Diagnostic Agents

Quick New Ebola Test Approved by FDA

November 12, 2018

The emergency use authorization is for the DPP Ebola Antigen System. It analyzes blood samples from people who have signs and symptoms of Ebola in addition to other risk factors.

Age to Stop Cervical Cancer Screening Depends on Test Used

November 05, 2018

The model predicted lifetime risk for cervical cancer to be 1 in 45 for women without HPV vaccination who have never been screened. Incremental decreases in cancer risk were seen later in life with increasing age at which women stopped cytology screening from 55 to 75 years.

FDA: Class I Recall of Test Strips Due to Inaccurate INR Results

By November 02, 2018

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled.

New Blood Test Identifies Metabolic Subtypes Linked to Autism Spectrum Disorder

By November 02, 2018

The NPDX AA test works by detecting amine imbalances in a child's fasting blood sample with very precise thresholds that were identified and validated based on samples from the Children's Autism Metabolome Project (CAMP) study (N=1100) in patients aged 18 to 48 months

FDA-Approved Test Provides Pharmacogenetic Reports Directly to Consumers

By November 01, 2018

The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.

FDA Approves Diagnostic Test to Help Determine Menopausal Status

By October 25, 2018

The FDA's marketing approval was supported by data from 690 women (aged 42 to 62 years) who were enrolled in the Study of Women's Health Across the Nation.

Handheld Device Inspired by Star Trek May Allow Rapid Diagnosis

October 01, 2018

Device uses enzyme-based assays to measure metabolites.

MRI Indicates Sacroiliitis in Some Healthy Individuals

September 24, 2018

Healthy volunteers, patients with chronic back pain, and runners did not have deep bone marrow edema lesions, but 89.4% of axial SpA patients and 14.3% of women with postpartum back pain did have lesions.

Sensitivity for CRC Detection Up With Decreasing FIT Threshold

September 21, 2018

At lower positivity thresholds, there was an increase in cancer detection, from 66% at 30µg/g to 74.3% at 20µg/g and 79.3% at 10µg/g; there was also an increase in the number of positive test results per cancer case detected, from 43 to 52 and 85 at 30, 20, and 10µg/g, respectively.

Chest Radiograph Effective for Excluding Pediatric Pneumonia

September 12, 2018

The researchers found that 72.8% of children had negative CXRs, with 8.9% of these children clinically diagnosed with pneumonia and 9.3% given antibiotics for other bacterial syndromes.

Biomarker Panel May Improve Lung Cancer Risk Assessment

August 06, 2018

The integrated risk prediction model combining smoking exposure with the biomarker score yielded an area under the curve of 0.83 versus 0.73 for a model based on smoking exposure alone.

Plasma Copeptin More Accurate for Diabetes Insipidus Diagnosis

August 06, 2018

"This prospective evaluation of patients with hypotonic polyuria validated hypertonic saline-stimulated copeptin measurement as a diagnostic method that appeared to be superior to the indirect water-deprivation test in distinguishing central diabetes insipidus from primary polydipsia," the authors write.

Tool Improves Identification of Undiagnosed Hypertension

July 30, 2018

The tool was applied using medical billing data alone and in combination with clinical data from 8.92 million patients from 25 organizations participating in the American Medical Group Association national learning collaborative to calculate and compare predicted and observed adult hypertension prevalence.

Researchers Develop First Blood Test for Melanoma

July 19, 2018

The researchers identified a combination of 10 autoantibody biomarkers that, as a panel, displayed a sensitivity, specificity, and an area under the curve of 79%, 84%, and 0.828, respectively, for primary melanoma detection.

Fresenius Kabi Adds Additional Strengths to Adenosine Product Line

By July 11, 2018

Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

Pelvic Exam in ER Doesn't Help Predict STI for Young Females

July 10, 2018

A practitioner obtained a standardized history from the patient to assess for cervicitis or pelvic inflammatory disease; pelvic examination was performed by the same practitioner.

Patient Interest Fairly High for Melanoma Genetic Risk Testing

July 10, 2018

The researchers found that 232 of the 499 participants randomized to MC1R testing logged on to the website, and of these, 88% (204 participants) requested testing and 82% (167 participants) returned the test kit.

Handheld, Wireless Ultrasound Device SONON 300L Now Available

By July 09, 2018

The device is indicated for ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal, vascular, small parts (breast, thyroid), and lung imaging.

Post-Endoscopic Infection More Common Than Previously Thought

June 22, 2018

The rates of infections were compared with those after screening mammography, prostate cancer screening, bronchoscopy, and cystoscopy procedures.

AAFP Still Recommends CRC Screening From Age 50 to 75

June 21, 2018

The AAFP agrees with the USPSTF recommendation for screening patients at ages 50 to 75 years, and graded its recommendation B.

Cleared Blood Glucose Monitor Systems Not Always Accurate

June 19, 2018

"Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance," the authors write.

USPSTF: No to ECG Screening to Prevent CVD in Low-Risk Adults

June 13, 2018

The researchers found that it is very unlikely that the information from resting or exercise ECG would result in a change in a patient's risk category that would lead to a change in treatment or improve health outcomes for asymptomatic adults at low risk for CVD events.

New Coagulation Monitoring Device Allows for Wireless Reporting of INR Results

By June 11, 2018

The system is intended for properly selected trained users ≥22 years of age who have been stabilized on anticoagulation with vitamin K antagonists for ≥6 weeks.

ASCO: New Assays May Detect Early Lung Cancer in Blood

June 06, 2018

The researchers found that more than 50% of the 3,055 nonsynonymous mutations detected across 122 evaluable patients with lung cancer were detected in WBC consistent with clonal hematopoiesis.

Should Genealogy Data Be Used for Criminal Justice Purposes?

By May 30, 2018

Informed consent, privacy, and justice concerns are 3 issues that should be addressed before the use of online genealogy data in criminal cases becomes widely adopted.

Extended INR Test Intervals Safe for Warfarin-Treated Patients

May 23, 2018

Similar number of out-of-range next INR values for patients with, without extended testing interval

FDA: New Med Guide for Patients Receiving Gadolinium-Based Contrast Agents

By May 17, 2018

These Medication Guides should be provided the first time an outpatient receives a GBCA injection at an MRI center; hospital patients are not required to receive a Medication Guide.

First Test to ID <i>Candida auris</i> Gets FDA Approval

By April 23, 2018

The Bruker Maldi system is already cleared for use in identifying 333 species or species groups, including 424 bacteria and yeast species.

FDA Approves Unique Device for Diabetic Retinopathy Screening

By April 11, 2018

This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.

Few Indoor Tanners Have Been Screened for Skin Cancer

April 05, 2018

"Few indoor tanners (ITs) have been screened for skin cancer, although skin cancer (SC) rates are higher than among non-tanners," the authors write. "It is not surprising that SC screening is associated with SC risk factors (e.g., family history of SC and age) among ITs."