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Abbott Discontinuing Current Version of Plex-ID PCR System for Smaller Platform Under Development

Abbott is discontinuing the current version of the Plex-ID system as it prepares for market a next-generation system intended to be smaller and easier to use, and thus more conducive to a clinical diagnostics setting.

Abbott's Plex-ID system is based on technology that the company acquired along with Ibis Biosciences in 2009. The platform combines automated sample preparation, broad PCR amplification, and electrospray ionization mass spectrometry of DNA amplicons to identify base composition based on molecular weight. The company generally refers to the core underlying technology as PCR/ESI-MS.

In general, the system can be used to screen and identify bacteria, viruses, fungi, and protozoa by comparing assay results to a library of more than 750,000 entries; perform high-resolution subtyping; identify known virulence markers and antibiotic resistance genes; and identify mixtures of microbes direct from a single sample.

According to the company's website, Plex-ID can analyze as many as 250 samples per day and can produce results within 8 hours, from sample preparation to identification.

Both Ibis and Abbott had early success selling the platform into applied markets, such as biodefense, but in recent months the company and its collaborators have published multiple peer-reviewed studies and presented at scientific conferences on the clinical diagnostic potential of Plex-ID.

For instance, in April at Cambridge Healthtech Institute's "Innovative Sample Prep & Target Enrichment in Clinical Diagnostics" in Newport Beach, Calif., Mark Eshoo, director of new technology development at Abbott, disclosed that the company was working on a Plex-ID assay to detect and genotype Borrelia burgdorferi, the bacterium responsible for causing Lyme disease in humans.

And in August, researchers from Johns Hopkins University reported that their high-resolution melting assay and a Plex-ID assay performed similarly in identifying pathogens from a cohort of positive blood culture samples — with the Plex-ID scoring particularly high marks in terms of throughput, automation, and sensitivity.

In addition, in March Abbott and Dallas-based Genetics Laboratory said they were co-developing a molecular test designed to rapidly detect microorganisms that cause orthopedic infections.

Abbott in April received CE marking in the European Union to market its Plex-ID platform along with three assays: Plex-ID Viral IC Spectrum, Plex-ID BAC Spectrum BC, and Plex-ID Flu.

And, in addition to the BAC Detection and Broad Fungal assays used in the aforementioned studies, Abbott offers a variety of Plex-ID assays for microbial identification for research use only, including tests for biothreats, Clostridium difficile, food-borne illnesses, methicillin-resistant Staphylococcus aureus, and multi-drug resistant tuberculosis.

During his presentation at the CHI conference in April, Abbott's Eshoo indicated that the company was at least looking into seeking approval from the US Food and Drug Administration for Plex-ID.

However, this week Abbott confirmed that it is planning to discontinue the current version of Plex-ID in favor of a next-generation system that would be more conducive to clinical implementation. The current Plex-ID platform has been reported by users to cost in the range of $750,000, and the instrument is about the size of a large refrigerator, making it ill-suited for use in most clinical diagnostic laboratories.

An Abbott spokesperson confirmed that the company was developing a next-generation version of Plex-ID, but did not elaborate. It is unclear whether Abbott will discontinue the current platform in both Europe and the US; or whether the company plans to seek FDA approval for a newer version of the system.

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