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MIP Diagnostics Developing SARS-CoV-2, Troponin Molecularly Imprinted Polymers

NEW YORK ─ MIP Diagnostics is accelerating internal product development of molecularly imprinted polymer (MIP) technology that it believes has advantages over traditional antibodies for diagnostic testing.

The company's MIPs are prepared using a proprietary imprinting process involving the self-assembly of binding monomers around a target to create a novel affinity reagent. The monomers are polymerized to generate a synthetic antibody that targets a binding site on an antigen associated with a medical condition.

The Sharnbrook UK-based company has been using MIP technology, which it acquired from the University of Leicester in 2015, to engage in contract development work and develop products for other companies. It intends to continue its contract development work, but "going forward, we have an ambitious plan to develop an in-house portfolio of products, starting with the development of MIPs for biomarkers we believe are most needed in diagnostics," the firm's CEO Stephane Argivier said in an interview.

The company is accelerating product development on the back of £5.1 million ($6.5 million) in financing this month. In April, it began collaborating with Macclesfield, UK-based Stream Bio to develop SARS-CoV-2 antigen reagents for a point-of-care rapid diagnostic test and high-throughput screening test. The assays are being designed to target and latch on to virus spike proteins, the firm said.

Because MIP technology allows for the rapid design of new assays, the company designed a prototype nanoMIP for its SARS-CoV-2 assay in about four weeks, Argivier said.

MIP Diagnostics anticipates completing and validating the SARS-CoV-2 nanoMIP, he said, before this winter and in time for an anticipated "second wave" of the novel coronavirus, and the company has started the development of a troponin I nanoMIP suitable for cardiovascular disease assays.

To achieve adoption of its technology, however, MIP Diagnostics will need to convince customers that its MIPs have advantages over traditional antibodies, and competing with antibody-based reagents and assays, a mainstay of in vitro diagnostic testing, is an uphill battle. Antibodies are well understood, and companies have been investing in them for decades, so there have to be compelling reasons to switch to alternative reagents.

Still, Argivier noted, companies collaborating with MIP Diagnostics on a contract basis usually decide to engage with it because of performance limitations associated with antibodies.

Marloes Peeters, a professor at UK-based Newcastle University who has published research on molecularly imprinted polymer technology, noted that antibodies' limitations include high batch-to-variation and limited stability. Though antibodies can be produced using recombinant technology, many developers "use animals, and it is estimated that in the UK alone each year, several thousand animals are sacrificed to obtain antibodies used in diagnostic assays," said Peeters who is not affiliated with MIP Diagnostics.

She noted that molecular imprinting has evolved "as an interesting alternative over the years" because polymers are cost effective, involve an animal-free production process, and have stability in extreme environments, including broad temperature and pH conditions.

However, the use of MIPs in commercial applications has been limited "because most of them have not shown that they are able to compete as yet with antibodies on specificity and sensitivity," she said. "On the other hand, MIP Diagnostics' technology enables the production of high-affinity nanoparticles that match the sensitivity of antibodies and in some cases outperform them. Due to their inherent biocompatibility and versatility ─ meaning the particles can be adapted to whatever target is of interest ─ I expect a bright future for [its] technology in the coming years."

Argivier said that MIPs' robustness and stability lend themselves to the development of diagnostic tests that can be used where refrigeration ─ required by most current reagents ─ is unavailable. Low-resource settings, for example, are not near enough to labs to allow standard lab-based testing. "It's an unmet need that a lot of our customers are trying to address," he added.

Over the years, its researchers have participated in a number of studies published in peer-reviewed publications, including a 2016 paper published in Scientific Reports in which the MIP technology demonstrated performance comparable to or better than that of commercially produced antibodies in enzyme-linked competitive assays.

In the paper, researchers at the University of Leicester described molecularly imprinted polymer nanoparticles prepared in aqueous media by solid-phase synthesis with immobilized L-thyroxine, glucosamine, fumonisin B2, or biotin as a template. "The ease of preparation, high affinity of solid-phase synthesized imprinted nanoparticles, and the lack of requirement for cold chain logistics make them an attractive alternative to traditional antibodies for use in immunoassays," they wrote.

MIP Diagnostics uses molecular modeling software to select suitable monomers for its small molecule-based reagents. "There are about 5,000 different monomers identified in the literature, and using the software, we select between three and five monomers at a time that contributes the best affinity characteristics for a given application," Argivier said.

With new funding in hand, MIP Diagnostics plans to triple its workforce to around 36 people within three years. In April, the company announced its collaboration with Stream Bio to develop a SARS-CoV-2 antigen reagent for both rapid-diagnostic and high-throughput screening tests.

Stream Bio’s conjugated polymer nanoparticles, which offer temperature stability, intense fluorescence, and magnetism, are being combined with MIP Diagnostics' stable molecular imprinted polymers. The properties of both firm's technologies "allow for fast development of an extremely sensitive, and stable detection platform for the virus," MIP Diagnostics said.

Its rapid diagnostic test is being designed to detect SARS-CoV-2 in about 10 minutes, while the high-throughput assay would enable detection of the novel coronavirus in labs alongside PCR platforms to increase testing capacity, the firm said.

MIP Diagnostics envisions that a point-of-care test, based on a lateral flow format, could be used for on-the-spot screening. 

In March, the company announced it had entered into an agreement to develop, license, and supply its molecularly imprinted polymers for use with Charleston, South Carolina-based Veravas' sample preparation technology. The agreement aims at developing products that help diagnostic companies manage risks associated with interferences, such as those caused by biotin, in immunoassay testing.

Seeing the potential of synthetic reagents, organizations other than MIP Diagnostics have also been developing products as alternatives to antibodies. Wetherby, UK-based Avacta, for example, has said that a growing number of diagnostic companies are exploring the use of its high-affinity Affimer synthetic reagents. Avacta, like MIP Diagnostics, does contract manufacturing and is developing its own products including an antigen test for SARS-CoV-2.

Meanwhile, Cary, North Carolina-based Atom Bioworks is developing a SARS-CoV-2 antigen test using synthesized DNA antibodies, also as an alternative to traditional antibodies.