Genekam Biotechnology AG has developed one of first world´s magnetic beads ELISA test
as point of care assay for coronaviruses, which is 1000 times more sensitive and can be
finished within 50 minutes against the routine ELISA method, which takes hours to be
performed and give the results with low sensitivity.

Moreover, it can be performed anywhere in the world against the conventional ELISA and
PCR tests, which need special instruments, hence they can be performed only in special
laboratories. Cost of Genekam test is Euro 1 against PCR test, where the costs are Euro 8.
Magnetic beads are being used in medicine to perform a number of tasks e.g. isolation of
RNA and cell separation for development of immunotherapies. Genekam biotechnology AG
has been developing a number of solutions based on magnetic beads. ELISA is one of
common serological methods, which is being used to detect antibodies as well as antigens
for last many decades. ELISA method needs a plastic plate and it takes 7 hours to 2 days
to be performed. It needs instruments as the plates must be kept at particular temperatures.
Therefore, ELISA is being performed in professional laboratories.

Genekam has developed magnetic beads ELISA, which can be performed in anywhere e.g.
in small clinics in the world like in Africa or remote areas of Saudi Arabia as point of care
ELISA can help to detect the cases of coronaviruses as early as possible and the results
can be read with naked eyes also along with reading the results with the machine This
method has biggest advantage against PCR method, where one has to collect the sample
and send to laboratory to perform the diagnosis leading to loss of valuable time as during
this time, the viruses spread while treatment and prevention cannot start properly.
Genekam magnetic beads ELISA is going to change this. Magnetic beads ELISA is far
better than rapid tests, which have very low sensitivity against ELISA even and problem of
cross reactivity as this month studies conducted in Germany shows that rapid tests from
one of biggest biotech company has 70% sensitivity for coronaviruses.

Genekam magnetic beads ELISA can change this because remote rural areas can have
now an access to excellent quality testing system. This test does not need any power
supply and can be performed at room temperature against PCR, where the chemicals must
be frozen. Genekam magnetic beads ELISA detects the presence of antibodies. It can also
indicate whether the person is exposed to coronaviruses infection along with indicating that
the active disease is being developing because infected person is going to develop
symptoms. The cost Euro 1 per test of Genekam magnetic beads ELISA is lower than
ELISA as well as PCR tests. Genekam is trying to develop a new version of this test, where
the cost may go down to 30 cents per test against the ELISA 3 Euro and PCR test 8 Euro.
Genekam Biotechnology AG is a German company focusing on pandemic viruses for last
16 years as it has large number of tests for different pandemic outbreak causing viruses
like Influenza, Zika, Ebola, dengue, coronaviruses, Rift valley virus. It is working on
developing the therapeutic antibodies and small molecules to cure these viruses one day.
It develops and manufactures its products in Germany

Coronaviruses are getting mutated, hence there are different mutations like B117, P1 and
B1.135. These mutations are causing that many PCR tests do not give the correct the
results, hence it leads to false results. Therefore, many manufacturers around the world
as well as FDA have given the warnings as approved kits do not give correct results.
Genekam developed one of the first PCR for detection kit FR475 for SARS CoV-2 in Jan,
2020. This kit FR475 detects the samples with different mutations perfectly, therefore
these mutations have no impact on the results conducted with Genekam kit. This kit has
been used last year in many countries as the countries using Genekam kit have last year
very low incidents of coronaviruses, but with the time, WHO/CDC/FDA/CE approved kits
came on the market, after that the incidents have increased so strongly that many
countries lost their grip on the spreading of this virus. These mutations are increasing with
time; hence all kits being used in coronaviral pandemic outbreak must give an assurance
that approved kits or methods from CDC and WHO detects coronaviruses (SARS Co-V,
Wuhan strain) properly and mutations does not have any impact on their performance.

Genekam FR475 kit is not the only one, which is giving excellent results. In 2016,
Genekam created double check for Zika viruses as there are many strains, which are not
being detected through normal commercial kits of many manufacturers. In 2017,
Genekam kit for Influenza virus H5N1 outperformed the other kits in UEA as it detects
samples from Africa, which were infected with H5N1 against the other commercial kits,
which were fail to detect such infected samples. The tests are conducted in a laboratory in
Abu Dubi. These examples show as this is very important to have a deep knowledge of
virology to develop an excellent kit. Many of companies developing kits for pandemic
viruses do not have very deep knowledge of virology, but they get approve from FDA,
WHO and EU, hence it is time to compare the performance of different kits available on
the market, so that poor quality kits (many of them are coming from big biotech
companies) are removed from the market, but authorities are not interested to do this,
hence this must be discussed in the press. Genekam is requesting such action for last 6
years.

Major mutations N501Y, E484K, N417N/T along many dozens of other common
mutations are matter of concern as N501Y occurs in receptor binding domain leading to
increase in rate of binding between the receptors ACE2 and virus. It means rate of
transmission will increase strongly. As these are mutations in spike and nucleoprotein
regions, hence the immunity can decrease and recovered persons can reinfect, such
mutations may lead to have negative effect on vaccination as well as therapies available
now. Therefore, it is important that laboratories use PCR kits, which detect samples with
mutations too to provide good results. It is possible with Genekam FR475. Genekam
Biotechnology AG is a German company focusing on pandemic viruses for last 16 years
as it has large number of tests for different pandemic outbreak causing viruses like
Influenza, Zika, Ebola, dengue, coronaviruses and Rift valley virus. It is working on
developing the therapeutic antibodies and small molecules to cure these viruses one day.
It develops and manufactures its products in Germany