Included below are news items from the last six months.
The FDA has approved for the first time a genetic carrier test to be sold to directly to consumers. The screening test lets prospective parents know whether they carry a defective gene and could pass a rare disorder to their children.
U.S. Government to Drop Warning on Dietary Cholesterol, but High Blood Cholesterol Still Important Health Risk
HHS and USDA are set to release new 2015 Dietary Guidelines for Americans that drop the long-standing advice to limit foods high in dietary cholesterol. However, this does not change recommendations to keep blood cholesterol levels low and to screen regularly for high blood cholesterol.
Last year, the FDA approved for the first time a high-risk HPV test as a primary screening tool for cervical cancer but did not address how such screening would be applied. Now, a panel of experts has developed interim guidelines for health practitioners who may be interested in offering the hrHPV test to their patients without a Pap smear.
The CDC issued a health advisory on January 23 in response to an ongoing measles outbreak. Public health officials think that most of these recent cases can be attributed to a larger, ongoing outbreak that started in December 2014 among people who were exposed to measles at a California amusement park. The alert is a reminder that measles still affects people in the U.S. and that vaccination is the best protection against this highly contagious infection that can have serious consequences.
A rapid test for syphilis has been granted a waiver by the FDA for use in a wider variety of healthcare settings, such as emergency rooms, clinics, and other outpatient settings. The test is performed on a fingerstick sample and results are available in less than 12 minutes. This wider availability of the test may help lead to a higher rate of detection, which could allow for timely treatment and a decline in the spread of the infection.
The FDA recently approved a test for lipoprotein-associated phospholipase A2 (Lp-PLA2) activity that helps predict risk of future coronary heart disease events, such as heart attacks. It is intended to be used along with a clinical evaluation and cardiac risk assessment to help determine risk in people with no history of heart disease and is particularly helpful in predicting risk in women, especially African American women.
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.