Diagnostic Agents

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.

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.

FDA: Inaccurate Lead Tests ID'd, Retests Necessary for Some

By May 17, 2017

Certain lead tests manufactured by Magellan Diagnostics may have provided inaccurate results to patients, according to the Food and Drug Administration.

Prostate-Specific Antigen Testing Patterns Examined

April 25, 2017

In 2012 the USPSTF recommended against PSA testing for men of all ages.

FDA Approves Test for Suspected Polycythemia Vera Evaluation

By April 07, 2017

The ipsogen JAK2 RGQ PCR Kit test detected polycythemia vera with 94.6% sensitivity and 98.1% specificity, in the study the approval was based on.

First Consumer Genetic Health Risk Tests Get FDA Approval

By April 06, 2017

While the GHR tests may provide genetic risk information, they cannot determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk.

CVD Risk Better Predicted with These 5 Tests

By March 31, 2017

Overall, the combined 5 tests allowed a broader risk prediction to include the likelihood of heart failure and atrial fibrillation, and also showed to be a better predictor of heart attack and stroke vs. currently recommended strategies.

Review: Clinical Decision Making on Ketamine Tx for Mood Disorders

March 09, 2017

Most studies supporting ketamine's benefit assessed efficacy during the first week following a single infusion; emerging studies indicate that repeated dosing may extend the efficacy for at least several weeks.

Genetic Testing Abused by Patient with Factitious Disorder

By March 08, 2017

The patient presented with complaints of increased muscle tone in her back muscles and the right side of her body starting in adolescence.

CDC: Cancer Screening 'Considerably' Below Targets

March 07, 2017

The researchers found that screening test use remained considerably below HP2020 targets for selected cancer screening tests.

Diagnostic Digital Mammograms Show Mixed Accuracy Outcomes

March 01, 2017

Digital imaging has improved diagnostic capability of mammograms but the percentage of false-positives is up, too, according to a study published online in Radiology.

Varibar Pudding Approved for Use in Oropharyngeal Evaluation

By February 28, 2017

Bracco Diagnostics announced that the Food and Drug Administration (FDA) has approved Varibar Pudding (barium sulfate) oral paste for modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology.

Blood Measure May Help Distinguish Atypical Parkinsonian Disorders

February 09, 2017

Measuring blood neurofilament light chain (NfL) levels may help distinguish Parkinson's disease (PD) from atypical parkinsonian disorders (APD), according to a study published onlinein Neurology.

Are ER Physicians 'Choosing Wisely'?

By February 07, 2017

Many emergency physicians are performing low-value services, despite patients being deemed low-risk. The findings come from a cross-sectional sample survey of nearly 800 emergency physicians.

FDA Approves Screening System that Detects Metabolic Disorders in Newborns

By February 06, 2017

The Food and Drug Administration has approved the marketing of the Seeker System (Baebies, Inc.) for the screening of four rare lysosomal storage disorders (LSDs) in newborns.

Breath Test to Detect GI Cancers Shows Promise

February 03, 2017

Test could reduce the number of unnecessary endoscopies, researcher says

Test May Predict Ebola Survival, Mechanism of Pathogenesis

January 24, 2017

A blood test may help determine a patient's chance of surviving Ebola infection, according to a study published online January 19 in Genome Biology.