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PRESS RELEASES

Major Developments and Exciting News to Share

2021

December 6

Specific Diagnostics Announces the Formation of its US Commercial Team and Introduction of the Reveal Rapid AST System to the US Market

“Our successful European launch, with 11 validation studies across France and England that have been completed or are now finishing, gives us confidence that we are very much ready for FDA clinical studies, as we move to introduce Reveal in the US,” said Jeff Holman, VP of Global Marketing for Specific.  “With clinical trials underway, we want to be informing microbiology leaders who might wish to be early evaluators of our technology in the US.”

December 1

Former Genmark Senior Vice President Scott O’Brien Joins Specific Diagnostics as Chief Commercial Officer

“I can’t think of anyone that understands the critical market demand and is better suited to lead our commercial organization during this dynamic time in our company, than Scott” said Mr. Johnny Ek, Specific’s CFO.

November 5

Specific Diagnostics Announces that David Barreca, former GenMark Sales Leader, Joins Specific as Vice President of US Sales

“I truly look forward to driving awareness and placements in the US with David and his team,” said Jeff Holman, VP of Global Marketing. “The US market is primed for an affordable & rapid AST solution. David’s relationships and experience make him a great partner and he will be a vital part of our success in the US.”

October 7

Specific Diagnostics Commences US Clinical Trials for FDA 510(k) Clearance of its Reveal Rapid AST System

“With preclinical data from over 1,400 clinical samples showing accurate, consistent, rapid, and reliable results,” said Dr. Paul Rhodes, CEO of Specific, “we believe our system is well-prepared for its US clinical trials, and we look forward to introducing this system to key opinion leaders across the US clinical microbiology community.”

October 5

Scott Mendel, former GenMark CEO, Joins Specific Diagnostics’ Board of Advisors

“I am glad to welcome my former GenMark colleague and CEO to Specific at this critical time in our commercial launch,” noted Johnny Ek, Specific CFO and former GenMark CFO.  “Scott’s expertise in rapid diagnostics along with his operational business acumen are perfectly suited to help Specific capitalize on the opportunity we have to bring a winning rapid AST system to this critical unmet need in the market.”

October 4

Specific Diagnostics Announces the First Purchase Orders in Europe

“We find almost universal interest in rapid AST for blood infection, and a great deal for high-urgency isolates as well, across all the distinguished labs we visit in Europe.  The need is widely recognized.  Now that we have demonstrated accuracy, robustness, ease-of-use, and with the comparatively low price and high throughput we offer, these look to be the first of many conversions to clinical use.  Our whole team has worked years to get to this point, and is very gratified that the Reveal system will now be available to help hospital teams better-treat patients suffering from the most deadly and fast moving infections.” Said Dr. Paul Rhodes, CEO of Specific.  

September 3

Specific Diagnostics Gearing Up for Commercial Launch of Rapid AST System

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.”

August 18

Johnny Ek, former GenMark CFO, Joins Specific Diagnostics as Chief Financial Officer

“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.”

August 5

Specific Diagnostics Announces the Results of Two Studies at Hospitals Within AP-HP (Assistance Publique-Hôpitaux de Paris) Evaluating Performance of the Reveal Rapid AST System

“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.”

July 7

Specific Diagnostics Announces that Romney Humphries has Joined its Scientific Advisory Board

“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. 

June 29

bioMérieux and Specific Diagnostics announce a co-exclusive distribution agreement for the SPECIFIC REVEAL® Rapid AST system in Europe

“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.”

June 15

Specific Diagnostics to Attend Canaccord Genuity’s 41st Annual Growth Conference

“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.”

May 25

Specific Diagnostics Announces US Clinical Trials for its Reveal Rapid Antibiotic Susceptibility Testing (AST) System

“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.

April 28

Specific Diagnostics Awarded Grant by the Department of Defense (DoD) to use Reveal for the Rapid Determination of the Antimicrobial Effectiveness of Bacteriophage

“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.

April 14

Specific Diagnostics Announces the Appointment of Scott Wehage as Director of US Clinical Trials

“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.”

March 30

Specific Diagnostics Announces the Appointment of Erwan Seznec as Head of Commercial Operations, France

“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.”

March 10

Specific Diagnostics Announces the Formation of Specific Diagnostics UK Limited and Introduction of the Reveal Rapid AST System for the UK Market

“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.”

February 24

Specific Diagnostics Announces the Formation of a French subsidiary, Specific France SAS

“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.”

February 10

Specific Diagnostics Announces Evaluation Agreement with the French National Reference Centre for Carbapenem-Resistant Enterobacterales (INSERM UMR1184 RESIST unit)

“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.”

2020

December 21

Specific Diagnostics Awarded Grant by the Department of Defense (DOD) to use the Reveal for the Rapid Determination of the Effectiveness of Novel Bacteriophage Therapy

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.

December 2

Specific Diagnostics Announces Designation as an ISO-13485-Compliant Medical Device Manufacturer

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.  

November 18

Specific Diagnostics Announces the Appointment of Jeff Holman as VP of Global Marketing

Specific Diagnostics today announced the appointment of Jeff Holman as Vice President of Global Marketing, as Specific begins its market launch in Europe.

November 11

Specific Diagnostics Announces the Formation of Primary European Subsidiary Specific Diagnostics Europe Limited

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.

November 10

Specific Diagnostics Announces the Appointment of Stephen Abel as Head of Commercial Operations, UK

Specific Diagnostics today announced the appointment of Stephen Abel as Head of Commercial Operations, UK, as it rapidly expands its commercial operations in Europe.

October 15

Specific Diagnostics Announces CE-IVD Registration of the Reveal Rapid AST System

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.

October 13

Specific Diagnostics Announces Sponsored Research Agreement with the University of Versailles-St Quentin in Paris, France

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.

September 24

Anthony Bazarko Joins Specific Diagnostics as Chief Commercial Officer

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).

September 10

Specific Diagnostics Announces Successful Completion of Audit for Certification as an ISO-13485-Compliant Medical Device Manufacturer

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.

July 2

Specific Diagnostics Announces that Greg Curhan has Joined its Advisory Board

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.

June 2

Specific Diagnostics Announces that NIAID has Awarded a Further $2.9 Million for the Commercial Development of the Reveal Rapid Antibiotic Susceptibility Testing (AST) System

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.

2019

March 29

Specific Diagnostics begins clinical demonstrations and testing of the Reveal AST system

“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.

March 28

Specific Diagnostics Achieves CARB-X Milestone and Advances its Reveal Rapid Antibiotic Susceptibility Test For Life-Threatening Drug-Resistant Infections Towards Clinical Testing

“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.”

2018

June 7

Specific Diagnostics Announces that Dr. Ellen Jo Baron has Joined its Scientific Advisory Board

“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.

April 20

Specific Diagnostics unveils the Reveal AST/ID system at the ECCMID Conference

“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.”

April 19

Specific Diagnostics Announces that Professor Susan Sharp, Immediate Past President of the American Society for Microbiology, has Joined its Scientific Advisory Board

“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.

April 3

Carb-X Funds Specific Diagnostics to Support the Development of a Rapid, Accurate Test to Diagnose Life-Threatening Drug-Resistant Infections in the Blood

“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.”

January 5

Specific Technologies Appoints Robin Patel, M.D.,Mayo Clinic, to Scientific Advisory Board

“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.”

2017

June 3

Specific announces unprecedented ability to determine MIC and ID within 4 hours of positive blood culture, using a low-cost disposable.

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.

March 15

Specific Technologies announces the combined faster detection and ID of yeast infection in blood culture

“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.

March 2

Specific Technologies announces discovery of a CRE signature in E. coli. growing in culture, to be presented at ECCMID global summit in April

“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.”

February 28

Specific Technologies has been recognized as a National Institute of Allergy and Infectious Diseases (NIAID) Success Story, joining previous distinguished recipients including Illumina.

“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.

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