Microbiology Diagnostics Is Alive and Well - Beckman Coulter Adds to its Core Testing Solutions

Microbiology Diagnostics Is Alive and Well - Beckman Coulter Adds to its Core Testing Solutions

The following analysis is derived from Kalorama Information’s upcoming report on the global infectious disease test market. The report’s prior edition, The Worldwide Market for Infectious Disease Diagnostic Tests, is also available.

This post discusses the potentially undervalued move by Beckman Coulter to enter the market for traditional microbiology diagnostics or ID/AST systems at a time when many mid-sized and major IVD companies have focused on molecular diagnostic methods. Similarly auspicious industry moves in the microbiology diagnostics space will be covered in following posts.

Industry observers have long speculated on whether the introduction of clinical molecular diagnostics would erode the core and traditional role of the culture in infectious disease testing. In 2002, Kalorama Information echoed the then-prevalent industry opinion - based equally on technological optimism as on the limitations of traditional cultures - that molecular assays could replace manual and automated ID/AST systems:

Industry experts predict that the longevity of ID/MIC systems-manual or automated, in the developing and developed world-may be limited. It is expected that by 2010 at the latest, traditional methods for routine culture and sensitivity testing will be replaced by molecular assays.

This belief was long-held. Even prior to the development of polymerase chain reaction (PCR) as a clinical assay technology, one microbiologist recalls reading an article in the late 1970s that predicted the dethroning of the culture ID/AST workflow by 1990. Clinical demand has indeed encouraged the introduction of new diagnostic technologies and the expansion of their role in infectious diseases, but into 2015 cultures and other cell assays remain alive and well in the market. Most telling of culture and cell assay testing’s (hereafter referred to as ID/AST) enduring market prospects have been two recent acquisitions by IVD majors - the first of which is profiled in this post.

Beckman Coulter announced its acquisition of Siemens Healthcare Diagnostics’ clinical microbiology business in 2014, including the industry-respected MicroScan automated ID/AST instrument. Finalized in early 2015, the acquisition provided Beckman Coulter - one of the leading suppliers of core lab automated instrument systems in the world - with a complete microbiology solution to rival its competitors:

  • Automated ID/AST with the MicroScan WalkAway instrument
  • Semi-automated low-volume ID/AST with the MicroScan autoSCAN-4 instrument
  • Microbiology sample processing automation with the third-party Copan WASP system
  • Pre-analytical automation including culture incubation and imaging with the third-party Copan WASPLab system
  • Rapid microbiological ID testing with the third-party Bruker MALDI-TOF-MS system

Beckman’s new microbiology solution heavily automates microbiology specimen processing through ID/AST testing procedures and matches microbiology competitors’ workflow solutions such as bioMérieux’s Copan-PREVI-VITEK 2-VITEK MS combination and Becton, Dickinson & Co.’s (BD) InoculA-WCA-Phoenix-Bruker MALDI Biotyper combination. Meanwhile, Siemens Healthcare Diagnostics’ equally conspicuous exit from ID/AST testing can be interpreted through its parent company’s desire to streamline its diagnostics business prior to a potential divestiture or spin-off.

The workflow solutions outlined above will stave off the once-predicted decline of ID/AST testing by serving as effective responses to the pressures facing culture-based microbiology. Heavy automation of ID/AST has been in response to lab technician and lab microbiologist labor shortages, rather than competitive pressure from molecular diagnostics. Clinical labs, especially hospital microbiology labs, are desperately seeking cost savings and can achieve them in part through reduced personnel costs. Microbiology automation can also indirectly affect savings for a hospital by improving the efficiency and quality of testing to improve patient outcomes.

Rapidity of results or faster turnaround time for microbiological ID testing has been addressed by the incorporation of mass spectrometry (MS) analysis into clinical ID/AST workflows. So far, MS does not represent a competitive threat to culture and cell assay workflows, but rather an adjunct: clinically approved MS applications are limited to the testing of cultures rather than direct clinical specimens. Other rapid infectious disease tests are also oftentimes not in direct competition with ID/AST systems; the majority of ID/AST testing is for outpatients where molecular and immunoassays’ advantage in time to results is frequently irrelevant. Overnight or longer results can be acceptable even in inpatient cases where treatment does not need to be imminently implemented. Clinicians may also forego costly, presumptive rapid molecular testing when the severity of a patient infection does not warrant it.

Kalorama Information will cover the ID/AST market as part of the larger infectious disease test market in its upcoming market research report. The report’s prior edition, The Worldwide Market for Infectious Disease Diagnostic Tests, is also available.