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BioInnovation Solutions, Enzymatics Validate Isothermal Ebola MDx on West African Outbreak Samples

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NEW YORK (GenomeWeb) – Applied sequencing firm BioInnovation Solutions has partnered with reagents and assay manufacturer Enzymatics to develop a rapid Ebloa test that uses isothermal amplification.

The partners said today that they have clinically validated the new assay in a trial using patient samples in Nigeria, the first time a rapid Ebola test has been validated using clinical samples from the current outbreak in West Africa.

The trial was conducted at the African Center of Excellence for Genomics of Infectious Diseases (ACEGID) at Redeemer's University in Mowe, Nigeria, between Nov. 7 and Dec. 5, Christian Happi, director of ACEGID told GenomeWeb in an email.

The validation study included a range of samples. Among them was "the index case and other positive cases of the Nigerian Ebola outbreak of July to September 2014," Happi said.

"There is a good correlation between this test result and the RT-PCR data," he added.

The Ebola outbreak in Nigeria affected 19 people, seven of whom died, but it was quickly contained, according to the World Health Organization.

The major advantages of the new assay, called the Rapid Response Ebola Test, or RRET, are its 30-minute turnaround time and that it only requires 15 microliters of blood to perform, Happi noted. In addition, the test is field-deployable "and does not require sophisticated equipment and highly specialized training, like the conventional RT-PCR," he said. 

The test can also be used on urine samples, and shows a result within 15 minutes of extraction, according to the statement.

These advantages could prove very valuable, because speed and accuracy in Ebola virus diagnosis "are key factors for effective control of the current Ebola outbreak in West Africa," said Happi. 

Yemi Adesokan, founder of Lausanne, Switzerland-based BioInnovation Solutions, said in an email that the firm's goal is "to have the RRET deployed to the areas of need, specifically ports of entry, in the coming weeks in anticipation of the holiday travel season."

The rapid molecular assay relies on isothermal amplification, the companies said in their statement. 

"Unlike PCR-based technologies that require the purchase of a thermocycling instrument as well as the availability of a stable electricity source, the BioInnovation RRET only requires a water bath," the statement said.

Adesokan confirmed that the isothermal assay runs in a reaction tube at a temperature of 60° C, and said the firm will disclose details about the isothermal technology at a future date.  

BioInnovation Solutions recently relocated and rebranded from its former name of Pathogenica. It develops pathogen detection and bio-surveillance technologies that use next-generation sequencing and informatics analyses. The firm announced last month that it will develop a next-generation sequencing panel for filoviruses in collaboration with the US Army Medical Research Institute of Infectious Diseases. The company's experience with filoviruses has enabled its creation of the RRET assay, today's statement suggested.

As Pathogenica, BioInnovation Solutions received CE-IVD marking for a hospital-acquired infection pathogen detection kit called HAI BioDetection. That kit was launched in 2012 in partnership with Life Technologies (now Thermo Fisher Scientific) and compared well with the standard method used to type multi-drug resistant Escherichia coli in a recent study in Holland. Thermo Fisher and Illumina had co-marketing agreements with Pathogenica for the BioDetection HAI kit, but are no longer marketing it, as previously reported.

Meantime, Enzymatics has begun commercializing targeted sequencing technology based on anchored multiplex PCR, or AMP, originally developed by ArcherDx. Reagents for these tests are lyophilized, and the firm's first product is for the detection of cancer-related gene fusions from RNA. 

While many firms are considering pursuing Emergency Use Authorization for Ebola assays from the US Food and Drug Administration, Adesokan did not disclose whether RRET would go this route as well. 

However, the RRET assay adds to a growing list of Ebola diagnostics attempting to move beyond standard lab-based RT-PCR. For example, a recently announced partnership between IDT and Ubiquitome aims to create a handheld, EUA-approved test, while BioFire Defense recently received EUA for two FilmArray Ebola tests. Lucigen, meanwhile, is developing a handheld isothermal assay and will also seek EUA.

The results of the validation study of RRET will be published at a future date, Happi said.

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