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Included below are news items from the last six months.

Blood Test for T-tau Shows Promise for Diagnosing, Managing Concussions

April 14, 2014

Researchers believe they have found a protein detectable in blood that could be used to help rapidly diagnose a concussion, leading to better management of those affected. While the biomarker, total tau or T-tau, needs to be evaluated in larger studies, it raises hope that health practitioners may in the future be able to use blood tests to manage head injuries and make return-to-play decisions for athletes following a concussion.

FDA Advisory Committee Recommends an HPV Test as a Primary Screen for Cervical Cancer

April 14, 2014

An FDA advisory panel has voted unanimously to recommend to the FDA that a human papilloma virus (HPV) test be approved for marketing in the U.S. as a primary screening tool for cervical cancer. Currently, only the Pap smear is used for primary testing and HPV tests are recommended only in conjunction with or as a follow up to Pap smears. If approved by the FDA, the HPV test might become an initial screening option for women.

Blood Test Shows Very Preliminary Results in Predicting Alzheimer Disease

March 26, 2014

Researchers have developed an experimental blood test that may be able to be used to predict whether someone will develop Alzheimer disease. Although currently there is no prevention or cure for the disease, the test could aid in the development of treatments and help identify people at risk so they could then plan for managing the disorder. However, some scientists caution that the results of the study must be replicated in other laboratories and that the researchers may be overly optimistic about the clinical benefit of the test at this time.

FDA Proposes Two Sets of Standards for Glucose Meters

March 13, 2014

The U.S. Food and Drug Administration has released two separate draft guidance documents detailing the agency's recommendations for manufacturers to improve both over-the-counter and point-of-care blood glucose meters. This marks the first time that the FDA has issued separate documents for the two types of meters, stemming from the need to address the different ways that patients and professionals use the meters.

AAP Updates Screening and Assessment Recommendations for Well-Child Visits

March 13, 2014

The American Academy of Pediatrics has updated its schedule of the screenings and health assessments that are recommended at each well-child visit from the time a baby is born through age 21. Well-child visits generally involve screening tests, including laboratory tests, as well as other assessments that are done routinely to help evaluate a child's health and recommend treatment, if needed.

HHS Issues Final Rule that Allows Patients Direct Access to Lab Test Results

March 3, 2014

The U.S. Department of Health and Human Services (HHS) has issued a final rule that now allows a patient, or a person designated by the patient, direct access to laboratory test reports without the need to have the tests sent to a physician first.

Cervical Cancer Screening that Includes HPV Test Better than Pap Smear Alone, Study Concludes

February 19, 2014

Based on analysis of data from four large, randomized clinical trials, an international HPV screening working group has concluded that screening with a test for human papillomavirus (HPV) in addition to a Pap smear is more effective than Pap smears alone in reducing the rate of invasive cervical cancer.

High Influenza Activity in the U.S.

February 18, 2014

Influenza (flu) activity remains high in the U.S. this season, according to the Centers for Disease Control and Prevention (CDC). The flu season usually peaks between January and March and the 2013-2014 season seems to be following this pattern, but flu infections appear to be more severe and affecting more people in more parts of the country than in previous years.

FDA Directs Genetic Testing Company to Stop Selling Health-related Tests

January 29, 2014

The FDA recently instructed a genetic testing company to discontinue marketing saliva collection kits and personal genomic services for the purpose of health information until the company has provided evidence that their tests perform as intended. Genetic tests can cause serious consequences if not properly validated and results interpreted correctly. The company has complied with the FDA's instruction and has notified customers with a message on its website that it has suspended its health-related genetic test reporting during its regulatory review process.

Cases of Chikungunya Fever Confirmed in the Caribbean

January 16, 2014

Cases of the mosquito-borne viral infection chikungunya have been reported in several islands in the Caribbean, leading the U.S. Centers for Disease Control and Prevention (CDC) to issue a travel health notice. According to the CDC, this is the first time that local transmission of this particular virus has been reported in the Americas.

USPSTF Recommends Screening All Pregnant Women for Gestational Diabetes

January 14, 2014

The U.S. Preventive Services Task Force (USPSTF) has released new guidelines recommending that all pregnant women be screened for gestational diabetes—diabetes that develops during pregnancy—after 24 weeks of pregnancy. Since this condition may produce no obvious signs or symptoms yet result in serious complications for both mother and baby, glucose testing is recommended to screen women at the end of their second trimester. The updated guidelines from the USPSTF come into closer alignment with the advice of several other medical organizations, including the American College of Obstetricians and Gynecologists and the American Diabetes Association.

OB/GYNs Say High Urine Protein No Longer Necessary for Preeclampsia Diagnosis

December 20, 2013

The American College of Obstetricians and Gynecologists (ACOG) recently issued a report by its Task Force on Hypertension in Pregnancy that recommends changes to the way preeclampsia – a severe form of high blood pressure – is diagnosed. Specifically, the Task Force is recommending that the presence of high levels of protein in a pregnant woman's urine no longer be a requirement for diagnosis due to concerns that relying on that sign could hamper timely diagnosis and treatment of preeclampsia in some women.

Experts Announce Major Updates to Guidelines for Heart Disease Risk Assessment and Prevention

December 19, 2013

The American College of Cardiology and the American Heart Association have released extensive new guidelines for cardiovascular disease (CVD) risk assessment intended to better define what important factors are involved in determining CVD risk and to provide ways to reduce risk through treatment and lifestyle modifications. The guidelines are long-awaited after the organizations took five years to perform a comprehensive review of new research and the latest cardiovascular medical evidence. It is not yet known how the recommendations will impact clinical practice, and any changes that may take place will be implemented over time.

Cancer Groups Release New Guideline on HER2 Testing for Breast Cancer Patients

December 3, 2013

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) have joined forces to issue an updated guideline on testing for human epidermal growth factor receptor 2 (HER2) in patients with invasive breast cancer. Such testing identifies patients who could benefit from treatment that targets HER2.

Choosing Wisely Campaign Identifies Overused Endocrinology Tests

November 22, 2013

The Endocrine Society and the American Association of Clinical Endocrinologists (AACE) have joined the Choosing Wisely® campaign, making recommendations for the appropriate use of certain laboratory tests ordered as part of patient care related to hormone disorders and conditions.

Study Says Fasting Necessary for Creatinine Testing

November 15, 2013

Although current standards for creatinine blood tests do not require fasting, a new study recommends a 12-hour fast or refraining from eating cooked meat prior to testing. Consuming cooked meat can temporarily increase the level of creatinine in the blood, possibly causing artificially high test results.

Interactive Personal Health Records Boost Participation in Preventive Services

November 8, 2013

Patients who choose to use an online interactive personal health record (IPHR) are almost twice as likely to be up to date with recommended preventive health services, including laboratory screenings, as those who don't, according to a recent study. Researchers evaluated use of an online system that created personalized recommendations for patients based on their input on health questionnaires, their medical records, and guidelines from the U.S. Preventive Services Task Force. Findings suggest that IPHRs may prove to be a valuable tool for improving healthcare for patients who wish to take a more active role in their care.

NGAL Shows Promise as Early Marker of Acute Kidney Injury

October 31, 2013

A recent study suggests that a blood test for neutrophil gelatinase-associated lipocalin (NGAL) is a valuable tool for predicting which patients admitted to the hospital will develop a sudden loss of kidney function, known as acute kidney injury (AKI). If not detected and treated quickly, AKI can cause permanent kidney damage and can be life-threatening.

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