License for new precision test for antibodies protecting against coronavirus

08. 09. 2021

The Institute of Biotechnology (IBT) and the Institute of Organic Chemistry and Biochemistry (IOCB Prague), both part of the Czech Academy of Sciences, have signed a licensing agreement with the company Immunotech, a subsidiary of Beckman Coulter, for the manufacture and distribution of a newly developed coronavirus antibody IVD test. The new type of test can quickly determine levels of protective coronavirus antibodies and is thus different from most other tests, which only provide information on the level of total binding antibodies. It will make virus neutralization antibody testing, which is time consuming and costly, far simpler and more affordable. The new type of test should soon appear on the international market.

There is often talk of antibodies in connection with vaccination against the virus SARS-CoV-2 and the risk of illness for unvaccinated and vaccinated people in general. Questions such as how long a person is protected following illness, when is vaccination appropriate, how long is vaccination effective, and when is it advisable to get a booster shot have become not only scientific topics but, in many countries, also decisive political ones.

Ideally, the answers would come from knowing the level of protective, virus-neutralizing antibodies in the patient’s blood. Existing diagnostic tests can determine only the total levels of antibodies produced after contact with the coronavirus, but they cannot say if the antibodies really provide reliable protection.

Not all antibodies are neutralizing

Now, a fundamental change is being brought about by a new diagnostic test developed in a joint project between the laboratory of Cyril Bařinka of IBT and the teams of Jan Weber and Pavel Šácha of IOCB Prague with external collaboration from Jan Plicka.

“The main problem up till now has been that not all the antibodies in the patient’s blood following contact with the coronavirus or its spike protein are capable of directly neutralizing the virus and thus stopping infection of cells in the body. Existing tests can only measure the overall signal of all antibodies recognizing the spike protein, including those that can’t neutralize the virus. In other words, we don’t know what conclusions to draw from the measured values unless we supplement the measuring of antibodies with additional complicated testing,” says Cyril Bařinka, head of the Laboratory of Structural Biology at IBT.

Researchers studied antibodies binding to the spike protein of SARS-CoV-2, which is what the current vaccines also target. They prepared several different mouse monoclonal antibodies that were produced following contact with the spike protein and were capable of binding to it, and they conducted a virus neutralization test to verify the ability of these antibodies to neutralize the viral particles.

“We discovered that only one of the antibodies had any real protective effect, and it successfully neutralized not only the original SARS-CoV-2 but also other known coronavirus variants such as alpha, beta, gamma, and delta,” explains Jan Weber, head of the virology group at IOCB Prague.

Virus-neutralizing antibodies

The researchers then succeeded in preparing a diagnostic test that can measure levels of virus-neutralizing antibodies while ignoring others for which the mechanism and efficacy cannot be determined. This represents big savings of time and money.

Until now, if scientists or doctors wanted to measure antibodies in blood and also determine how effective they really are at protecting against the coronavirus, they have had to not only measure the total amount of antibodies for each individual patient but also verify how effective they were against contagious viruses. That type of testing typically takes several days, is costly, and requires a biosafety level 3 lab, which makes it unsuitable for mass use.

“The developed test is capable of determining the level of antibodies with proven protective properties and thus provide an estimate of the degree of protection against the coronavirus within a few short hours. Compared with a virus neutralization assay, the procedure is very easy and safe and can be carried out by practically any laboratory,” says Pavel Šácha.

Licensing agreement

The company Immunotech, a Prague-based subsidiary of Beckman Coulter that specializes in developing laboratory diagnostics, has expressed interest in the new type of test. The company has signed a licensing agreement with IOCB Prague and IBT, based on which it can now commence industrial manufacturing of a test kit and, in the near future, market it.

On behalf of IOCB Prague, project coordination, management, and licensing negotiations were overseen by its subsidiary IOCB Tech; for IBT, coordination was provided by its Technology Transfer Department and the company i&i Prague.

“The new antibody test and its anticipated market launch represents not only a great success for Czech science but also for the offices professionally engaged in the translation of research results into practice, from initial patent protection and preparation of the project to identification of an industrial partner and finalization of the licensing terms,” says Martin Fusek, director of IOCB Tech.

Source: IOCB Press Release