NEW YORK (GenomeWeb) – A collaboration between Johnson & Johnson subsidiary Janssen Diagnostics and Biocartis has so far yielded three prototype infectious disease assays for Biocartis' Idylla molecular diagnostics platform.
Scientists from Janssen presented tests for hepatitis C viral load, influenza A/B and RSV, and influenza surveillance at last month's Clinical Virology Symposium in Daytona Beach, Florida. Preliminary assessments of the assays described high specificities and lauded the ease of the cartridge-based Idylla system.
Biocartis also recently announced it is developing an assay for Ebola in collaboration with Janssen, with the hopes of achieving Emergency Use Authorization from the US Food and Drug Administration.
In addition to Ebola, the three new tests described at CVS are some of the first infectious disease assays that Biocartis will put on Idylla, Rudi Pauwels, CEO and founder of Biocartis told GenomeWeb in an interview.
"We intend, subject to successful trials and testing, to commercialize these first in Europe as CE marked tests, and then they will go the 510(k) route in the US," Pauwels said.
The Idylla platform is a fully automated, random-access system that combines all the workflow steps of quantitative real-time RT-PCR — from sample preparation through detection — and uses pre-loaded, disposable cartridges. Prototype assays presented at the symposium were tested using a diverse array of samples, such as whole blood, plasma, nasopharyngeal (NP) swabs, and virus cultures.
The hepatitis C viral load test is designed for viral quantification in infected individuals being treated with antivirals.
"This test is also important for the entire Idylla program because it is the first fully quantitative assay that we have demonstrated on the platform, and it's going to be the benchmark and example for other viral load tests that we are planning to bring on," said Pauwels.
The prototype HCV assay takes 2.5 hours. It was tested with high-titer patient samples serially diluted in whole blood and plasma panels, as well as a commercial plasma panel, to determine specificity, linearity, and limit of detection of the test.
Pauwels emphasized that the assay's sensitivity was high at 13 units per ml, with a large dynamic range.
Twenty paired sets of whole blood and plasma from infected patients were also tested and compared to an unnamed FDA-approved molecular test, with 100 percent positive agreement, 96 percent correlation in plasma, and 94 percent correlation in whole blood.
Pauwels said this test is realistically targeted to launch in 2017, but the data so far is "very encouraging."
Influenza and respiratory tests, meanwhile, are important since collaborator Janssen and parent company J&J are "particularly active in those areas."
The flu/RSV test should be launched next year, but the exact timing may depend on how the safety analysis and testing goes in the coming months, Pauwels said.
As described in the symposium presentation, the 50-minute test detects the H1N1, 2009 H1N1, and H3N2 strains of influenza A, as well as the H275Y mutation conferring Tamiflu resistance. It also detects influenza B, RSV A, and RSV B. The test had a low limit of detection across analytes and did not cross react with cultures of 13 other viruses and 11 bacteria.
Further, compared to culture, direct fluorescent antibody, and PCR assays, preclinical data from 100 NP swabs showed 100 percent positive agreement for all targets. There was also 100 percent negative agreement for all influenza targets, while that for RSV A and B was about 99 percent and 98 percent, respectively.
"A big advantage for clinicians is that [the test] works directly with a nasal or nasopharyngeal swab, which goes straight in the cartridge," Pauwels noted.
Finally, the pandemic flu surveillance assay is being fine-tuned in collaboration "with government labs in some countries in Asia," and the timing of launch may depend on work done in the coming months.
The assay targets influenza B, the H1 and H3 subtypes of influenza A, H1N1, and avian influenzas H5N1 and H7N9. The reported data showed no cross reactivity with other viral and bacterial cultures, and the test correctly reported small sets of samples positive for each analyte. The poster also concluded that the Idylla platform's all-in-one cartridge format "makes it an attractive option for influenza surveillance, diagnosis, and outbreak resolution."
The Janssen Pharmaceuticals and Biocartis partnership dates to early 2011. The studies presented at CVS were done by researchers at Janssen Diagnostics, a branch within Janssen Pharmaceuticals R&D that was established in February 2012.
But Pauwels emphasized the companion diagnostics nature of the work with Janssen. "It has always been from the beginning a pharma-related collaboration, and this is another example of how pharma increasingly incorporates diagnostic testing," he said.
Janssen Pharmaceuticals last year licensed VX-787, an influenza A viral polymerase inhibitor that is now in Phase 2b clinical trials. The firm's HCV protease inhibitor Olysio (simeprevir) was approved by the FDA in 2013, and it also has another collaboration to develop sequencing-based HCV patient screening.
Biocartis and Abbott have also teamed up to develop companion diagnostics, and Pauwels said the collaborators have been contacted by "quite a few" pharmaceutical and biotech companies already.
A previous Biocartis partnership to develop and commercialize Idylla with BioMérieux ended when that firm acquired BioFire Diagnostics. Biocartis has also previously partnered with Microbiome to develop a sepsis test, and with SpeeDx to develop an 18-plex KRAS-BRAF assay.
The Janssen/Biocartis Ebola test will be submitted to the FDA this year and it will be part of an additional product offering Biocartis is planning in the area of disease surveillance, Pauwels said, adding that the firm will communicate more details on this in the future.