Included below are news items from the last six months.
The U.S. Preventive Services Task Force recently issued a final recommendation on screening for vitamin D deficiency in adults that found that there is not enough evidence to determine whether screening would be beneficial. The Task Force undertook the review of the latest evidence as the number of people taking vitamin D supplements as well as the number of patients being screened for deficiency has increased in the last few years.
A recent report from the CDC reveals that more than 10% of women in the U.S. who are recommended to receive cervical cancer screening don't get tested. Cervical cancer can go unnoticed, especially in the early stages, but can be cured or even prevented with regular screening.
The FDA seeks to oversee previously unregulated laboratory-developed tests, those that are made and used within a single laboratory. While the intent of the FDA is to provide greater safety for the public, some medical and lab professionals say the additional oversight is not needed and will hinder the availability of new tests.
New draft guidelines from the U.S. Preventive Services Task Force advise screening adults age 45 and older and those with risk factors for pre-diabetes and type 2 diabetes. The updated recommendations now more closely align with existing guidelines from the American Diabetes Association.
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.
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.
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.
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.
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.
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.
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.
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.