Miscellaneous Diagnostic Tests

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.

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.

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.

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: 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.

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.

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.

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.

New HBV Quantitative Test Helps Evaluate Drug Response

By January 18, 2017

Quest Diagnostics announced the availability of a new test to aid physicians in evaluating a patient's response to drug treatments for hepatitis B virus (HBV) infection. This first-of-its-kind test can help physicians prescribe more effective treatments for patients with HBV.

Length of Hospital Stay Examined After Procalcitonin Test

January 17, 2017

For patients admitted to the intensive care unit (ICU), procalcitonin (PCT) testing on the first day of admission is associated with significantly lower length stay in the hospital and ICU, according to a study published in the January issue of CHEST.

Could a Simple Test Help Prevent Fatigue-Related Mistakes?

By November 30, 2016

Of the thousands of metabolites identified, three candidates were recognized as potential indicators of fatigue.

Can a Saliva Test Help Predict Future Alzheimer's Disease?

By November 21, 2016

Aurin Biotech announced the development of a saliva test that can diagnose Alzheimer's disease and predict future onset.

Simple Blood Test Promising in Detecting Concussion

November 15, 2016

A simple blood test may one day diagnose concussions with more than 90% certainty, according to a study published online October 28 in Metabolomics.

Five-Item Questionnaire, PEF Help ID Undiagnosed COPD

October 31, 2016

A five-item questionnaire plus peak expiratory flow (PEF) can identify undiagnosed chronic obstructive pulmonary disease (COPD), according to a study published online in the American Journal of Respiratory and Critical Care Medicine.

New Molecular Test Cleared to Detect Vaginitis Causes

By October 31, 2016

BD announced that the Food and Drug Administration (FDA) has granted marketing clearance for BD MAX Vaginal Panel to detect the most common causes for vaginitis.

Blood-Based Companion Diagnostic Test for Osimertinib Approved

By September 29, 2016

AstraZeneca announced that the Food and Drug Administration (FDA) has approved cobas EGFR Mutation Test v2, a companion diagnostic for Tagrisso (osimertinib).

More Genetic Disorders May Be ID'd With Expanded Carrier Screening

August 17, 2016

Compared with current recommendations from professional societies, expanded carrier screening may increase the detection of carrier status for potentially serious genetic conditions, according to a study published in the Journal of the American Medical Association.

USPSTF Issues Statement on Lipid Screening in Children, Teens

August 10, 2016

The U.S. Preventive Services Task Force (USPSTF) has concluded that the evidence is currently insufficient to weigh the balance of benefits and harms of screening for lipid disorders in children and adolescents (aged 20 years or younger). These findings form the basis of a final recommendation statement published in the August 9 issue of the Journal of the American Medical Association.

'Targeted' Cell-Free Fetal DNA Screening For Trisomy May Limit Costs

July 06, 2016

Limiting first trimester screening (FTS) by cell-free fetal (cff) DNA to only patients in certain risk categories may be a feasible cost-containing strategy, according to a study published online in the Journal of Evaluation in Clinical Practice.

FDA Approves Test for Rapid Detection of Certain Superbugs

By June 30, 2016

The Food and Drug Administration (FDA) has cleared Xpert Carba-R Assay, the first test to detect specific genetic markers associated with bacteria that are resistant to carbapenem antibiotics.

Breath Analysis Test May Help Diagnose IBS

By May 11, 2016

A new study has shown the potential use of a breath analysis test to help diagnose and monitor irritable bowel syndrome (IBS).

First DNA-Based Blood Test for Colorectal Cancer Now Available

By May 09, 2016

LabCorp announced the availability of Epi proColon, a blood-based test for colorectal cancer screening.