Diagnostic Agents

Accuracy of Artificial Intelligence Assessed in CA Diagnosis

December 12, 2017

The researchers found that the AUC of the DLS for referable diabetic retinopathy was 0.936, and sensitivity and specificity were 90.5 and 91.6%, respectively

Blood Glucose Meter Test Strips

December 07, 2017

Blood Glucose Meter Test Strips chart

Blood Glucose Meter Compatibility with Test Strips

December 07, 2017

Blood Glucose Meter Compatibility with Test Strips chart

First Flushable Pregnancy Test Cleared for OTC Use

By December 05, 2017

The Lia Pregnancy Test is made with the same plant based fibers as most toilet paper and weighs less than 6 squares of the leading 3-ply toilet paper.

New Study Sheds Light on Safety of Gadolinium-Based Contrast Agents

By November 29, 2017

After adjusting for gender, age, education level, baseline neurocognitive performance, and others, the authors reported gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychological performance or diminished motor performance

FDA: Vitamin May Interfere With Lab Tests, Already One Fatality Reported

By November 28, 2017

The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

FDA Approves InSure One to Aid in Detecting Lower GI Bleeding

By November 13, 2017

The InSure ONE requires a sample of water from the toilet bowl, after the stool surface has been brushed to release any blood.

Soluble Interleukin 2 Receptor Assessed as Biomarker of Sarcoidosis in Uveitis

November 13, 2017

To compare the value of soluble interleukin 2 receptor (sIL-2R) with ACE as diagnostic biomarkers of sarcoidosis in patients with uveitis.

New Immunoassays Show Improvement in Measuring Aβ42 in CSF

November 09, 2017

The researchers found that the mass spectrometry-derived Aβ42 values showed higher correlations with the modified Aβ42-INNOTEST, Aβ42-FL, Aβ42-EI, and Aβ42-MSD assays versus the classic Aβ42-INNOTEST assay.

New CBC Test Allows for Testing in More Settings, Reduced Processing Time

By November 06, 2017

This broadened test access will allow for faster availability of results.

Two Simple Tests May Help PCPs Identify Fibromyalgia

November 01, 2017

"These results suggest that two tests, taking less than one minute, can indicate a probable diagnosis of FM," write the authors.

Three Antimicrobial Susceptibility Tests Approved for Baxdela

By October 30, 2017

The newly cleared ASTs include: Hardy Diagnostics' Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk), Liofilchem Delafloxacin MIC Test Strip (MTS), and Thermo Scientific Sensititre MIC System.

Can DNA 'Liquid Biopsy' Diagnose Hepatocellular Carcinoma?

October 17, 2017

"Together, these findings demonstrate in a large clinical cohort the utility of ctDNA methylation markers in the diagnosis, surveillance, and prognosis of HCC," write the authors.

New Therapeutic Drug Monitoring Test for Ustekinumab Announced

By October 16, 2017

By measuring drug and antibody concentrations physicians can adapt treatment strategies and guide patients toward more personalized medicine.

Noninvasive Test Monitors Healing Status in Crohn's Disease Patients

By October 16, 2017

The PROMETHEUS Monitr Crohn's Disease test can be used as an adjunct to endoscopy or by itself between endoscopies.

CMR Imaging Role Assessed in Myocarditis Prognosis

October 13, 2017

The researchers found that 98 patients experienced a major adverse cardiovascular event (MACE) at a median follow-up of 4.7 years.

FDA Clears First Seven Tesla MRI Device

By October 12, 2017

The FDA reviewed a 510(k) premarket submission for the device by Siemens and based its clearance on comparison to a predicate device and sample clinical images.

Test to Detect Zika in Blood Donations Gets FDA Approval

October 10, 2017

Not designed to diagnose the infection, however

Survey Reveals Impact Medical Errors can Have on U.S. Patients

October 06, 2017

Ambulatory settings are a frequent site of medical errors, and the most commonly reported errors were related to diagnosis and patient-provider communications.

Test Helps Clinicians Select Appropriate Tx for Suspected Wound Infections

By October 05, 2017

Using a simple swab from the infection site, DxWound uses a special transport buffer that preserves the wound microbiome during transit.

Potential Prognostic Biomarker ID'd for Triple-Negative Breast CA

September 26, 2017

African-American patients harbored significantly more tumor-infiltrating lymphocytes than European Americans among early-stage (I to II), but not late-stage (III to IV), patients.

First Fecal Tagging Agent Approved for Virtual Colonoscopy

By September 25, 2017

Tagitol V, a low-volume fecal tagging agent, opacifies remaining stool in the colon for CT imaging. It will be available as a 40% w/v oral suspension in boxes containing three 20mL bottles.

USPSTF: Cervical Cancer Screening Recommendations Issued

September 13, 2017

For women aged 21 to 29 years, the USPSTF recommends screening for cervical cancer with cervical cytology alone every 3 years. For women aged 30 to 65 years, the USPSTF recommends screening every 3 years with cervical cytology alone or every 5 years with hrHPV testing alone (A recommendation).

Current Diagnostic Tools Failing to ID Bacterial Infections in Infants

September 12, 2017

Sensitivities were low for common complete blood cell count thresholds: white blood cell count <5,000/µL, 10%; white blood cell count ≥15,000/µL, 27%; absolute neutrophil count ≥10,000/µL, 18%; and platelets <100 × 10³/µL, 7%.

Handheld Pen Device Rapidly Detects Cancerous Tissue

By September 08, 2017

Researchers at the University of Texas, who developed the MasSpec Pen device, tested its capability on 20 thin tissue sections (including breast tissues, thyroid tissues, papillary thyroid carcinoma, and follicular thyroid adenoma tissues) and 253 human patient tissue samples (including lung, ovary, thyroid and breast samples) some normal and some cancerous.

Dotarem Approved for Use in Children Under Two Years Old

By September 06, 2017

The approval was based on a study (n=51) which showed that at the standard dose, the pharmacokinetic and safety profiles for this gadolinium-based contrast agent were similar for patients under the age of 2 and in older children and adults.

Mammography Device with Patient-Assisted Compression Gets FDA Approval

By September 05, 2017

Using a handheld wireless remote control, the patient can adjust the compression force after breast positioning by a technologist.

Sefria Fentanyl Screening Test Gets FDA Clearance

By August 03, 2017

The test has demonstrated cross-reactivity with acetyl fentanyl, butyryl fentanyl, despropionyl fentanyl, and sufentanil.

Blood Glucose Meter Comparisons

August 01, 2017

Blood glucose meters comparison chart including injection site, sample size, range, result time, calibration method, memory size, and battery type.

Idhifa Approved for Relapsed/Refractory AML with IDH2 Mutation

By August 01, 2017

The drug carries a Boxed Warning regarding the risk of differentiation syndrome.