Scope Fluidics launches Early Access Program of BacterOMIC system at second center

Scope Fluidics S.A. (WSE: SCP) – a Venture Studio biotechnology company included in the sWIG80 index, which in 2022 closed the largest deal in the history of the Polish life science market, announced the launch of the Early Access Program (EAP) of the BacterOMIC system at its second center.

  • The Company’s intention is that several centers, including those outside Poland, will participate in the EAP.
  • The EAP is scheduled to conclude in early 2025.
  • The Company has completed validation of its internal production line and secured pilot production capacity for cartridges addressing the needs of the EAP.
  • BacterOMIC is the flagship medtech system being developed by Scope Fluidics. The breakthrough technology is dedicated to fighting antibiotic resistance in bacteria – one of the fastest growing medical threats globally.

Gajane Zurawska, Global Business Development Director of Scope Fluidics said: As planned, we are scaling up the Early Access Program of the BacterOMIC system. In short order, we launched the program in two centers. We plan to further expand the list, including overseas locations. We expect to be ready to summarize the results of the program in early 2025.

Scope Fluidics is working to meet BacterOMIC’s operational goals, announced in May 2023. At that time, the company announced: 1) Commencement of testing of the BacterOMIC system under the Early Access Program; 2) Commencement of commercial production of the BacterOMIC system; 3) Expansion of the product and patent portfolio.

The Company announced the timely start of testing of the BacterOMIC system under the Early Access Program in December 2023.

In November 2023. The Company began preparations for commercial production of the BacterOMIC system by signing a cooperation agreement with German company BIT Analytical Instruments, based on which BIT is to produce 10 BacterOMIC devices. The devices will be available for the start of commercial production and for the expansion of the Early Access Program.

At the turn of the year, Scope Fluidics announced that its subsidiary Bacteromic sp. z o.o. was granted two patents in the United States. The first related to a method and system for ultra-fast drug resistance determinations of microorganisms, and the second to measurement cards (microfluidic chips used in cartridges).

The BacterOMIC system is a response to the growing global medical threat of antibiotic-resistant bacteria. The World Health Organization estimates that by 2050, the annual number of deaths from infections caused by drug-resistant microorganisms will rise from 700,000 to 10 million per year, making them one of the leading causes of death worldwide.

BacterOMIC’s technology is expected to make patient treatment faster and more effective by pinpointing the best targeted therapies for a given patient. In up to 16 hours, it will accurately assess the susceptibility of bacteria to all clinically important antibiotics and provide the physician with comprehensive information on the pathogen in question. The test’s market-leading informativeness is a key among several competitive advantages of the system.

BacterOMIC has been CE-IVD European certified for marketing in the European Union since 2021. Development of the system began in 2016, and a special purpose vehicle, Bacteromic sp. z o.o., was established in 2017. In 2019, the BacterOMIC project became a semi-finalist in the prestigious American Association for Clinical Chemistry Disruptive Technology Award Competition.