Batm Advanced Regulatory News (BVC)

LEI: 213800FLQUB9J289RU66

15 July 2020

BATM Advanced Communications Limited

("BATM" or "the Group")

BATM expands COVID-19 diagnostic tests

Launch of three new test kits to advance the diagnosis of COVID-19 and other respiratory illness

BATM (LSE: BVC; TASE: BVC), a leading provider of real-time technologies for networking solutions and medical laboratory systems, announces the launch of three new diagnostic kits to significantly advance the diagnosis of COVID-19 and other respiratory illnesses.

Highlights

· COVID-19 serologic test upgraded to measure the quantity of antibodies in the blood rather than just the presence or absence

· COVID-19 antigen test upgraded to detect spike (S) gene to enable diagnosis of COVID-19 in people with low viral loads, increasing testing accuracy

· New molecular diagnostics test developed to rapidly identify the specific respiratory virus or bacteria in someone presenting with symptoms of, or suspected to have pre-symptomatic respiratory illness

The Group expects to commence sales and production of the kits at its Adaltis facility in Italy at the end of Q3/beginning of Q4 2020.

COVID-19 serologic test

The Group's serologic test for the detection of COVID-19 antibodies, as announced on 5 May 2020, has been advanced to be able to measure the quantity of antibodies in the blood rather than just identifying their presence or absence (qualitative test). The upgraded test measures both IgM antibodies, which are produced a few days after infection and remain in the blood for a short period, and IgG antibodies, which are longer-term (produced a few days after infection and remain in the blood for a few months) antibodies. It has the same levels of sensitivity and specificity as those of the market-leading brands, with sensitivity of 100.0% and specificity of 99.8%.

This upgraded test was developed by the Group in response to the growing amount of medical research suggesting that the volume of antibodies in the blood of someone who has recovered from COVID-19 is low and declines. This test is designed to support public health authorities and individuals in making informed decisions by knowing the potential level of immunity based on the volume of antibodies detected and their deterioration over time. As such, it is an important tool for estimating herd immunity and the efficiency of future vaccines.

This kit will run on Adaltis instruments as well as on any standard ELISA instrument.

COVID-19 antigen test

The Group has expanded the gene discovery capability of its COVID-19 antigen test to five and, importantly, to include the spike (S) gene. The S gene is the protein that the virus uses to invade human cells. It is present in a person's blood even if they have a very low viral load of COVID-19 (which might otherwise go undetected). As a result, by being able to detect the S gene, this test can provide more accurate results, reducing the risk of false positives and false negatives.

Reducing false negative results will prevent missing real cases, especially those in the early stages of infection, who could unknowingly spread the infection. At the same time, reducing false positive results will avoid the needless quarantining of people who have not actually been infected.

The five gene discovery capability compares with a market standard of one to three gene discovery capability. This kit can run on Adaltis instruments as well as on any standard PCR instrument.

New molecular diagnostics test

The Group has launched a new molecular diagnostics kit that is able to test for multiple respiratory pathogens at the same time. In less than an hour, it can identify the particular cause (pathogen) of a respiratory illness, enabling the correct treatment or action to be rapidly implemented. It can identify and differentiate between all prominent respiratory viruses, including all strains of COVID-19, flu and the common cold. It can also detect the bacteria that cause the serious pulmonary illnesses that are believed to be a secondary infection of COVID-19, such as pneumonia and Legionnaires' disease. This new kit was developed in collaboration with academics at Tor Vergata University in Italy.

The ability to rapidly identify the specific cause of a disease enables the correct treatment to be given more quickly resulting in better patient outcomes. This is particularly important for the coming winter where seasonal colds and flu could appear alongside COVID-19 and patients would present with similar symptoms, with cases already on the rise in parts of the southern hemisphere where winter has begun. The ability to rapidly diagnose the particular illness would help to alleviate some of the heavy strain on the public health systems.

This kit, which is expected to receive CE certification in the coming weeks, can run on all Adaltis instruments as well as on any standard PCR instrument. Further information on the detected viruses are listed in the Notes to Editors below.

Dr. Zvi Marom, Chief Executive Officer of BATM, said: 

"I am delighted to be introducing these three new diagnostic kits that place us at the forefront in the fight against COVID-19. Accurate diagnostics is the only tool that exists that can enable a transition towards normality as we continue to live in the presence of the pandemic. We believe that our new kits can provide a vital resource for public health authorities and we are greatly encouraged that we have already received requests to receive these tests immediately once released.

"I would like to give thanks to our dedicated workforce who do all that is humanly possible to develop industry-leading diagnostic solutions. In particular, special thanks goes to our R&D teams led by Prof. Favaro and Drs. Mattina, Padula and Deangelo, as well as the support team led by Mr. Middleton. Together with those who work on longer term R&D strategy and our partners, they have been able to translate scientific knowhow into real-world products that are being used every day to support public health authorities and their communities in these distressing times."

Enquiries:

Notes to Editors

Viruses detected by new molecular diagnostics test

The Group's new molecular diagnostics kits is able to detect all strains of COVID-19 (229E, HKU1, NL63, OC43) as well as all common respiratory viruses including Flu A&B, RSV A&B (common cold), Adeno Virus, Meta Pseudo Virus and Roca Virus.

It can also detect the bacteria that cause serious pulmonary illnesses as a secondary infection of COVID-19, including Bordetella Pertussis, Legionella pneumophila, Mycoplasma pneumonia and Chlamydiophila pneumonia.

Antibodies and antigens

Antibodies are proteins produced by the body in response to harmful substances called antigens (e.g. a virus). ELISA (enzyme-linked immunosorbent assay) serological tests measure the amount of various antibodies present in the blood when the body is responding to a specific infection, like COVID-19. The ELISA serological test detects the body's immune response to the infection caused by the virus rather than detecting the virus itself - to help identify those who have been infected and developed antibodies that may protect them from future infection.