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...