by Niels Kruize, CCO, MolGen “Automation and industrialization of COVID-19 PCR-testing will facilitate an immense scale-up of the global PCR-testing capacity. It will allow for a new approach to keep society open: preventive, regular testing (twice per week), which will create green bubbles and get us ahead of the curve” – Niels Kruize, CCO, MolGen
IONTAS and FairJourney Biologics, leaders in the discovery and optimisation of fully human antibodies, have announced the identification of neutralizing antibodies, which bind to multiple emerging SARS-CoV-2 variants. The results, generated from a combination of phage display technology and B-cell receptor repertoire sequencing of hospitalized COVID-19 patients, have identified potent neutralizing antibodies with distinct mechanisms of action. Based on this approach, the Company has developed a panel of therapeutic candidates.
SARS-CoV-2 virus enters the body as a result of the viral spike protein binding to the ACE2 protein on the surface of lung cells. This interaction is driven by a small region of the spike protein and the majority of antibodies currently undergoing clinical trial bind to this site. However, this site has changed in some of the emerging viral variants, reducing or abolishing the effect of some clinical candidates. Drug candidate antibodies developed by IONTAS to this same site have been shown to retain binding to the emerging variants.
An alternative approach for tackling variants is to target alternative regions of the virus which have a greater degree of conservation, making escape variants less likely. GSK/VIR Biotechnology recently announced a successful Phase 3 trial of such an antibody. VIR-7831 is an antibody which binds to a region of the spike protein which is highly conserved between SARS-CoV-2 and SARS-CoV-1 (A distantly related virus responsible for the outbreak of Severe Acute Respiratory Syndrome in 2003). VIR-7831 has shown an 85% reduction in hospitalisation and death during the COMET-ICE clinical trial.
A sub-set of the IONTAS antibodies, show a similar functionality to VIR-7831, by binding to sites conserved both in the recently emerging SARS-CoV-2 variants as well as to the more distantly related SARS-CoV-1 virus.
Dr John McCafferty, CSO at IONTAS, commented: “The first wave of antibody drugs for treating COVID-19 was focused on achieving maximal neutralization to the original SARS-CoV-2 strain first identified in Wuhan. This led many companies to a target site on the virus which is very effective for neutralization but also prone to genetic change. Second generation drug candidates need to anticipate the emergence of new variants by targeting more conserved sites. IONTAS has identified drug candidates which neutralize by targeting conserved regions of the virus. We now seek partners to help develop these to better position the world in tackling this dreadful disease.”
In response to the ongoing COVID-19 pandemic, Erba Mannheim has launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.
To overcome challenges in older COVID-19 molecular tests, Erba’s Cambridge(UK)-based development team has engineered a new assay to improve detection and ease of use with a single tube multiplex mastermix, compatible with room-temperature storage and transportation.
The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequences to maximise long term performance. Sample types include both nasopharyngeal and oropharyngeal swabs as well as saliva.
Nikhil Vazirani, MD of Erba, said: “We are proud and excited to add a highly sensitive RT-PCR test to our growing range of immunoassay and molecular solutions. The new ErbaMDx SARS-CoV-2 test perfectly complements our successful COVID-19 IgG and IgM ELISA assays to offer customers a state-of-the-art molecular test in addition to antibody testing which will offer clinicians valuable insight into the immune response to infection or vaccination.”
The CE-marked kit will be available through Erba’s global distribution network.
Erba Mannheim, established in over 100 countries, focusses on delivering innovative, affordable and sustainable diagnostic solutions to labs everywhere. The Erba group uses a combination of cutting-edge R&D in 4 continents with efficient low-cost manufacturing to make diagnostic technologies accessible in all resource settings.
ZTA Biotech, a Budapest-based biotech startup has announced the breakthrough development of a COVID-19 antibody (IgG) test using the ELISA protocol. This new detection method represents a great step forward in determining if patients have had COVID-19 and if they might still have immunity to the disease. Early results have proven 100% in specificity after testing 280 samples, and 100% sensitivity by testing 260 samples of recovered and symptomatic patients.
Siemens Healthineers molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is ready for immediate rollout for diagnostic use in Europe. This follows registration of the test kit for diagnostic use with the Luxembourg Ministry of Health. The test kit was released for research use only (RUO) on April 2, 2020.
The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. Up to 32 patient samples can be analysed per kit.
The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May 2020. The FTD SAR-CoV-2 Assay can be run in laboratories simultaneously with FTD Respiratory Pathogens 21 and FTD FLU/HRSV, molecular syndromic testing panels from Siemens Healthineers that identify a wide range of pathogens that can cause acute respiratory infections.
Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers, commented: “Having our molecular assay available for diagnostic use throughout the European Union is a major step forward in our contribution to the fight against the global pandemic. I am grateful for the work and achievement of our Siemens Healthineers teams under difficult circumstances, and I hope our clinical test will help the healthcare professionals who are working on the frontlines of the pandemic and those affected by COVID-19.”
The company is also working to expand its infectious disease testing capabilities to address the COVID-19 pandemic in other areas of diagnostics. On April 23, the company announced it is developing a SARS-CoV-2 serology assay to detect IgM and IgG antibodies in blood, helping indicate whether a person has developed immunity against SARS-CoV-2.
Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) as well as the CE Mark.
The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.
Data from a new study suggests that a medical device that uses vitamin B2 and ultraviolet light for treating human blood products is effective against the virus that causes COVID-19. The study results, generated by Terumo BCT in collaboration with researchers from Colorado State University, have been accepted for publication by Vox Sanguinis, a peerreviewed medical journal covering hematology. While there is no evidence that blood transfusions transmit COVID-19, some blood centres are using Mirasol to treat platelets and plasma as an additional layer of safety. Some healthcare providers also treat convalescent plasma with Mirasol. The International Society for Blood Transfusion (ISBT) Global Blood Safety Working Party recommends, where feasible, pathogen inactivation of plasma to control residual risks of transfusion transmitted infection diseases and to allay concern about possible superinfections with SARS-CoV-2.
Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.
Mirasol is CE marked for platelets, plasma and whole blood and is in routine use in more than 20 countries throughout Europe, the Middle East, Africa, Asia and Latin America. The system is not approved for sale in the U.S. and Canada.
In response to the global COVID-19 pandemic, Beckman Coulter, a global leader in clinical diagnostics, announced 31 March that it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG tests.
The assays will be designed for use on any of Beckman Coulter’s high-throughput Access family of immunoassay systems, including the Access 2 and DxI series, which can be found worldwide.
“Antibody assays play a critical role in understanding the level of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, Senior Vice President and General Manager for Beckman Coulter’s Chemistry and Immunoassay Business. “This type of understanding could help identify those who would require a vaccine, once available, or when an infected individual could safely return to work.”
Shamiram R. Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter, added: “With the ability to assess a patient’s immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that they have had prior exposure and therefore have built an immunity to the disease. This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Beckman Coulter operates within the Danaher Corporation, together with a collection of the world’s leading diagnostic companies, all on the front line in the fight against coronavirus.
Once the assays are finalized, Beckman Coulter intends to achieve CE mark certification and to follow FDA’s Emergency Use Notification process.
For the latest information on the new assays, visit www.beckmancoulter.com/coronavirus
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