Impact case study database

Binx io is a small, desktop instrument that processes a single-use, assay-specific cartridge for the detection of sexually transmitted infections (STIs) with no sample preparation necessary. The point of care (POC) instrument developed by Binx Health combines ultra-rapid, polymerase chain reaction (PCR) amplification with sensitive electrochemical detection technology developed by Bath Chemistry. Binx io is fully automated and easy to use. Simply load the cartridge into the device and in about 30 minutes, the io provides easy-to-understand results allowing “test and treat” to become a reality.

Key impacts from this work are investment, people and a new technology

• SME has generated investment raising a total of USD55,000,000 venture capital investment (Series C in 2015 and Series D in 2017) [C];

• Creation of highly skilled jobs (growing to 43 FTE), recruitment of industry leaders, including from an environment for career development (KTP Associate with University of Bath progressed to Chief Technical Officer) [B];

• A new diagnostic technology has been tested and approved for sale (successful clinical trials of the binx io platform in 2019 led to European CE Mark approval and FDA 510(k) clearance in the US to test and treat women for chlamydia and gonorrhoea) [I].

The Chief Technical Officer at Binx Health said: “ In August 2019, we received 510(k) regulatory clearance from the U.S. Food and Drug Administration for our chlamydia and gonorrhoea test (CT/NG). This marks a huge milestone for the company, and one drawn from many years of development from the original research at Bath. The key contribution from the Chemistry collaboration has been the design and synthesis of novel ferrocene labels that can be tagged onto different target oligonucleotide sequences and used in a multiplex assay as in the CT/NG test” [A].

Economic, Wealth and Opportunity Creation

Atlas Genetics was launched in 2005 with GBP500,000 initial funding, 50% of which came from the Sulis Seedcorn Fund, established by the University of Bath to provide support for new businesses. Since 2014, the diagnostic platform incorporating the Bath electrochemical technology has been manufactured, tested and approved for sale. In 2018, the company rebranded to Binx Health in preparation for the global launch of the POC platform, the binx io. Concurrently, the company opened an office in Boston, US to focus on delivering successful clinical trials, sales and marketing in the US. The company also added healthcare leaders in new roles on the management team [B]. The number of full-time staff across both sites increased to 43, the majority of whom have higher education qualifications in science (MSc/PhD), engineering (BEng/MEng) or business (MBA).

Binx Health is currently venture capital funded and to date has raised approximately USD115,000,000. During the REF period this has included completion of Series C (in 2015) and Series D (in 2017) financing, raising USD55,000,000 to specifically fund the clinical trials, device manufacture and commercial launch of a dual test for the electrochemical detection of chlamydia and gonorrhoea [C].

The io cartridge was developed in collaboration with Bespak, a global market leader in the development and manufacture of medical devices. The manufacturing line for the io cartridge has been established within dedicated purpose-build ISO Class 8 cleanroom at the Bespak site in Kings Lynn, UK. This strategic investment in UK manufacturing will facilitate the future scale-up in capacity for Binx products [D].

Clinical Implementation

The electrochemical technology at the core of the binx io tests offer a time-to-result turnaround of less than 30 minutes, which enables the opportunity to test and treat in near-patient settings reducing the spread of infections for millions who require screening under medical guidelines. The pathway to regulatory clearance and European CE Mark approval has involved clinical trials with Public Health England (PHE) and the National Institutes of Health (NIH) in the US [E]. In 2018, a team at Johns Hopkins University tested binx’s rapid POC test for chlamydia at clinics in Maryland and Ohio. The study, consisting of 296 recruited patients, determined the binx test provided an accurate positive result 93% of the time and an accurate negative result 99% of the time for vaginal self-obtained swabs [F]. In 2019, the company completed a 1,523-person, multi-centre clinical study on the binx io in a POC setting. The outstanding results showed a 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhoea in women tested. Binx received its CE Mark for CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) in May 2019 [G] and FDA 510(k) clearance in August 2019 [H, I].

In the first “real world” use, a collaboration with 3 NHS Trusts and St. Georges University of London, the binx io platform is being used by clinicians to diagnose patients who otherwise would have faced up to several days of delay between infection, identification and treatment. Clinical consultant Lewisham and Greenwich NHS Trust said: " So far, we have tested about 90 patients, have had 17 CT and two NG positives and were able to provide the right antibiotic in a single visit. British Association of Sexual Health and HIV quality standards suggest treatment within three weeks of testing. We can now provide the right antibiotic in one visit. This is game-changing for us" [J].