News Trends Analysis

Feb. 1, 2012

CDC funds HIV prevention on state and local level. The U.S. Centers for Disease Control and Prevention will contribute some $339 million in 2012 to state and local health departments throughout the U.S. to help pay for HIV prevention activities. Recipients of the funds will include eight cities, all 50 states, the District of Columbia, the U.S. Virgin Islands, Puerto Rico, and six Pacific Island locations. The money will be disbursed according to a needs-based formula, with areas that have the most people living with HIV receiving the highest proportions of the funding. To receive the support, the jurisdictions must agree to new guidelines for prioritizing educational and other activities that the CDC believes are most effective in reducing the number of new HIV infections. According to a CDC statement, “The awards are a critical component of CDC's new high-impact approach to HIV prevention, and better align resources to reflect the geographic burden of the HIV epidemic today.”

Gene Therapy

Groundbreaking treatment of hemophilia B. Researchers and clinicians are hailing the successful treatment of six patients suffering from hemophilia B via gene replacement as a landmark in the development of gene therapy. The British patients were injected with an intact version of the human gene for the clotting agent known as Factor IX. The replacement gene was loaded onto a virus that introduced it into the human cells, thereby replacing the defective gene. The patients were infused with the delivery virus, and the gene the virus carries began to produce effective copies of Factor IX. In four of the six patients the therapy was effective enough that they no longer needed the usual treatment for hemophilia B, which is a regimen of injections of Factor IX concentrate from donated blood. The other two still needed Factor IX concentrate, but less often. Nearly two years after the infusion, the patients were still producing their own Factor IX.

The implications of the successful therapy, as small as the sampling was, are significant, in that treatment of a patient with the concentrate can cost as much as $300,000 a year. The single injection of the delivery virus costs about one-tenth that much. Researchers will now focus on determining what one referred to as “the sweet spot”—the exact dose of the virus that does not set off an attack on the intruder by the immune system. That problem—the fact that the immune response tends to render the treatment ineffective—remains the greatest obstacle to the widespread use of gene therapy to treat genetic disease.

Infectious Diseases

OraSure receives CLIA waiver for HCV rapid test. OraSure Technologies, Inc. announced that the FDA has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens. The test, the first FDA-approved rapid test for the detection of antibodies to the hepatitis C virus, utilizes the OraQuick® technology platform and provides results in 20 minutes. With this waiver, the assay now can be used by more than 180,000 sites in the United States to test persons who are at risk for hepatitis C or have symptoms of hepatitis. These sites now include facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations, and physician offices.

“Today, more than four million Americans are infected with hepatitis C, and the vast majority does not know it,” says Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. “Hepatitis C is a leading cause of chronic liver disease, cirrhosis, and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic.”

New Studies

Can age-related effects in MS be reversed? According to researchers at Joslin Diabetes Center, Harvard University, and the University of Cambridge, the answer may be yes. In a study published in the journal Cell Stem Cell, they assert that a process associated with the progression of multiple sclerosis may be corrected. Part of the reason MS tends to worsen as patients get older is that the body's ability to replace the myelin sheaths that surround nerve fibers and cause them to function normally is impaired in aging MS patients. According to the researchers, studies indicate that defects in myelin sheath regeneration can be at least partly corrected by surgically introducing cells found in the blood of younger mice into the spinal cords of older mice. The infusion of the “younger” macrophages enables stem cells to restore remyelination in the older animals' spinal cords. Apparently, the younger cells have this rejuvenating effect because they can more efficiently clear away myelin debris. Further study is needed to determine the therapeutic value of this research for humans with MS, but the development is encouraging: stem cell therapy may someday help older MS patients to avoid the decrease in remyelination that eventually leads to permanent impairment of nerve fibers. Regeneration of myelin sheaths may eventually become possible for MS patients at every stage of the autoimmune disease.


The Association for Molecular Pathology Annual Meeting, held in Grapevine, Texas, featured a plethora of valuable and thought-provoking sessions for clinicians and laboratorians. Plenary sessions covered such timely topics as circulating tumor cells and nucleic acids; SNP arrays in hematopathology and solid tumors; next generation sequencing; multianalyte testing in infectious diseases; and pharmacogenomics: molecular genetics in drug development. Concurrent workshops included such topics as viewpoints on payment for molecular testing; genetics sendout testing; clinical application of whole genome sequencing; mupirocin resistance in MRSA colonized residents in long-term care facilities; molecular CPT coding structure; anti-viral susceptibility testing; exome and whole genome sequencing; the human microbiome; and a regulatory update on LDTs and companion diagnostics—among many, many other compelling sessions. Impressive poster sessions and useful exhibits by providers of products and services to the laboratory rounded out a conference that enabled attendees to immerse themselves in the work of their colleagues and apply it to their own institution's mission and objectives.

The Annual Meeting Program stated the conference's objective succinctly: “to increase basic and applied pathology knowledge, focusing on the molecular diagnosis and prognosis of disease as well as targeted molecular therapies. The meeting will provide a forum for the exchange of new research by scientists and investigators and is designed to support participants' lifelong learning towards a goal of promoting patient safety and improving patient care.” AMP met this objective with conspicuous success. Read more about this cutting-edge association at