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Included below are news items from the last six months.

New HIV Testing Strategy Recommended for Earlier, Accurate Diagnosis

July 23, 2014

Public health officials from the CDC and the Association of Public Health Laboratories have jointly endorsed the use of a new HIV testing strategy that aims to make HIV diagnoses earlier in the course of the disease and decrease the rate of transmissions from acute infections. Early, acute HIV infections contribute disproportionately to the spread of the virus and are the source of a substantial number of new infections.

New Report Finds that Diabetes is on the Rise

July 8, 2014

A new report by the CDC has found that more than 29 million people in the U.S. have diabetes, up from the previous estimate of 26 million in 2010. Significantly, one in four people, according to the report, may not know that they have the disease.

CDC Reports Highest Number of U.S. Measles Cases Since 1994

July 3, 2014

Measles is on the rise this year, raising concern among U.S. health authorities. According to the Centers for Disease Control and Prevention (CDC), 288 cases of measles were reported between January 1 and May 23, 2014 in this country. This is the largest number of measles cases in the U.S. reported in the first five months of a year since 1994. The CDC says that nearly all of the cases reported have been linked to international travel by U.S. residents or visitors who had not been vaccinated against the disease. Vaccination is the best way to prevent measles.

New CDC Resource Helps Women Understand BRCA Gene Mutation Risk for Breast and Ovarian Cancer

June 19, 2014

The CDC recently launched a risk assessment tool called Know:BRCA as part of an education initiative to raise awareness and provide important information on BRCA genes. Mutations in BRCA genes can increase a woman's risk of developing breast and ovarian cancer and are more common in certain families and ethnic groups. The new tool helps identify women who may be at higher risk and, after genetic counseling, who might benefit from BRCA mutation testing.

CDC Confirms MERS Cases in U.S., Issues Travel Alert

May 29, 2014

Two cases of Middle Eastern Respiratory Syndrome (MERS), caused by a potentially fatal virus (MERS-CoV), have been reported in the United States by the Centers for Disease Control and Prevention. The people who were diagnosed are healthcare workers who had traveled from Saudi Arabia. Though risk to the U.S. public remains low, there is concern because MERS-CoV is highly virulent.

Chlamydia and Gonorrhea NAAT Screening Method Endorsed by CDC

May 22, 2014

In its latest recommendations to clinical laboratories, the CDC now promotes nucleic acid amplification testing (NAAT) as the preferred method to screen for two common STDs, chlamydia or gonorrhea, in men and women. The method is very sensitive and the samples required for testing are relatively easy to obtain.

Stool DNA Test Gets Nod from FDA Advisory Committee

May 9, 2014

A new option for colon cancer screening may soon be available. An advisory committee voted unanimously to recommend to the FDA that a stool DNA test be approved for marketing. Unlike other options, such as colonoscopy, the stool test is non-invasive and the sample can be collected at home with no need for bowel preparation or medication. The FDA is expected to make its decision on whether to allow the test to be marketed in the next few months.

Colon Cancer Rates Decline, Highlighting Role of Screening

April 28, 2014

Colon cancer rates have dropped by as much as 30% for adults aged 50 and older in the U.S., according to the latest statistics published by the American Cancer Society. While more needs to be done to ensure widespread access to screening, the new data suggest that improved use of colonoscopy, in particular among people 50 to 75 years of age, has contributed to lowering colorectal cancer rates.

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

April 28, 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 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.

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.

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