Diagnostic Agents

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.

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.

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.

Varibar Nectar Approved for Oropharyngeal Function Testing

By July 28, 2017

Varibar Nectar — with target viscosity 300 CPS — comes in an apple flavor for improved patient compliance and is designed to provide the least coating properties necessary to visualize the swallowing process.

Updated Prescribing Information for ChiRhoStim

By July 25, 2017

ChiRhoStim is available as 16mcg and 40mcg strength lyophilized powder in single-dose vials for reconstitution.

Blood Glucose Meter Compatibility with Lancets and Test Strips

July 24, 2017

Blood Glucose Meter Compatibility with Lancets and Test Strips chart

FDA Clears First MRI Device for Neonatal Imaging in NICU

By July 21, 2017

The Embrace Neonatal MRI System is specifically designed for imaging of the neonatal head (head circumference up to 38cm and weight of 1 - 4.5kg).

New Urine Test Quickly Detects Commonly Abused Rx Drugs

By July 19, 2017

The rapid detection tests consists of a self-contained collection cup and test device with auto-activated results seen in 5 minutes with no tipping of the cup.

FDA Approves Test to Detect Several Blood Cancers

By June 30, 2017

The data informs labs and clinicians on the type of leukemia or lymphoma present by marking proteins found on the surface of cells with fluorescent dyes. These markers are further analyzed on a flow cytometer.

Reasons Why Patients Might Change Doctors Detailed in New Study

June 28, 2017

Although 49% of patients stay with their doctor for 5 years or more, the authors note that 1 quarter of patients are likely to switch physician if they find a doctor with a more positive attitude.

FDA Approves Combo Tx for Metastatic NSCLC with BRAF V600E Mutation

By June 23, 2017

The approval for Tafinlar and Mekinist combination therapy was based on a Phase 2 international, multicenter, 3-cohort, non-randomized, non-comparative, open-label trial (Study BRF113928) in patients with locally confirmed stage IV NSCLC with BRAF V600E mutation.

First Fluorescing Agent Approved for Use with Gliomas

By June 08, 2017

The approval was supported by three prospective studies that showed aminolevulinic acid-induced fluorescence was highly predictive for visualizing malignant tissue as verified by histopathology of biopsied fluorescent tissue.

New Diagnostic Test May Help Predict Heart Disease Risk

By June 06, 2017

Combining cholesterol uptake capacity with known cardiovascular disease risk factors also significantly improved the power of those factors to predict patients who would re-develop heart disease.

Test Strip May Help Heart Failure Patients Self-Monitor

By May 24, 2017

A paper-based test was created which requires a small sample of blood (10mcL). If the ST2 antigen is present in the sample, a blue dot appears on the strip; if the BNP antigen is present in the sample, then a green dot appears.

FDA Update on Use of Gadolinium-Based Contrast Agents for MRI

By May 22, 2017

Some of these studies evaluated GBCA use for durations >1 year and showed that gadolinium is retained in organs such as the brain, bones, and skin.