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FIND Collaborates with Multiple Firms on MDx Tests for TB

NEW YORK (GenomeWeb) – The Foundation for Innovative New Diagnostics is collaborating with multiple firms to accelerate the development of low-cost molecular diagnostics for tuberculosis and drug resistance determination, the non-profit organization said today.

First, FIND said that it has established an initiative called "Support for Success" (S4S), the aim of which is to spur the development and uptake of promising TB diagnostics in low-resource countries. FIND has selected Indian firm Molbio Diagnostics as its first S4S partner, and will provide the company with technical assistance and resources to help commercialize Truenat, a rapid, portable, and affordable real-time PCR platform, and an accompanying molecular TB test.

In addition, FIND and QuantuMDx are partnering to develop technology for the combined detection of TB and drug susceptibility determination for the causative agent of the disease. This technology development deal will focus on QuantuMDx's handheld Q-POC device, which is anticipated to detect on the molecular level "an extensive set of genetic markers" and reduce the time for full antimycobacterial resistance profiling from about one week to less than half an hour, the organizations said.

QuantuMDx's nanowire technology allows researchers to interrogate the entire bacterial genome and to detect specific markers. It also is being developed to perform genetic sequencing on the same technology platform. FIND is supporting the development of an integrated sample handling compartment, while QuantuMDx continues to develop the platform for Q-POC.

Separately today, Cepheid said that it is collaborating with FIND and Rutgers New Jersey Medical School to develop a next-generation test for Mycobacterium tuberculosis.

The test, called Xpert MTB/RIF Ultra, is being developed to have increased sensitivity to detect patients with smear-negative TB, which is often associated with HIV co-infection. The National Institute of Allergy and Infectious Diseases has also awarded the researchers, headed by David Alland, a professor and chief of the division of infectious diseases at the Center for Emerging Pathogens at Rutgers, a grant in support of the work, as PCR Insider reported in April.

The collaboration will leverage Cepheid's GeneXpert System, more than 7,500 of which are placed globally, including more than 3,500 in 110 low-resource countries under Cepheid's High-Burden Developing Country program. Xpert MTB/RIF Ultra will run on existing six color GeneXpert Systems and is expected to be provided to HBDC markets at the same price as Xpert MTB/RIF, the partners said. The new test is anticipated to be available to the HBDC market in the first half of 2016.

The partners said that because target DNA in patient samples with early stage TB is at levels that elude detection, current tests have difficulty detecting the disease. To solve this problem, they plan to leverage Cepheid's cartridge-based nested PCR amplification capability to amplify patient DNA samples to a level where they can be detected more accurately.

The Xpert MTB/RIF test has a limit of detection of 130 cfu/ml. For the Xpert MTB/RIF Ultra test, Cepheid will employ new technologies, including a larger DNA reaction chamber in the cartridge, to bring the limit of detection down 10-fold to about 10 cfu/ml across all strains, a level that the partners said is similar to or better than liquid culture.

"The low sensitivity of smear microscopy limits its impact on TB control," FIND CEO Catharina Boehme said in a statement. "Xpert MTB/RIF Ultra has great potential to transform the way we diagnose the 3 million people who every year fail to receive TB testing or treatment."

Cepheid also is developing a test to specifically call out extensively drug-resistant (XDR) tuberculosis, a form of multidrug-resistant TB that is resistant to the most potent TB drugs — isoniazid, rifamplin, aminoglycosides, and any fluoroquinotone.

FIND is a non-profit organization supporting the development of diagnostic tests for "diseases of poverty," including malaria, sleeping sickness, hepatitis C, leishmaniasis, and Chagas disease, as well as TB.