News, Trends, Analysis

Jan. 17, 2013


CDC reports that HIV is on the rise among the young. It may be because too many of them think that the HIV epidemic is somehow a thing of the past. It may be due to the sense of invulnerability that many young people have. It surely is a result of a dreadful lack of information. But whatever the causes, a recent CDC report is deeply alarming: more than a quarter of all new HIV infections in the United States occur in people from ages 13 to 24. Each month, 1,000 teens and young adults become infected with HIV. Gay or bisexual youths remain at particular risk: in 2010, as many as 72% of the 12,000 new infections in the 13-to-24 group occurred among males who have sex with males. African American youth account for nearly half the new infections. And most young people who are HIV-positive don’t know it; despite recommendations by the CDC and the American Academy of Pediatrics that screening for HIV start in the early teens, only about one in five sexually active high schoolers has been tested. Only about one in three young adults in the 18-to-24 range has. In response, the CDC is funding a program to target at-risk young people and to address the related issues of stigmatization and homophobia. Certainly the new statistics will add urgency to the ongoing discussion about HIV screening recommendations.

New Assays

Nanosphere receives FDA clearance to market an NAT for detection of CYP2C19 mutations affecting drug metabolism. The U.S. Food and Drug Administration (FDA)  has granted 510(k) clearance permitting Northbrook, IL-based  Nanosphere to market its CYP2C19 Nucleic Acid Test on the automated sample-to-result Verigene® System. The Verigene CYP2C19 Test is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. The test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient’s whole blood sample in less than 2.5 hours. The Verigene System is a molecular diagnostics platform capable of performing tests for genetic, infectious disease, and protein targets on a single sample-to-result platform. In April 2011, the CYP2C19 Test received the CE IVD Mark for distribution in Europe and all countries recognizing the CE Mark.

FDA grants clearance to Diazyme to market a new biomarker for kidney disease. La Jolla, CA-based Diazyme Laboratories has been granted 510(k) clearance by the FDA to market its Cystatin C POC Test Kit on the SMART Point of Care System. The Cystatin C POC Test Kit is the first to employ this emerging biomarker, which its manufacturers say offers greater sensitivity than standard tests of kidney function in the early detection of acute and chronic kidney disease. The test can be run from a whole blood sample obtained in a physician's office, hospital, or clinic and delivers results in minutes. Other assays now available for the SMART Point of Care System include HbA1c for monitoring diabetes control as well as high sensitivity CRP, an emerging marker of inflammation which studies suggest is of value in stratifying risk of cardiovascular disease and stroke.

New Studies

Clinical results show that the experimental agent ibrutinib is highly active in CLL patients. Updated results from a Phase Ib/II clinical trial indicate that a novel therapeutic agent for chronic lymphocytic leukemia (CLL) is highly active and well tolerated in patients who have relapsed and are resistant to other therapy. The agent, ibrutinib (PCI-32765), is the first drug designed to target Bruton’s tyrosine kinase (BTK), a protein essential for CLL-cell survival and proliferation. Findings were presented last month at the American Society of Hematology Annual Meeting in Atlanta.

The study found that response to therapy was high across cohorts, with 71% of previously untreated older patients experiencing a complete or partial response at either treatment dose (420mg and 840mg). The same response was observed in 67% of relapsed patients and 50% of the high-risk patient cohort. After 22 months, the disease had not progressed in 96% of previously untreated patients and 76% of relapsed and high-risk patients.

“These findings are truly exciting because they demonstrate ibrutinib’s potential as a highly active, well-tolerated first-line therapy for CLL that produces a high rate of durable remissions,” says study co-leader John C. Byrd, MD, director of the division of hematology at Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital. “The drug is effective in part because patients are willing to stay on treatment since the side effects are very tolerable.”

Genetic Testing

New genetic test may improve value of prenatal testing. A large, multi-center clinical trial led by researchers from Columbia University Medical Center (CUMC) offers evidence that a new genetic test results in significantly more clinically relevant information than the current standard method of prenatal testing. The test uses microarray analysis to conduct a more comprehensive examination of a fetus’s DNA than is possible with the current method, karyotyping—a visual analysis of the fetus’s chromosomes. Results were published in The New England Journal of Medicine.

The prospective, blinded trial included 4,400 patients at 29 centers nationwide. The study involved women with advanced maternal age and those whose fetuses were shown in early screening to be at heightened risk for Down syndrome, to have structural abnormalities (as seen with ultrasound), or to have indications of other problems. The trial found that microarray analysis, which compares a fetus’s DNA with a normal (control) DNA, performed as well as karyotyping in identifying common aneuploidies (an abnormal number of chromosomes—an extra or missing chromosome causes genetic disorders such as Down syndrome and Edwards syndrome); it also identified additional abnormalities undetected by karyotyping.