Major Developments and Exciting News to Share
360Dx.com article on Specific Diagnostics’ commercialization in Europe and the US.
“Specific is beginning its commercial activities in Europe starting in the fourth quarter of 2021 and plans to expand to the US next year, according to its CEO Paul Rhodes. With the addition of former GenMark Diagnostics CFO Johnny Ek to its executive team and Romney Humphries, former CSO of Accelerate Diagnostics, on its scientific advisory board, as well as study results and regulatory clearances, the firm hopes to become a major competitor in the AST space.”
“I’m very excited for the unique opportunity to join Specific Diagnostics,” said Mr. Ek. “I have witnessed first-hand the significant market demand for rapid diagnostics and the reception of Specific’s Reveal rapid AST instrument is no surprise to me.”
“We were pleased to see the Reveal system’s capability to detect and characterize resistance to antimicrobial agents which arises in the French hospital system,” said Dr. Laurent Dortet, Director of the Associate French National Reference Center for Antibiotic Resistance. “Reveal’s capability to phenotypically detect carbapenem resistance, regardless of the particular mechanism at play, will be of great relevance in addressing CRE (Carbapenem-resistance Enterobacteriaceae), surveillance of which is a central responsibility of our Centre.”
“I am pleased to join Specific’s Scientific Advisory Board at this exciting stage, when the Company’s rapid susceptibility testing product is being introduced across Europe and soon in the US,” said Dr. Humphries.
“We are honored to partner with a world leader as bioMérieux to bring the REVEAL Rapid AST system to microbiology labs across Europe,” said Paul A. Rhodes, Ph.D., CEO of Specific. “Every lab we encounter wants rapid, easy-to-use susceptibility testing at the right price; we couldn’t reach them all without partnering with an organization with the scale and quality of bioMérieux.”
“We are looking forward to participating in Canaccord’s 2021 Growth Company Conference,” said Dr. Paul A. Rhodes, Specific’s CEO. “With CE mark registration and our launch of the Reveal rapid AST system in Europe, and US clinical trials getting underway, Specific has a great deal to share with the diagnostics investor community.”
“Same-shift AST fills a major gap in the timely treatment of blood stream infections, and we are pleased
to be among the distinguished laboratories chosen to conduct FDA trials for this instrument,” agreed Dr.
Linoj Samuel, Division Head of the Clinical Microbiology Laboratory of the Henry Ford Hospital in Detroit.
“In the age of antibiotic resistance, alternatives to antibiotics are increasingly needed,” said Dr. Paul A.
Rhodes, Specific’s CEO. “While the Reveal instrument had proven its capability for rapid assessment of
antibiotic drug efficacy, we were excited to consider its efficacy as a bacteriophage platform.
“I’m truly looking forward to working with all of the distinguished KOL sites we are contracting with for our US clinical trials,” said Mr. Wehage. “Once FDA approved, I believe the Reveal will truly change the way US hospital systems manage and treat blood stream infections.”
“With our CE-IVD registration we continue to add more evaluation sites in France,” said Dr. Paul A. Rhodes, Specific’s CEO. “Erwan’s knowledge and experience in the Microbiology space will be an asset in supporting our rapidly growing list of customer engagements as our European footprint expands.”
“Our goal is to efficiently and effectively serve all customers in the broader European market,” said Mr. Tony Bazarko, Chief Commercial Officer for Specific. “The addition of this UK office and increased commercial UK headcount allows us to achieve that goal.”
“France is a very important market for us as we launch in Europe,” said Mr. Bazarko, Chief Commercial Officer for Specific. “There is definitely demand for rapid susceptibility testing and we’ll continue to invest in the French market to meet that demand.”
“With the rise of antibiotic resistance, this study is more important than ever,” said Dr. Paul A. Rhodes, CEO of Specific. “Along with our 6 evaluations currently underway in France, we look forward to the results of this study as we enter the European market.”
Specific Diagnostics announced today that the Department of Defense will award the Company a grant to utilize the Reveal™ AST instrument for rapid assessment of bacteriophage susceptibility of bacterial pathogens.
Specific Diagnostics today announced that it has successfully received its ISO-13485 certification through the International Organization for Standardization. A QMS conforming to ISO-13485 meets the highest FDA standards applicable to businesses operating in the medical device sector.
Specific Diagnostics today announced the appointment of Jeff Holman as Vice President of Global Marketing, as Specific begins its market launch in Europe.
Specific Diagnostics today announced the formation of its primary European subsidiary, Specific Diagnostics Europe Limited, an Irish company that will act as Specific’s primary importer for European, UK and Middle Eastern Sales.
Specific Diagnostics today announced the appointment of Stephen Abel as Head of Commercial Operations, UK, as it rapidly expands its commercial operations in Europe.
Specific Diagnostics today announced CE-IVD registration of the Reveal rapid antimicrobial susceptibility testing system. European availability of Reveal is now beginning in France, led by 6 distinguished evaluation sites.
Specific Diagnostics today announced it has entered into a sponsored agreement with the University of Versailles-Saint-Quentin-En-Yvelines to conduct a year-long study to evaluate the performance of the Reveal Rapid AST System and consumable assays.
Specific Diagnostics today announced the appointment of Anthony Bazarko as Chief Commercial Officer, as it begins its market launch in Europe. Mr. Bazarko is an industry veteran with over 15 years of senior leadership experience, having most recently served as the Vice President of Commercial Development, Americas and General Manager of Canada at Danaher Corporation’s subsidiary Leica Biosystems ($1B in 2019 sales).
Specific Diagnostics today announced that it has successfully completed a 4-day onsite audit confirming the completion and implementation of its ISO-13485-complaint quality management system, the final milestone required for designation as an ISO-13485 certified manufacturer of medical devices.
Specific Diagnostics today announces that Greg Curhan has joined its Advisory Board. “Greg is joining us at a time when we are scaling up, and his acumen in financial systems as well as the capital markets is a timely addition to the perspective of our lead investor Telegraph Hill Partners,” said Dr. Paul A. Rhodes, Specific’s founder and CEO.
Specific Diagnostics today announces that the National Institute for Allergy and Infectious Disease (NIAID) has awarded a second major grant to drive the commercial introduction of Specific’s Reveal system, which provides quantitative determination of antibiotic efficacy within hours of positive blood culture, with minimal sample preparation and at a low cost. The Reveal antibiotic susceptibility testing (AST) system offers phenotypic MIC matching CLSI gold standard results within an average of 5 hours from positive blood sample, while greatly simplifying workflow, at a cost low enough to prompt widespread adoption.
“We are looking forward to demonstrating the clinical performance of the Reveal AST instrument and consumable assays during this year’s ECCMID conference. This is another major step towards commercial deployment,” said Ray Martino, Specific COO.
“CARB-X has a very engaged expert oversight team with whom we worked closely during the first phase of our award. We are honored to be one of just 5 diagnostics companies in the Powered by CARB-X portfolio, and that the CARB-X advisory team has seen fit to recommend a continuation of this invaluable support. We look forward to bringing Reveal to clinical laboratories in both Europe and the United States during 2019,” said Paul A. Rhodes, Ph.D., Specific’s CEO. “The simplicity of our instrument and disposable provides for robust performance, ease of use, and high throughput, at a price low enough to prompt widespread adoption. We could not have gotten here without CARB-X support.”
“I am very gratified that a research and clinical leader of Ellen Jo’s worldwide stature has chosen to contribute her insight to Specific at this time,” said Paul A. Rhodes, Ph.D., Specific’s CEO.
“We are looking forward to introducing the transformative Reveal AST/ID instrument and
consumable assays at ECCMID, and making it available for clinical evaluation in 2018,” said Ray
Martino, Specific COO.”
“I am delighted to welcome Susan to Specific just as we are bringing our rapid AST/ID instrument to the community. We will benefit from her guidance and feedback regarding both this instrument and our product roadmap, as she brings deep insight as to what lab directors need to improve practice, system performance, and above all patient care.,” said Paul A. Rhodes, Ph.D., Specific’s CEO.
“We are honored and inspired to have been selected by CARB-X, which has rapidly emerged as among the
world’s leading funders of solutions for drug resistant infection,” said Paul A. Rhodes, Ph.D., Specific’s CEO.
“Our new instrument determines phenotypic antibiotic susceptibility with hours of blood infection, and CARBX’s support affirms the importance of that capability and helps us bring it to clinics around the globe for
evaluation in 2018.”
“Dr. Patel will bring an extraordinary depth of experience to Specific as it readies its first instrument for clinical
evaluation,” says Paul A. Rhodes, Ph.D., Specific Technologies CEO. “SpeciFAST™ promises to enable highly
accurate phenotypic MIC determination in four hours, directly from a positive blood culture, meeting a vital
need for patients with antibiotic resistant infection. Dr. Patel has been at the forefront in evaluating new
technologies for assessment of blood infection, and her appointment at this time is very welcome.”
Specific Technologies, which has developed a novel paradigm combining the detection and identification (ID) of microorganisms during blood culture, announces today a revolutionary system combining phenotypic AST with ID, performed in 4 hours directly from a positive blood culture sample.
“This announcement continuesto establish SpecID™ asthe only technology to combine detection
with ID during primary blood culture. By extending this paradigm, which we have reported for
bacterial and mycobacterial infection, now to the clinically important case of yeast infection, we
demonstrate a general and novel paradigm for microbiology diagnostics that promises to
streamline the lab, by combining the detection, Gram status and ID of pathogens as they grow in
blood culture,” said Paul A. Rhodes, Ph.D., CEO of Specific.
“We believe that this discovery could have, if validated, substantial and broad clinical impact,” said Dr. Paul Rhodes, Chief Executive Officer of Specific Technologies. “We invite researchers with interests ranging from clinical care of blood infection to the metabolomics of drug resistance mechanisms to visit our poster, interact with our scientists and visit our booth.”
“We are dedicated to revolutionizing the existing blood culture and susceptibility determination paradigms, and the support from organizations like NIAID enables us to expedite the
commercialization of our unique solutions for the global marketplace,” said Rob Lozuk,
President of Specific Technologies.