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Included below are news items from the last six months.

Ebola Outbreak Continues, CDC Coordinates Efforts to Combat Disease

October 15, 2014

Ebola continues to be a major international public health concern and now the first known transmissions of the virus have occurred in the U.S. A healthcare worker has contracted the disease from a patient she took care of in a hospital in Texas, and a second healthcare worker has tested positive. The situation in Texas is evolving and a CDC team is prepared to assist the healthcare system in Texas deal with additional healthcare personnel who become symptomatic.

Should All Women Be Screened for BRCA Mutations that Increase Breast Cancer Risk?

October 10, 2014

Currently, BRCA screening is recommended only for women with family history of breast or ovarian cancers or whose ancestry confers higher risk. In the online version of the Journal of the American Medical Association, Marie-Claire King, PhD of the University of Washington recommends that at about age 30, all women undergo routine testing for risk-causing mutations in the BRCA1 and BRCA2 genes. However, some experts have noted several potential problems with her proposal.

First Lab Test Approved Through Joint FDA-Medicare Review Process

September 25, 2014

An ongoing pilot program by the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) aims to cut down on the time it takes for newly approved tests to be covered by CMS. One clinical laboratory test, a stool DNA test for colon cancer screening, has been reviewed through this process, making history by being the first to be approved by FDA and, on the same day, receive a decision by CMS that Medicare and Medicaid will pay for the test.

Enterovirus D68 Causing Acute Respiratory Illnesses across States

September 19, 2014

A respiratory virus called enterovirus D68 (EV-D68) is causing a serious illness in children in several states, sending many of them to hospitals. The first cases were identified in mid-August and now a number of states are investigating clusters of enterovirus illnesses. The CDC is advising physicians to be vigilant for this viral illness in their patients and to consider testing for EV-D68 in certain cases.

Lab Reports Confusing for Many Patients and Need Redesign, Says Study

September 17, 2014

Although the U.S. Department of Health and Human Services recently passed a rule granting patients direct access to their laboratory results, a new study from the University of Michigan has found that some people may not be able to understand lab reports in a meaningful way. Current formats for lab reports pose a barrier to understanding, say the researchers, and should be redesigned in order to help patients take a more active role in their health care.

New Study Finds Mutations in PALB2 Gene Increase Lifetime Risk of Breast Cancer

August 28, 2014

An international team of researchers has found that mutations in the PALB2 gene are an important cause of hereditary breast cancer. The scientists suggest that evaluations of breast cancer risk should include tests for PALB2 mutations, along with the better known BRCA mutations tests. However, additional studies are likely needed before major health organizations support its inclusion.

FDA Provides Guidance on Companion Diagnostics

August 15, 2014

The FDA has released its new final guidance on companion diagnostics. These are laboratory tests that are developed in conjunction with new therapies and are often essential in determining whether the therapies will be effective in certain patients. The goal of the guidance is to provide faster access to new treatments for people with serious and sometimes life-threatening conditions.

Stool DNA Test Gets Nod from FDA Advisory Committee

August 12, 2014

UPDATE (8/12/14): The FDA has approved the stool DNA test reported in this article.
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.

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.

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.

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