CAP TODAY
According to CAP Today, the platform and molecular kits "handily outstrip traditional identification and antibiotic susceptibility testing" for bloodstream infections. See Anne Paxton's article here.
PubMed
Besides CAP Today, there have been a flurry of recent articles about Accelerate Pheno on PubMed (Charnot here, Marschal here, Pantel here, Elliott here, Lutgring here).
Financials
Accelerate Diagnostics (symbol AXDX) is based in Tucson. According to Yahoo Finance, today's market cap is $1.1 billion. Share price, $21 today, has been in the $18-26 range for several years. 2017 revenue was $4M with a $64M operating loss. See a recent quarterly transcript at Seeking Alpha, here. One financial blogger discusses the company here. Company website here.
FDA
See an FDA press release from February 2017 here, which is a good entry point for understanding the test design and positioning. For more technical detail, see the FDA De Novo 510(k) decision summary here, reclassification order here, DEN160032. The FDA reviewed a primary clinical study of 1850 positive blood cultures, using slower traditional methods as a gold standard.
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Bay Area molecular diagnostics company Karius is working on rapid detection of 1250 pathogens as an NGS based reference lab test; here. It raised $50M ten months ago in August 2017, here. Bay Area startup mFluiDx is working on rapid POCT molecular diagnostics; here.
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In a talk at ASM June 2018, quoted in Genomeweb, Biomerieux's Alex Van Belkum noted that current approaches to AST are accepted and cheap, and that sequencing based AST has "a long way to go." Here.
