the abstract are available in the ASTRO online program here .

Study Confirms DISCERN™ Alzheimer’s Disease Diagnostic Projected to Save Nearly $5 Million Over Three Years for Medicare Advantage Plans, Avoids Inappropriate Prescribing of New, Expensive Medications

Retrieved on: 
Thursday, June 1, 2023

Results from the study show the DISCERN test, the only autopsy-validated skin test to detect AD, even in people recently diagnosed with dementia, can save nearly $5 million in just three years for a Medicare Advantage plan with one million beneficiaries.

Key Points: 
  • Results from the study show the DISCERN test, the only autopsy-validated skin test to detect AD, even in people recently diagnosed with dementia, can save nearly $5 million in just three years for a Medicare Advantage plan with one million beneficiaries.
  • “Ensuring patients receive accurate diagnoses is of growing urgency as upcoming AD drugs elicit safety concerns and rising costs for the US.
  • Considering the newly available anti-amyloid drugs, improving diagnostic accuracy in the community setting will likely increase the cost savings to the plans.
  • This becomes even more problematic when evaluating treatment options for patients in the early stages of dementia or mild cognitive impairment (MCI).

Blue Earth Diagnostics Announces Additional Results from Phase 3 LIGHTHOUSE Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer

Retrieved on: 
Thursday, February 16, 2023

Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced additional results from its Phase 3 LIGHTHOUSE trial that evaluated the diagnostic performance and safety of 18F-rhPSMA-7.3 in newly diagnosed prostate cancer.

Key Points: 
  • Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced additional results from its Phase 3 LIGHTHOUSE trial that evaluated the diagnostic performance and safety of 18F-rhPSMA-7.3 in newly diagnosed prostate cancer.
  • 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent.
  • Men with treatment-naïve, unfavorable intermediate to very high-risk prostate cancer who were scheduled to undergo radical prostatectomy and PLND underwent PET imaging after administration of 18F-rhPSMA-7.3.
  • The LIGHTHOUSE Phase 3 clinical trial ( NC04186819 ) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in men with newly diagnosed prostate cancer.

SYNAPS Dx Releases Positive Budget Impact Results for DISCERNTM at International Conference on Aging Diseases and Elderly Care: Alzheimer’s Disease Diagnostic Projected to Save $4+ Million in Three Years

Retrieved on: 
Tuesday, December 13, 2022

Results show the DISCERN test can save over $4 million in just three years for a Medicare Advantage plan with one million beneficiaries.

Key Points: 
  • Results show the DISCERN test can save over $4 million in just three years for a Medicare Advantage plan with one million beneficiaries.
  • The DISCERN test is the first and only diagnostic skin test that supports a clinicians definitive diagnosis of AD, even in people recently diagnosed with dementia.
  • DISCERN supports an accurate, definitive diagnosis of AD earlier in the disease and may generate savings for Medicare Advantage plans.
  • SYNAPS Dx is a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimers disease (AD).

Professor Romney Humphries Joins Next Gen Diagnostics Scientific Advisory Board

Retrieved on: 
Thursday, September 22, 2022

WEST PALM BEACH, Fla., Sept. 22, 2022 /PRNewswire-PRWeb/ -- Next Gen Diagnostics announces that Vanderbilt Professor Romney M. Humphries has joined its Scientific Advisory Board. Dr. Humphries is a national leader in antibiotic susceptibility determination, its regulatory approval and clinical application, is the section director of clinical microbiology at Vanderbilt University Medical Center, and was a Scientific Advisory Board member of Specific Diagnostics before its sale to bioMerieux in May 2022. Dr. Humphries' work correlating the genomic basis of resistance to in vitro susceptibility results along with her deep experience in regulatory clearance requirements will provide invaluable insight as NGD systematically brings whole genome sequence (WGS)-based diagnostics to patient care under the FDA regulatory framework.

Key Points: 
  • Professor Romney Humphries, National Leader in Antibiotic Susceptibility Testing, Has Joined Next Gen Diagnostics Scientific Advisory Board
    WEST PALM BEACH, Fla., Sept. 22, 2022 /PRNewswire-PRWeb/ -- Next Gen Diagnostics announces that Vanderbilt Professor Romney M. Humphries has joined its Scientific Advisory Board.
  • Dr. Humphries is a national leader in antibiotic susceptibility determination, its regulatory approval and clinical application, is the section director of clinical microbiology at Vanderbilt University Medical Center, and was a Scientific Advisory Board member of Specific Diagnostics before its sale to bioMerieux in May 2022.
  • "I am pleased to join NGD's Scientific Advisory Board just as the field is nearing the transformative moment when pathogen sequence will start to become utilized for making decisions about patient care," said Dr. Humphries.
  • "I am gratified that Romney will join NGD's distinguished Scientific Advisory Board," said Dr. Paul A. Rhodes, CEO.

EmeritusDX Announces Launch of UTIDX™ to Advance Patient Care in Urology

Retrieved on: 
Friday, January 28, 2022

"We are proud to launch UTIDX and feel strongly about the value this test will bring to our clients.

Key Points: 
  • "We are proud to launch UTIDX and feel strongly about the value this test will bring to our clients.
  • The turnaround time for UTIDX is 24-48 hours compared to traditional microbiology that has a 3-5 day turnaround time.
  • "There has been a substantial gap in patient care for quite some time and we are excited to provide this solution" added Embree.
  • We understand the dependency on our accurate and timely results and our commitment to excellence in this regard is unwavering.

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

Retrieved on: 
Wednesday, July 28, 2021

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.

Microsoft’s Sensitivity Labels Get Meaning with Seclore’s Automated Protection and Tracking

Retrieved on: 
Tuesday, June 29, 2021

Documents and emails tagged as sensitive through Microsofts sensitivity labels are automatically protected with persistent, granular usage policies based on the sensitivity level selected.

Key Points: 
  • Documents and emails tagged as sensitive through Microsofts sensitivity labels are automatically protected with persistent, granular usage policies based on the sensitivity level selected.
  • With Seclore for Microsoft Sensitivity Labels, we make data classification meaningful by automatically applying the appropriate defense to the visual label.
  • Seclore for Microsoft Sensitivity Labels features includes:
    Automatic protection for classified documents and emails: Eliminates the dependency on employees to protect classified data and ensures secure collaboration and tracking of sensitive documents wherever they travel.
  • Read the blog: Seclore for Microsoft Sensitivity Labels: Give Meaning to Data Classification
    Microsoft is the leader in office productivity, stated Abhijit Tannu.

myLAB Box Launches New At-Home Food Sensitivity Test With Offered Nutritional Guidance

Retrieved on: 
Tuesday, June 29, 2021

LOS ANGELES, June 29, 2021 /PRNewswire/ -- myLAB Box , the nation's first at-home testing-to-treatment service, today announced the launch of its new Food Sensitivity test.

Key Points: 
  • LOS ANGELES, June 29, 2021 /PRNewswire/ -- myLAB Box , the nation's first at-home testing-to-treatment service, today announced the launch of its new Food Sensitivity test.
  • This new at-home Food Sensitivity test from myLAB Box offers helpful information about how a customer's body will react to 96 common foods.
  • This is two more levels of sensitivity than any other Food Sensitivity test on the market.
  • The myLAB Box Food Sensitivity test in particular will help to determine a customer's sensitivity to 96 common foods.