Rapid Infectious Disease Testing Picks Up Speed

Several recent events highlight an increase in the pace of innovation in rapid infectious disease testing. In July, Accelerate Diagnostics Inc. filed a De Novo request to the US Food and Drug Administration for Evaluation of Automatic Class III Designation of its system for pathogen identification and antibiotic susceptibility testing (AST). A week and a half earlier, Cepheid obtained clearance from FDA for expanded claims to its Xpert Carba-R test for detecting carbapenem resistance genes in multidrug-resistant organisms using rectal swabs in addition to bacterial isolates, significantly cutting testing time. Two months earlier, Luminex Corp. completed a tender offer for bloodstream infectious disease test specialist Nanosphere Inc. for $77 million. [See Deal] Also in May, the Merck Global Health Innovation Fund (Merck GHI) increased its investment in OpGen Inc. to help fund OpGen’s bioinformatics-heavy platform for infection detection and control. [See Deal] These moves after Roche drew attention to the space last summer when it paid $190 million up front and promised another $235 million in product-related milestones for GeneWEAVE Biosciences Inc. and its platform for rapidly detecting multidrug-resistant organisms and analyzing AST or resistance. [See Deal]

“There has been a lot of investment in product development in microbiology, defined broadly to include molecular products that sit within the microbiology continuum,” says William Quirk, managing director at Piper Jaffray. The interest mirrors automation trends ongoing in diagnostics for the better part of the last 15 to 20 years