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British Startup Biofidelity Eyes Targeted Therapy Space With Novel Reagents

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NEW YORK – Cambridge, UK-based startup Biofidelity is developing a pipeline of molecular blood-based assays to help physicians rapidly determine the best treatments for cancer patients and to monitor their progression. 

The team anticipates launching its first clinical diagnostic assay, which will detect targeted, low-frequency genetic mutations in lung cancer, in 2021.

Cofounded in early 2019 by CEO Barnaby Balmforth and Cameron Frayling as a spinoff of British biotech firm Base4 Innovation, Biofidelity has since raised about £1.3 million ($1.7 million) through a seed funding round that included investment from Agilent Technologies and an Innovate UK grant last fall. 

"We were interested in [Biofidelity's] ability to do single-tube multiplexing, and their sensitivity that they were claiming… was attractive," Tad Weems, managing director of early-stage partnerships at Agilent, explained. "[After] an initial investment to help them come out, we then introduced them to our genomics and companion diagnostics division, who saw [the technology] as a potential answer for the clinic due to its simplified workflow." 

Balmforth explained that his team developed a proprietary assay at Base4 that uses four sets of reagents to identify a targeted DNA sequence while removing background DNA in a liquid sample. He believes that the multiplex panel, which runs on standard qPCR instruments and uses liquid handling, can address clinically actionable mutations that are used to guide therapy and monitor cancer patients.

Following DNA extraction from the sample, the assay's workflow involves a total of four reagent additions and incubation, and amplification step, and data analysis.  

Balmforth noted that the overall process can be completed from sample to result in less than three hours. 

"You're essentially [performing] a fluorescent readout [and thus] you have a standard data-analysis step, which is compatible with how it's performed in clinical labs," Balmforth said. "Implementation of this assay is straightforward and compatible with existing instrumentation … as every clinical diagnostic lab will have the tools needed to run the assay." 

Biofidelity researchers tested the assay on several sample types — including tissue and plasma samples provided by Agilent — to demonstrate the technology's potential use on liquid samples. Balmforth noted that the study prioritized performance assessment across the sample types, and "so different numbers of samples were used for different types" from both "patients … and industry standard reference materials."

The researchers examined multiple lung cancer mutations between the different sample types, including errors in EGFR and ERBB2 genes. Balmforth emphasized that the group wanted to assess the tool's limit of detection, specificity, and variation between sample types, rather than demonstrating detection at a specific stage of cancer. 

Repeating the assay across more than 750 runs, the researchers found that the tool had 100 percent specificity and could detect "as little as a single copy of mutated DNA" in a plasma sample, Balmforth noted. 

While noting that Base4 directly transferred patents related to the technology to Biofidelity when the firm was spun out last winter, Balformforth said that the patents have yet to be published. 

Biofidelity has also explored using the technology to detect biomarkers associated with other tumor types, such as KRAS mutations for colorectal cancer. Balmforth envisions applying the technology to help guide targeted therapy and cancer patient monitoring.

"Monitoring requires routine testing, and if you want to monitor a patient over time, you need something this simple, with a fast turnaround time," Balmforth said.  

While unable to comment on specific commercial plans, Balmforth highlighted that the study's results has provided the validation that the firm required to now develop a clinical diagnostic assay based on the reagents. 

"We're developing a pipeline of panels, targeted at different cancers, and are bringing those to market as soon as possible," Balmforth said. He expects to launch the first test for targeted therapy for lung cancer patients in 2021. 

Weems noted that Agilent will mostly have a hands-off approach in terms of supporting Biofidelity's technology development, allowing Balmforth and his team to grow on its own and focus on diseases that they believe "have the most market pull."

Balmforth believes that the technology will allow decentralization of precision cancer drug-response testing, as well as "enable networks of hospital and independent CLIA labs to adopt high-precision genetic testing in a way that fits with their existing workflow and sits on their existing instrumentation." 

"That way, they don't need to invest in new instruments, and instead adopt our assay and offer them to clinicians on a decentralized basis," he added.