CHICAGO (GenomeWeb) — Abbott continues to grow its molecular product line, previewing the next generation of its pathogen identification platform at the American Association for Clinical Chemistry annual meeting here this week.
Called Iridica, the platform is the latest iteration of a pathogen identification technology previously called Plex-ID. The core technology of the platform was originally acquired from Ibis Biosciences in 2009 for $215 million and has since been developed and enhanced.
The sample preparation unit for the Iridica system was previewed for the press in a private room at AACC. It was displayed atop an optional cabinet for consumables, but is designed to fit on a bench top. It can process up to six samples at a time, and requires 5ml of whole blood. It can also accommodate other sample types, such as plasma, sputum, bronchial lavage, or tissue.
Admittedly, the sample prep for Iridica is still a rate-limiting step for overall workflow, according to company officials.
Deepak Nath, president of Abbott Molecular, said in a presentation at the conference that the company has recently made significant advances in isolating miniscule amounts of pathogen DNA from a background of human DNA. He suggested customers requiring higher throughput could run parallel streams of sample prep using two separate modules to ameliorate this possible bottleneck. The entire platform would likely meet the pathogen detection needs of a 400-bed hospital, he said.
The five modules that comprise the Iridica platform are a bead-beater, a sample prep and extraction module, a thermocycler, a de-salter, and a custom-designed mass spectrometer.
Iridica can be run by a laboratory technician and has a total hands-on time of less than 30 minutes, Nath said. It provides results in 8 hours, and could be most applicable to a critical care setting, he added.
Importantly, the platform does not require any culturing of pathogens. This standard practice can take days for bacteria and up to several weeks for fungi. Iridica can also identify pathogens that are difficult to culture, such as anaerobic bacteria, or those that grow in biofilms.
Because it is a comprehensive and sensitive screen of many possible pathogens, Nath said that users would be able to confidently rule out most infectious agents if results are negative. The company has also made an effort to remove any error-prone steps, he said.
Like its predecessor, Plex-ID, Iridica uses universal primers to amplify bacterial, viral, or fungal nucleic acids. Mass spectrometry is then used to essentially weigh the products, and results are checked against a curated pathogen database.
Iridica currently differentiates between 600 bacterial families, as well as 200 families of fungi and 13 families of virus, Nath said. "We're able to essentially cover the entire tree of life of bacteria that infect humans," he said.
Michael Huiras, director of global marketing for Abbott's Ibis Bioscience division, said Abbott has conducted two usability studies with microbiologists and molecular technicians, and has also created a dedicated medical affairs team, as Iridica's fast results may require a change in clinical practice workflow.
He emphasized that Iridica can be used for detection of routine infections. However, the platform also enables identification of obscure and unculturable infections, which provides a "wow" factor that impresses some clinicians.
As reported previously by PCR Insider, the Iridica platform is currently being validated in a clinical trial in Europe.
In a preliminary report, the study – called Rapid Diagnosis of Infections in the Critically Ill (RADICAL) – retrospectively analyzed samples from 180 patients with suspected severe infections. The sensitivity for bloodstream infection and pneumonia assays was 88 percent and 91 percent, respectively, when compared to culture. The technology was also able to detect pathogens that initial culture missed in many patients, and Abbott noted that physicians on an adjudication panel would have changed their treatment plans in more than half of the cases had they had the Iridica data available.
The RADICAL study is expected to be completed in late 2014, and Iridica is expected to be available as a CE-marked in vitro diagnostic device in European countries within the next 12 months. The platform is currently designated for research use only in the US, and Abbott has not disclosed plans to pursue US regulatory clearance.
Abbott Molecular outlook
In a conversation with PCR Insider on the AACC floor, Nath noted that Abbott Molecular is "more than just Iridica."
"We have a position in infectious disease more broadly through our m2000 system and world class assays that have withstood the test of time in terms of performance relative to our competition," he said.
The firm also has a significant presence in fluorescent in situ hybridization. "That field is changing very rapidly with the onset of new technologies, NGS being the chief among them, but also multiplex PCR in the oncology applications is fundamentally reshaping the field," he said.
"Obviously, the more traditional [technologies] of FISH and IHC continue to need innovation and nursing from an R&D standpoint," Nath added.
He noted that the company recently announced an agreement with BioCartis regarding the use of multiplex PCR for companion diagnostics. "We have a good companion diagnostics business leveraging our technologies and capabilities in assay development across the different platforms," he said.
"We envision ourselves continuing to make investments in R&D in oncology, but clearly we're interested in being a stronger player over the long term and looking at all of our options relative to how the field is changing."
The company also has a genomics business in HLA testing through an agreement with Celera, Nath said. "That space, particularly for transplant, is going through significant changes, a lot of that is going from Sanger to NGS. We have to evaluate our options in the context of that shift," Nath said.
In terms of the m2000, Abbott's high-throughput nucleic acid detection platform, there are currently nine FDA-cleared tests on the menu.
In the US market, Abbott has the largest test menu on a single automated platform, according to Robert Kunkler, director of global strategic marketing for Abbott Molecular. The firm continues to add to that portfolio, most recently with an assay for syphilis, while overseas it recently launched a CE-marked tuberculosis assay.
"That assay will be the first mTB assay with automation from sample prep to sample results. It's got a unique feature for bio-safe handling on the instrument, an inactivation reagent that's used upfront," he said.
The mTB assay also offers 81 percent sensitivity in smear-negative TB versus culture, Kunkler added. This is higher than other systems on the market, he said. "We can also detect down to 17 Cfu/mL. That's significantly below what other mTB assays can do."
Abbott has a follow-on product in development that will test for refampicin and isoniazid resistance. "We believe [testing for resistance to] both of those front-line meds is needed to understand the resistance problem" in different countries, Kunkler said.
Kunkler also noted Abbott's efforts in emerging markets for HIV viral load testing. "There's significant capacity on the ground of m2000s throughout Africa and Southeast Asia" being used for HIV testing, he said.
"We believe this is a great tool for people who are trying to manage populations with 'the big three' – HIV, malaria, and TB."
In the case of HIV and TB co-infection, for example, sensitivity in smear-negatives becomes increasingly important.
"[For] these labs that are just learning how to do molecular, [the m2000] may be the only tool that they have," Kunkler said. Unlike other systems on the market designed to detect single pathogens, the m2000 provides clinicians a broad test menu, and assays for multiple pathogens can be run in the same batch.
The m2000 is equipped for direct loading of primary sample tubes, with no pipetting required. Different sample types – whole blood, serum, CSF, sputum, urine, or stool, for example – can be loaded onto the same run for simultaneous extraction.
The company has also been enhancing capability in using dried blood spots as samples for emerging markets, Kunkler noted. This is "another way to improve access to patient care," he said.
The m2000 platform uses bar coding to track samples and controls for cross-contamination using "no-fly zones" for the robotic arm. The high-throughput 96-well plate format runs controls and up to 93 samples in about five hours, Kunkler said.
The system also reuses tips when possible, to help users save on the cost of consumables. Master mixes for each specific assay are also bar coded, and the instrument automatically combines this with aluent from sample extraction, eliminating the need for pipetting. An end user then seals the plate and transfers it for amplification and detection.
The m2000 is described as a "walk-away system." Once the sample is loaded, the extraction step takes about two hours and subsequent detection takes around 3 hours. Up-front hands-on time is about 10 to 15 minutes.
Abbott also launched a product on the m2000 last year called mPlus, which enables more flexible batch sizes.
"We continue to enhance this platform," Kunkler said, adding, "We don't dead-end platforms, even though we are developing a next generation [one]. We think it's important that customers who invested in this know that they're going to get value out of it."