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Dx Focus: PEPFAR Funding Drives Cepheid TB Test Uptake; Curetis Starts US Trials for MDx System


The United States President's Emergency Plan for AIDS Relief, or PEPFAR, this week announced it would provide $11 million in funding for as many as 150 Cepheid GeneXpert systems and 450,000 MTB/RIF test cartridges in 14 high-burden countries in sub-Saharan Africa and Burma.

The United States Agency for International Development and the US Centers for Disease Control will implement the funding, which is expected to help accelerate access to the Xpert MTB/RIF assay in countries with a high burden of TB/HIV infection. The funding will also be used to train health workers to use the device and support ministries of health to integrate the platform into national laboratory strategies, PEPFAR said.

PEPFAR made the announcement following the Nov. 29 launch of its Blueprint for an AIDS-free generation and in conjunction with the first annual meeting of the African Society of Laboratory Medicine in South Africa. The PEPFAR Blueprint is a document outlining specific action steps toward creating an AIDS-free generation.

Xpert MTB/RIF is a fully automated nucleic acid assay that can detect Mycobacterium tuberculosis DNA and mutations associated with rifampin resistance directly from sputum samples in less than two hours.

In August, under a separate initiative, PEPFAR and USAID partnered with UNITAID and the Bill and Melinda Gates Foundation to buy down the cost of Xpert MTB/RIF from about $17 to around $10 in high-burden countries (PCR Insider, 8/9/2012).

PEPFAR said that it has thus far invested in more than 275 Xpert instruments in such countries.

Germany's Curetis has commenced a clinical trial of its Unyvero system and lower respiratory tract assay in the US in the hopes of submitting a 510(k) application to the US Food and Drug Administration in 2014.

The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection, as well as several hundred retrospective samples with known microbiology culture results for rare pathogens.

Samples will be processed by the Unyvero Lysator sample prep platform, transferred to the LRT assay cartridge, and run on the Unyvero Analyzer — a benchtop, touchscreen, nucleic acid testing platform that combines proprietary universal sample prep with cartridge-based endpoint PCR and array-based detection. The primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to the gold standard of microbiology culture and to a composite reference diagnosis incorporating PCR and sequencing.

Trial sites include Northwestern University and North Shore-LIJ Health System. Christine Ginocchio, senior medical director and chief of the Division of Infectious Disease Diagnostics at North Shore-LIJ Health System, will serve as principal investigator on the trial. Curetis said that it has contracted Aptiv Solutions as its CRO and Neil Mucci of Global BioClinical as project manager in the US.

The LRT assay analyzes 39 DNA targets simultaneously from a single patient sample and provides results in about four hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the US; while resistance genes were chosen by frequency and clinical significance, Curetis said.

A similar product, the Unyvero P50 pneumonia cartridge, was CE marked in May and is currently marketed in Europe and the Middle East (PCR Insider, 5/17/2012).

Curetis said that it expects to complete enrollment for the clinical trial in the next 12 to 15 months.

In September, Curetis said that it had signed an agreement with technology group Heraeus Medical to jointly develop a cartridge for use on Curetis' Unyvero system to detect pathogens and antibiotic resistance in implant and tissue infections (PCR Insider, 9/30/2012).