Pre-Packed: Roche Arrives in Molecular POC with IQuum Acquisition

Pre-Packed: Roche Arrives in Molecular POC with IQuum Acquisition

Count Roche among the IVD leaders zeroed in on molecular point-of-care (POC) diagnostics. The global IVD giant recently announced its acquisition of IQuum, a company that bolsters Roche’s “molecular diagnostics offerings…that serve the point of care segment.”  The $450 million deal comes in the wake of similarly minded acquisitions of BioFire Diagnostics by bioMérieux (January 2014) and PathoGene by DxNA (January 2014). The true targets behind these acquisitions are hard to miss: over $20 billion of combined revenue in the global POC diagnostics and molecular infectious disease test markets. The market potential of molecular POC diagnostics is broad and limited only by the technology’s ability to displace more traditional infectious disease testing methods (microbiological tests and immunoassays) and the development of markets worldwide where lab resources are lacking and rapid, ease-of-use, accurate near-patient testing is a major clinical need.

While the IQuum acquisition has come only recently, Roche Diagnostics’ engagement with molecular POC diagnostics is longstanding through smaller ventures. Roche pursued technological antecedents as early as 1997, when it began licensing BioFire Diagnostics’ (then Idaho Technology) LightCycler rapid-cycle PCR technology. In November 2009, Roche entered into an agreement to identify applications and customers for Ionian Technologies and its “field-deployable” isothermal nucleic acid amplification technology and 10 minutes-to-result NEAR assay. In the same month, Ionian received an extended agreement with the Bill and Melinda Gates Foundation for the development of infectious disease tests to be used in the developing world. Through its venture fund, Roche also participated in Curetis AG’s financing round in April 2012. Curetis developed the Unyvero System that uses disposable cartridges to perform all molecular assay steps for infectious disease testing.

In The Market and Potential for Molecular Point of Care Diagnostics, Kalorama Information identified five primary market opportunities in infectious disease testing: healthcare-associated infections (HAIs); influenza and other respiratory tract infections; sexually transmitted diseases (STDs); sepsis; and infectious disease threats of the developing world. IQuum has so far targeted three of these markets through the market introduction of assays for influenza (FDA-approved A/B assay and a RUO-only H1N1 assay) and the development of assays for HIV, herpesviruses, dengue, and influenza subtypes.

In Roche, IQuum finds an effective partner with the network and resources to penetrate and develop markets for near-patient and POC molecular diagnostics in the developing world. Such market applications come in addition to the potential of IQuum’s moderate complexity, rapid molecular platform in the United States and other developed markets. The company’s benchtop analyzer and lab-in-a-tube (Liat) tests are ideal for near-patient settings with results in 20 minutes and pre-packed reagent test tubes with compressable compartments that contain and facilitate the multiple steps of a molecular assay.