NEW YORK (360Dx) – British diagnostics company Mologic has completed development of a next-generation lateral flow testing platform that it claims improves sensitivity significantly. The Bedford, UK-based firm is also working with a new center in Dakar, Senegal, that will deploy new tests based on the platform to support early detection of tropical diseases.
Mologic made an announcement regarding its platform development milestone last week. The company said it had developed devices for testing malaria and HIV that could be visually read and attained a sensitivity of 1 picogram per milliliter, a "1,000-fold improvement in sensitivity" over its current technology.
It also said these innovations could be replicated for "any protein or small molecule target with associated performance gains." Mologic now hopes to make its technology available for point-of-care testing in developing countries.
"What we really want to do, is to make point-of-care, pregnancy test-like devices available for infectious disease testing," said Chief Medical Officer Joe Fitchett. The platform was developed with the support of the Bill & Melinda Gates Foundation, which since 2016 has invested nearly $10 million into a collaboration with Mologic called the Center for Advances Rapid Diagnostics (CARD), with the main aim of improving lateral flow technology.
Fitchett in an interview described the resulting CARD platform as "very lightweight, a strip on a card achieving that [level of] performance that we hope will be distributed at healthcare centers for diagnosis and follow up, without being dependent on infrastructure," such as a nearby laboratory. "We are looking to make these tests robust and able to be used in the field," he said.
Fitchett, who is also head of global health at Mologic, joined the company last year from the Gates Foundation, where he advanced the nonprofit's partnerships with EU donors, and also worked on building out capacity for manufacturing yellow fever vaccines and infectious disease tests at the Institut Pasteur of Dakar.
He said that tests deployed on the new platform could aid in combating epidemics in countries such as Senegal by identifying patients who carry and transmit infectious diseases. The company has received a new $4.9 million grant from the Gates Foundation to improve the sensitivity of its approach further and to accelerate product development, Fitchett said. This year, the company will also make the platform available to partners through its services division, he said.
According to Fitchett, Mologic has been able to improve the sensitivity of its platform due to several factors. The company has invested in antibody engineering, he noted, looking at the "full spectrum of vertebrates, including camels and other species less commonly used in the diagnostics space," he said. This has allowed the company to uncover high-performing antibodies to guide antibody engineering.
Another aspect is the use of a novel particle that "isn't gold but performs better than gold" in binding to targets, Fitchett said. He said the firm would discuss the advance in the future. Mologic has also worked to control nonspecific binding in its assays to improve performance. It has also worked in "molecular choreography," the sequence of the various steps that comprise its assays, he said, also to improve the sensitivity of the test platform.
Finally, the company has developed a "smarter design" for the devices that run the tests, driving down costs so that the price of running the tests will be "well under a dollar a day," enabling them to be disseminated in developing countries, according to Fitchett.
He said that as part of a second phase in platform development, Mologic will aim to simplify sample preparation further, and will work on combining protein targets with some other targets while developing a way to transmit data back to a centralized resource for health providers to improve disease surveillance and monitor the performance of various tests.
"In phase 2, we will try to drive sensitivity down further," Fitchett noted. "We don't have a target, but we will try for another thousandfold improvement," he said.
Mologic was founded in 2003 and currently employs around 70 people worldwide. CSO Paul Davis helped pioneered the use of lateral flow technology in home pregnancy testing in the 1980s. Alere, now part of Abbott, acquired Mologic in 2009 but divested the firm in 2014.
Since then, the once-again independent Mologic has worked to build its capabilities in the development of point-of-care assays and devices. This includes expertise in developing and manufacturing lateral flow assays, enzyme linked immunosorbent assays, reagents such as peptides and antibodies, device development, contract manufacturing, and services for partners.
In addition to infectious disease, respiratory disease and women's health are also core markets for the company. Within its infectious disease testing program, Mologic has tests in development focused on sepsis, dengue, peritoneal infections, and periodontal disease, among other diseases.
According to Fitchett, Mologic intends to deploy the CARD platform as part of a new responsive manufacturing and education facility at DiaTropix, an infectious disease testing center being set up at the Institut Pasteur of Dakar. Amadou Sall, scientific director at the institute, said that DiaTropix should become operational by the end of this year.
"We are working on establishing a platform from which we can develop rapid diagnostic tests, that is completely dedicated to epidemic disease and completely dedicated to tropical diseases," Sall said.
Sall said that funding is in place to support the opening of the center but declined to provide a budget for DiaTropix.
"The expertise of Mologic is in doing rapid diagnostic tests, and making it happen in a context like Africa, where this is of the utmost importance," Sall added. "This will help with surveillance and will help drive epidemics down."
Sall said that countries in West Africa need a center like DiaTropix to improve surveillance of epidemic diseases in the region. "If you talk about epidemic diseases, the earlier you detect them, the better you can control them," Sall said. "In surveillance, the weakest link in most countries in Africa is often the laboratory," he added. "If you have rapid detection tests, though, you don't need a laboratory. It's simple to use in a decentralized context."
Currently, reducing the spread of yellow fever and dengue are objectives of the institute and will be a focus of DiaTropix once it becomes operational. "These are common diseases transmitted in a context where if you can control them it can have a humanitarian and economic impact," he noted. "Usually what happens is that by the time we get people tested by a lab, the epidemic has spread," he said. Having a rapid, low-cost platform would help control high-consequence epidemics like ebola or yellow fever, he noted.
Fitchett said that Mologic is working with Institut Pasteur of Dakar to introduce them to the new CARD lateral flow technology and to train staff members with the new aspects of lateral flow device manufacturing. He confirmed the company also would work with the new DiaTropix center on diagnostics for dengue and yellow fever.
"Yellow fever is number one in our priorities," noted Sall. "It's a major killer." He remarked that early detection of yellow fever is also in line with World Health Organization strategies to eliminate the epidemic in Africa and South America by 2026.
In addition to yellow fever and dengue, DiaTropix might introduce other tests for meningitis and measles, Sall further noted.