NEW YORK (360Dx) – Mologic is expanding into the US market and targeting the near-term commercialization of rapid respiratory diagnostics for use in the home.
Simultaneously, the Bedford, UK-based company is developing rapid sepsis diagnostics for use in primary care and emergency room settings.
The firm is taking its in-home monitoring systems for chronic obstructive pulmonary disease (COPD) and cystic fibrosis and professional-use sepsis confirmation system through clinical trials, and it anticipates launching them in the next couple of years in the US and Europe.
The tests use multimarker lateral flow technology coupled with readers and cloud-based analysis algorithms as a basis for systems that provide warnings of emergent medical conditions.
"Our foray into the US market is somewhat overdue," said Mark Davis, who founded the company in 2003 with his father Paul, in an interview, adding "The US is a markedly different product market space and clinical community from the UK and Europe," with different reimbursement and regulatory environments among other market characteristics.
Mologic's diagnostic test pipeline spreads across multiple markets and disease states, but it is based on a specific core competency — measuring enzyme and protein marker activity in a rapid point-of-care, lateral flow format for determining a host immune response.
The pipeline includes women’s health assays that detect bacterial vaginosis and urinary tract infections, and infectious disease diagnostic tests for dialysis, dengue, and malaria.
The firm received CE marking for a home-use peritoneal dialysis infection diagnostic in February 2017 and a bacterial vaginosis diagnostic test for professional use — in primary care settings or hospital labs — in March 2017.
"For respiratory conditions, we're using urine-based diagnostic markers to monitor lung inflammation events that are indicative of an emergent exacerbation," Davis said. "This is a radical departure from the role of a simple lateral flow diagnostic that provides positive or negative results."
The diagnostic system, consisting of disposable test strips, an electronic reader, and an algorithm for data analysis, is part of a company strategy to enable targeted patient management and to keep chronic disease patients out of the hospital and in the home, reducing healthcare costs without reducing the quality of care, he said. With the early warning systems for COPD and cystic fibrosis, patients would be able to detect early manifestations of advancing conditions, he noted.Â
The firm's core technology for diagnostics is lateral flow. However, instead of using a single biomarker, which is employed in most lateral flow testing, the technology consists of multiple biomarkers on a single test strip. All of the company's assays detect protein and enzyme biomarkers, which Mologic declined to disclose for competitive reasons.
For at-home testing of COPD and cystic fibrosis, "the biomarkers are known and accepted within the clinical community and are well understood in their connection with the clinical condition, but an algorithm incorporates changes in each one of the marker concentrations and brings about a marked improvement in the ability to diagnose and manage the emergent exacerbation," Davis said.
The North American market
In anticipation of its expansion across the Atlantic, Mologic recently hired Steve Fletcher, formerly of 3M and Thermo Fisher Scientific, as its president of North America operations and to lead its expansion into the region.
Based on its growth objectives for the US business, the firm anticipates adding between 10 and 15 specialists, including scientists, analysts, and people who work in sales and marketing. It currently employs 65 people, including 45 scientists, almost all based in the UK.
The firm is doing clinical verification and validation of the COPD and cystic fibrosis diagnostic systems through an observational trial that it has just completed and a randomized controlled trial that will start in early 2019. It received £2 million ($2.6 million) in funding from Innovate UK to support the COPD portion of the trail as part of a two-year program. All patients in both trials are currently located in the UK, but Mologic is looking to expand to include patients in North America.
Performance data from the observational trial, using neural network analysis, provided an R square value — a statistical measurement used to predict future outcomes or to test hypotheses  — of 0.89 with an 85 percent sensitivity and 86 percent specificity, Mologic said. Davis said that the firm is continuing to push the limits of detection below 1pg/ml for lateral flow testing.
"We are forecasting a product introduction in 2020 assuming a positive interaction with the US Food and Drug Administration, which has yet to begin," Davis said. The firm, he said, is interested in publishing the results of its observational clinical trial by early next year.
The randomized controlled trial for COPD included about 300 patients, and the cystic fibrosis trial slightly less, he said.
Meantime, the sepsis confirmatory diagnostic system is a multi-biomarker lateral flow assay that uses an algorithm to detect emergent sepsis and differentiate it from systemic inflammatory response syndrome, or SIRS, but the company is developing the system for professional use in emergency departments or acute care settings rather than the home.
Mologic has secured £1.3 million in funding from Innovate UK to support a clinical trial for the sepsis confirmatory system and is working with "notable" medical centers and hospitals in the UK to implement the trial. The collaborating teams have begun selecting samples. Clinicians are using the system to test clinical samples and the results are being sent to Mologic for evaluation and to determine whether the sample indicates sepsis or SIRS in patients.
Mologic anticipates that the sepsis diagnostic product could be available toward the end of 2019 or by mid-2020, depending on its progress with clinical trials, and it intends to launch the diagnostic system in North America and Europe.
Tim Sweeney, CEO of Inflammatix, which is developing a molecular multiplex platform to aid in sepsis diagnosis, said in an interview that the Mologic approach is "great confirmation from the market that the single-biomarker approach to sepsis is fading quickly [and] that host response is an area that’s likely to fill a key physician need in sepsis."
A key point, he said, is that no single marker is able to do both diagnosis and prognosis well. The claimed multi-marker approach, he said, which requires an algorithm to interpret the markers and produce a clinically actionable score, must be rigorously validated.
It is extraordinarily difficult in sepsis to deliver a fixed, calibrated algorithm that delivers clinically meaningful results, Sweeney said. The real proof, he said, is in application of a fixed algorithm in independent data.
Lateral flow legacy
Mologic has always used lateral flow technology as a component of its diagnostic products. In 1984, Paul Davis was part of the lateral flow diagnostic development team that patented technology which led to the launch of UniPath as part of Unilever. The technology and its patents became the basis of the Clearblue brand for home pregnancy testing launched a year later.
In October 2009, Alere, now part of Abbott, acquired Mologic for an undisclosed fee and  integrated the firm as a dedicated R&D unit with a broad scope and a focus on rapid diagnostics for respiratory disease over a long-term horizon, Mark Davis said.
In 2014, after an Alere leadership and strategy change, it divested Mologic for an undisclosed amount. The firm became independent through an investor buy-in and management buyback. The technology, personnel, facilities, capability, intellectual property, and product pipeline stayed with Mologic, Mark Davis noted.
"At that time, Alere decided to focus on certain areas of its portfolio and release others," he said. "It was fairly obvious that the research areas we were engaged in were a few years away from realization, and as a consequence would have required further funding. We were a cost center for the business at a time when it sought to remove cost centers."
Project funding
In 2016 the Bill and Melinda Gates Foundation sought out Mologic as its partner to engage in the development of a new high-sensitivity technology platform for rapid diagnostic applications. The collaboration called CARD, the Centre of Advanced Rapid Diagnostics, recently delivered on its first milestone objective of a platform that can measure protein antigenic targets down to 1pg/ml without the need for a reader or other technology, the firm said. This firm anticipates that the technology will be made available to clients during 2019, along with a tailored development service.
Mologic has raised £7 million since 2015 from enterprise investment scheme and venture capital trust investors in the UK.
In April, the firm announced that it had inked an agreement with PATH, an international nonprofit with a focus on improving health, to advance a new rapid diagnostic test to support treating and eliminating Plasmodium vivax malaria.
In May, the firm inked European distribution agreements for its Periplex point-of-care test for detection of infections in patients undergoing peritoneal dialysis.
Also in May, Mologic received a £4 million Series B investment that came from funds managed by Foresight Group with existing investor Calculus Capital.
Fraunhofer UK Research is working with the firm to develop a new microfluidics-based test to not only identify if bacteria causing urinary tract infections are present, but to gauge their resistance to different antibiotic treatments. NHS England recently awarded the project roughly £900,000 following an initial investment of £92,000 in April 2017.
In his efforts to introduce Mologic's products in North America, Fletcher is focused on understanding the difference in the dynamics of the North America market versus those of Europe and particularly the UK. "The whole idea is to obtain a better understanding of the reimbursement and regulatory landscapes and ultimately the uptake of the products, their value proposition, and their positioning," he said in an interview.
Pricing or products has yet to be determined, Mark Davis said, but given that its systems use lateral flow technology and inexpensive readers, they will be favorably priced compared with other emerging technologies such as molecular diagnostics, he said.
Mologic is currently seeking US-based clinical and key opinion leader partners, he added.