Diagnostic Testing & Technology Report

Results of direct-to-consumer (DTC) genetic tests are “misleading and of little or no practical use” to consumers, concludes a new report by the Government Accountability Office (GAO). The report was released on July 22 during a hearing on DTC testing before the House Subcommittee on Oversight and Investigations.

Officials from the U.S. Food and Drug Administration (FDA) did much more listening than talking during the two-day public meeting on laboratory-developed tests (LDTs) convened by the agency July 19-20 in Hyattsville, Md. However, it rapidly became clear to the more than 600 people in attendance that it is not a question of if the FDA will exercise its authority over LDTs but when and how. “There are a lot of gaps in the regulations,” said Alberto Gutierrez, Ph.D., director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety. “Probably the biggest gap of all is clinical validity.” While clinical validation is among the FDA requirements for regulation of in vitro diagnostics (IVDs), CLIA requires only analytical validation.

Iris International (Chatsworth, Calif.), which manufactures automated in vitro diagnostics systems and consumables for use in clinical laboratories worldwide, has agreed to acquire privately held AlliedPath (San Diego). Iris will pay $4.7 million in cash for the cancer-focused molecular diagnostics laboratory, with an additional $1.3 million payable upon the achievement of specific sales and earnings targets over the next three years. The deal is expected to close by July 30.

Collaboration and coordination are the keys to reducing costly diagnostic errors, according to an article published in the July 28 issue of the Journal of the American Medical Association. In their commentary, Mark Graber, M.D., of Stony Brook University Medical Center, and Hardeep Singh, M.D., M.P.H., of Baylor College of Medicine, discuss a unique model of primary care, called the patient-centered medical home, and outline five key principles to reduce the incidence of diagnostic errors: Right Teamwork, Right Information Management, Right Measurement and Monitoring, Right Patient Management, and Right Safety Culture.

Axela (Toronto), which develops systems for multiplex analysis of protein biomarkers, has acquired Xceed Molecular (Toronto and Wellesley, Mass.), which is also focused on translating research discoveries into clinical diagnostic tools. The deal is expected to accelerate Axela’s introduction of novel multiplex biomarkers for diagnostics. Financial terms of the transaction were not disclosed.

As the line between laboratory-developed tests (LDTs) and medical devices subject to premarket regulatory review has grown ever blurrier, the U.S. Food and Drug Administration (FDA) recently announced its intention to move to a risk-based application of LDT oversight. How that goal will be accomplished remains to be seen, but the agency heard a variety of suggestions, concerns, and frustrations at the two-day public meeting it convened on July 19 in Hyattsville, Md.

A morning urine test is superior to all other tests for detecting declining kidney performance in patients with diabetic kidney disease, according to a study published on July 15 in the online version of the Journal of the American Society of Nephrology. The results suggest that the best available approach to monitoring kidney function is by measuring the albumin-to-creatinine ratio from a first morning urine sample.

The U.S. Food and Drug Administration has cleared for marketing the Prodesse ProFast+ assay, a molecular diagnostic test that can detect and differentiate among three common influenza A virus subtypes: seasonal A/H1, seasonal A/H3, and 2009 H1N1. The test is manufactured and marketed by Gen-Probe (San Diego), which acquired Prodesse in October 2009 for approximately $60 million plus potential milestone payments of up to $25 million.

A study published in the June issue of Clinical Chemistry found that seven leading commercial methods of directly measuring cholesterol levels produce results of mixed accuracy when compared to ultracentrifugation reference measurement procedures, which are used as the basis for clinical guidelines.

Genetic analysis company Illumina (San Diego) has acquired Helixis (Carlsbad, Calif.), a developer of high-performance, low-cost, real-time polymerase chain reaction (PCR) systems, for $70 million in cash and up to $35 million in payments contingent upon the achievement of revenue-based milestones through the end of next year. Helixis CEO Alex Dickinson has joined Illumina as senior vice president of PCR Solutions.

On July 13, the Centers for Medicare and Medicaid Services (CMS) issued two final rules to implement a program to incentivize physicians and hospitals to adopt and make “meaningful use” of certified electronic health record (EHR) technology. The meaningful use rule specifies the objectives that providers must meet in payment years 2011 and 2012 to qualify for incentive payments. The certification rule specifies the technical capabilities that EHR technology must have to be certified and to support providers in meeting meaningful use criteria.

The G-2 Diagnostic Stock Index fell less than 1 percent in the three weeks that ended July 23, with 10 stocks up in price and eight down. The G-2 index is down by 10 percent since January, while the S&P 500 has dropped 4 percent and the Nasdaq is off 2 percent over the same period.

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius has announced 15 awards totaling $9 million to support preventive medicine residency programs at accredited schools of public health, schools of medicine, and hospitals. Of these funds, nearly $6.7 million is part of the $200 million appropriated to HHS’ Health Resources and Services Administration (HRSA) under the American Recovery and Reinvestment Act of 2009 to address the nation’s health care workforce shortages.