NEW YORK – Headed by a team of diagnostics industry veterans, ReadyGo Diagnostics emerged last week from two years in stealth mode with plans to parlay a novel sample prep method, two isothermal molecular diagnostics systems, and assay development expertise into commercialization partnerships with other companies.
ReadyGo was founded in Bath, UK, at the beginning of the coronavirus pandemic by Ben Cobb, a developer of the GeneDrive isothermal molecular diagnostic system to test for tuberculosis and hepatitis C virus.
In an interview this week, Cobb said founding ReadyGo enabled him to recruit his ideal team of molecular diagnostics experts — including former colleagues and competitors such as Elaine Warburton, former CEO at point-of-care molecular diagnostic system developer QuantuMDx, and Ben Reed, former business and commercial director at Epistem and PrimerDesign.
One of the key innovations for ReadyGo is in the sample collection and preparation step. While developing a tuberculosis assay at GeneDrive, Cobb gleaned that this step was a major hindrance for molecular diagnostics. A simple method enabling collection of standardized samples was needed for point-of-care and over-the-counter use, he said.
The swab-on-a-stick method of sampling was developed in the 1920s, Cobb said, and although it now uses newer materials, the overall approach has not progressed much.
"We wanted to develop a more user-friendly, reliable, robust way of sampling," Cobb said.
The ReadyGo solution to this problem is a one-piece disposable device about the size of a highlighter pen, called Snap, which integrates sample collection and preparation. It contains a dried lysis reagent integrated into a nib of engineered material that wicks up a defined amount of patient sample using capillary action. The lysis reagents are similar to those used in mouthwash, Cobb said, so it is safe for humans but also known to be very effective at busting open pathogens. And, importantly, it does not inhibit nucleic acid amplification reactions, he said.
With the Snap device, a user collects a sample, then bends the device to break an internal valve releasing exactly the amount of buffer required for the reaction into the chamber. A single squeeze of the bulb on the end of the device then releases the contents for diagnostic testing.
This simple sample prep allows the team to lower the cost of the diagnostic assay because it doesn't require any moving parts.
Warburton said Snap eliminates the buffer measuring steps that challenged some lay users of over-the-counter lateral flow COVID-19 tests.
"Lateral flow tests were like a science experiment in the kitchen, and nobody read the instructions — is it two drops, three drops, or four — so there were erratic inconsistencies within the results," she said. "The Snap practically eliminates all of that, because you just squeeze the whole [liquid contents] through."
Snap can be used with saliva, nasal, and buccal samples and to collect samples from surfaces like skin. ReadyGo is also developing blood, urine, and stool sample collection versions.
The device can be paired with a small instrument, called Geo, which is an eight-well isothermal amplification platform. A user directly transfers the contents of the Snap device into tubes pre-filled with assay reagents, then puts the tubes in the Geo instrument for amplification and readout.
"It really eliminates the lab completely — no need for pipetting; it's all done in the disposable," Reed said. "Unlike systems before that use cartridges and pumps or actuators, our choice of materials does away with all that."
The cost of the Geo platform is projected to be less than $1,000, with individual assays in the $10 range, Reed also said. At this price point, the firm is aiming to deliver "low-cost diagnostics to small labs and research groups," he said, noting that the Geo has been designed to go anywhere, "even off-grid."
ReadyGo has also developed an all-in-one system called Snapshot, in which the process is even more streamlined.
Snapshot uses a modified version of the Snap sampler that also has dried test reagents contained in the second half of the disposable. These in turn mix with the buffer and sample, and a single Snap device can be inserted into the Snapshot instrument for amplification, Reed said, with results read out on a mobile phone app.
Both the Geo and Snapshot provide results in about 20 minutes.
For the isothermal amplification on Geo and Snapshot, the team has developed tests using both recombinase polymerase amplification (RPA) and loop-mediated isothermal amplification (LAMP), but also currently has its own proprietary chemistry in development, Cobb said.
Overall, the team has "not tried to reinvent the wheel" with its approach, he said, but is instead packaging decades of molecular diagnostic development in a different way.
Not only do small, modular systems favor decentralized point-of-care and at-home testing, but the firm also aims to decentralize the manufacturing and commercialization steps.
For example, the Geo and Snapshot systems were purpose-built to employ 3D printing in the manufacturing process so that they can theoretically be made locally, close to wherever testing is needed, and take advantage of a lower cost of assembly in different parts of the world. They also have a streamlined design that reduces the amount of plastics required to build them.
"We designed the systems with end of life in mind, considering what happens at the end of the journey when [the products] need to be dismantled and recycled," Cobb said, noting that 3D printing offers a number of advantages there.
ReadyGo also plans to partner with other labs and companies and develop tests that the partners can commercialize.
"Our strategy is to not actually go to the professional-use market ourselves," Cobb explained, but rather to partner with companies that are looking to enter those markets that don't necessarily have a platform or any expertise developing assays. "We see ourselves as providing a turnkey solution," he said.
For example, last week ReadyGo said that it is working with Canada-based lateral flow assay developer Gemina to help them provide a molecular offering. ReadyGo has developed a saliva-based LAMP tuberculosis assay for the Geo system that Gemina will now commercialize, with Gemina manufacturing the assays and ReadyGo supplying the equipment.
In this business model, the assays in development will depend on the partner's needs, but to Cobb, tuberculosis is a particularly great test case for a portable MDx system. The prevalence of the disease in remote and resource-poor settings requires that test devices not only be small, low cost, and rapid but also have high levels of sensitivity and specificity.
And, "we've all got experience in developing tests for TB, and we understand the difficulties and issues in taking a test to that market," he said, adding that the three core team members have worked with most countries and nongovernmental agencies in this area.
The TB space exemplifies issues spread across all the diagnostics markets, Cobb said, so, "if you can create a solution for that market, I think you can pretty much create a solution for anything; so that is why it is a passion of ours."
A niche in the competitive landscape?
The point-of-care molecular diagnostic market was christened with the debut of the Abbott IDNow (formerly known as the Alere i) and the Roche Liat in the mid-2010s. These systems paired small diagnostic devices with assays for illnesses that had high rates of transmission, like influenza, strep A, and respiratory syncytial virus.
While these large companies have pursued a handful of "killer apps" for their diagnostic menu, Cobb said, ReadyGo believes that there is a large unmet need for the many forgotten diseases that have lower incidence rates.
Tests for these diseases could transform healthcare around the world, but the return on investment is perhaps harder for a large company to justify.
In addition, Warburton noted that there is an increasing demand from consumers to be able to test themselves at home.
The key to both the resource-limited and at-home markets is the same — cost — and Cobb said that the firm is aiming to make its test prices on par with the cost of lateral flow assays.
"With the current pressures and the health system at a breaking point … consumers will increasingly demand over-the-counter tests," Warburton said. "We believe we are set up to be able to deliver a low-cost, highly accurate test that consumers can rely on."
The firm is also seeking partners to integrate Snap into lateral flow immunoassay development, noting that it could also be paired with PCR or whole-genome sequencing approaches. And, the sampling device can be designed to incorporate other chemistries, such as physiological markers of disease, that could enable it to be used in biochemistry testing.
ReadyGo is also offering a development service, called Flex, which allows customers to transfer their assays and provides dried reagents within the engineered material.
Besides infectious disease testing in healthcare and at home, the team envisions that Geo and Snapshot could be deployed for near-patient genetic and susceptibility testing as well as for agricultural, veterinary, and forensic testing.
"The patient's journey starts with diagnostics," Warburton said. "If you can produce an elegantly simple, fiercely simple device that consumers and professionals can use, at a price that is affordable, and a performance level that is commensurate with molecular testing, then it can have mass uptake across the entire world."