The BEATsep project will apply an interdisciplinary approach bringing together research and clinical teams working on specific aspects of the development, treatment and prevention of the long-term consequences of sepsis and its impact on patients’ quality of life. Comprehensive clinical and research data generated during the project will be integrated using artificial intelligence algorithms into an easy-to-use predictive tool capable of identifying patients at high risk of complications. BioVariance GmbH is involved here in the development of algorithms that link these collected data. Furthermore, the consortium plans to design a tertiary prevention strategy to improve the recovery outcomes.

For the next five years, the consortium brings six European countries together in a joint mission to understand and fight the long consequences of sepsis.

The consortium is coordinated by ICRC-FNUSA and will consist of leading European institutions including: 1) CIML – Centre d’immunologie de Marseille-Luminy – (Aix-Marseille Université/CNRS/Inserm); 2) Institute of Innate Immunity, at the Medical Faculty of the University of Bonn, Germany; 3) Faculty of Medicine at the Comenius University in Slovakia; 4) Ludwig Boltzmann Institute for Traumatology, Vienna, Austria;  5) BioVariance GmbH, Germany; 6) Masaryk University, Brno, Czechia;  7) National Institute of Health, Prague, Czechia; 8) University of Galway and 9) APHM – Marseille Hospitals. BEATsep assembles renowned experts in immuno-metabolism and epigenetics, immunophenotyping, diagnostic research and several clinical teams treating adult and pediatric sepsis patients. “It has taken nearly two years of intensive preparation and networking to assemble the consortium. We used the advantage of bringing together teams with whom we have been already collaborating on several other projects.” says Dr. Marcela Hortová-Kohoutková from the CMI research group, who co-headed the project’s preparation.

In total, 9 partners from renowned European research and clinical institutions and 1 commercial partner in six EU countries will be involved in the BEATsep. “The project is an example of an innovative and successful combination of translational and clinical research, the know-how of several international scientists, and the collaboration between hospitals, universities and other scientific institutions.

For more information and updates:

www.beatsepsis.eu

https://shorturl.at/isRZ9 (LinkedIN)

Der Beitrag BioVariance is a partner in the EU-funded project “BEATsep”, which aims to combat the long-term effects of sepsis. erschien zuerst auf BioVariance - data-driven diagnostics.

Due to known difficulties and the long outdated topic, the antibody study will not take place as planned. We apologize for this and would be pleased if Ms. Schraml and BioVariance would nevertheless continue to support and participate in our first study on telomere length determination, which can be used to determine a person’s biological age.

Telomere length determination is a fascinating field of research that gives us information about the condition and health of our cells. Telomeres are the protective caps at the ends of our chromosomes that are associated with the aging process. By analyzing telomere lengths, our team can gain important insights into the biological aging process and thus determine biological age. With this telomere length determination study, we are once again setting the standard in medical research and reaffirming our position as a pioneer in the field of biomedical innovation.

To further this important research, we are seeking volunteers of either gender, 18 years of age or older, who are willing to have a sample of their oral mucosa taken with a simple cheek swab. This can be done on-site at our facility or at your home, using a so-called test kit (similar to a rapid PCR test), which we will send to you by mail.

The telomere length determination study will take place in July and offers you the opportunity to participate in groundbreaking research. Interested individuals are welcome to call 09631 / 30 89 200 or email studie@biovariance.com, stating your address, gender and age, for more information and to register to participate.

The results of this research could lead to new insights into the aging process and form the basis for future medical advances.

Der Beitrag Antibody study gives way to the telomere length study erschien zuerst auf BioVariance - data-driven diagnostics.

What is metastatic colorectal cancer?
The third most common type of cancer is colorectal cancer. mCRC is the metastatic type of colorectal cancer being located at the colon or rectal part of the human body. It appears more often in men than in women, but women often suffer from the more aggressive right-sided type of the cancer. The right-sided type of mCRC goes along with a worse prognosis of survival. Generally, one can distinguish between left- and right-sided colorectal cancer, where left-sided mCRC patients have better prognoses concerning the progression-free survival (PFS). The PFS is a factor that measures how long people survive after the cancer treatment without the tumor progressing again. A lot of mCRC cases are related to higher ages, because age is one of the risk factors. Other risk factors are a bad lifestyle (bad diet habits, alcohol consumption, etc) and less frequently also genetic factors.

Classification of mCRC patients is done by the oncologists on basis of anatomical tumor characteristics like grading and staging. Grading indicates how similar a tumor cell is to a normal cell, whereas staging gives information about the size and the spreading of the tumor. Since not all patients have the same present biomarkers (biologically measurable parameters of biological processes, that are known to have prognostic or diagnostic expressive power) and clinical data (measured values like weight, height, blood pressure, vitamin d value etc.), not all treatments will work equally well for all patients. Thus, a more personalized approach is being aspired, where in addition to grading and staging several other molecular biomarkers and individual clinical data of the patient play a more important role in the treatment decision.

What does REVERT mean?
The abbreviation REVERT origins from the long title “taRgeted thErapy for adVanced colorEctal canceR paTients”. REVERT is an international project funded by the EU, that started in 2020 and is planned to end in 2023. Specialists from Italy, Spain, Sweden, Luxembourg, Romania, and Germany were chosen to participate in the project, involving clinicians, pathologists, biologists, software developers, and also artificial intelligence (AI) specialists. BioVariance is part of the work package being responsible for the development of the AI solutions, thus BioVariance will offer some machine learning solutions for the question of the project.

What is the aim of the project?
The project aims at generating the REVERT database of molecular and clinical data collected from several hundred metastatic colorectal cancer patients that had visited one of the participating hospitals located at the different countries within the EU in the past. The database is then used as a basis for machine learning models to aspire a more personalized therapy approach for treating newly diagnosed patients. In the future, the trained AI model will predict a suitable first-line treatment for each new patient, who has not received any cancer medication yet, supporting the clinicians in their treatment decision. In addition to that, a clinical study will be executed with several new patients that decide to participate and want to be treated according to the AI-based results. This prospective clinical study will be performed with already authorized and commonly used chemotherapies and not with new treatments. The expectation concerning the AI-based results is to provide another more objective decision factor for clinicians, that is free from the subjective decision of the attending doctor at the hospital. Finally, the machine learning (ML) solutions will be combined in an app, that can support clinicians in the future.

What is machine learning and how is it used in the context of the project?
Machine learning algorithms use underlying mathematical models to recognize certain patterns in the patient’s data. The primary dataset of the REVERT database contains several processes of cancer treatments, the known survival outcome and about 150 other molecular and clinical features of hundreds of mCRC patients from the last 10 years. According to the underlying mathematical models, it is possible to derive some new rules from this dataset, that make it possible to predict outcomes for each new patient that was not included in the primary data. Therefore, the primary dataset must be used to (i) train and thereby generating ML models and to (ii) test and evaluate these generated models. In addition, the ML models allow to spot important features, that have a strong influence on the outcome prediction. For the primary dataset the actual outcome is already known, allowing us to see for how many patients the model predicted the correct outcome.

In the REVERT project BioVariance’s ML algorithms are used to create models that can classify whether a certain patient is likely to respond to different chemotherapies, that have been approved for years. During the project, several chemotherapies have already been categorized by the clinicians as being equally well for treating mCRC and that are now considered for the project. The related question for the ML algorithms is to predict the first-line treatment (= initial treatment, that is recommended for a disease, here: chemotherapy) having the highest chance of success for a certain patient.

What is the current status of the project and what is still to come?
At the moment, the machine learning models are already trained and tested on the previously collected dataset. BioVariance’s models and the models of three other REVERT members are used to predict the best first-line treatment for real patients participating in a phase two clinical study that started in March this year. The first few patients that were diagnosed with mCRC and enrolled to the study have already been processed with the ML models and were treated according to the model outcomes.

The main focus lays on the continuous improvement of the ML algorithms to get the best predictions possible. In the near future the ML models will be included into the REVERT app interface. This allows clinicians to directly enter patient’s data into the REVERT app and get a prediction for the most suitable first-line treatment on a patient-based level.

This approach is an important step into the direction of personalized medicine, since the huge amount of each patient’s data is intensively analyzed and leads to the best treatment for that patient individually, whereas in the current decision process patients get more or less grouped into stages or grades and are then treated in the same way. Finally, the clinical study will show whether the more personalized approach will be able to improve the survival of the patients.

Der Beitrag BioVariance is a member of the EU-funded REVERT Project erschien zuerst auf BioVariance - data-driven diagnostics.

BioVariance GmbH is a German company specializing in the analysis of health data. The company aims to improve everyone’s health by providing personalized medical recommendations based on big data analytics. Using Big Data analytics and artificial intelligence, BioVariance develops personalized health plans based on each patient’s individual needs.

Dr. Josef Scheiber, BioVariance’s founder and CEO, has been instrumental in the company’s success. His years of experience in health research and data analytics have enabled him to update BioVariance’s technology and develop innovative approaches to improve people’s health.

The CIO Views award is further testament to the excellence of Dr. Josef Scheiber and BioVariance. In a statement, Scheiber said, “I am honored to be recognized by CIO Views as one of the Most Innovative Leaders of 2023. This award is a testament to the commitment and passion we have at BioVariance for improving the health and well-being of every individual. We will continue to work hard to push the boundaries of health research and data analytics and develop innovative solutions to improve the health of people around the world.”

Overall, the CIO Views award is a testament to the innovation and dedication of Dr. Josef Scheiber and BioVariance. With their groundbreaking work in the field of health data analytics, they have the potential to change the future of medicine and improve the lives of millions of people worldwide.

Der Beitrag CIO Views honors Dr. Josef Scheiber as one of the most innovative executives in 2023 erschien zuerst auf BioVariance - data-driven diagnostics.

Further advantages of the technique lie in the ability to scan a single sample for many compounds, and the excellent data quality.

Our goal is to develop custom analyses for our cherished customers and collaborators on demand. Our vision is to extend the human lifespan by simplifying the treatment of complex diseases. In the future, cancer, infectious, neurodegenerative and mental diseases should be as easy to treat as a common cold.

At the moment, our highly skilled and trained personnel is implementing a test to accurately quantify a multitude of vitamins from as little as 20µL of blood (Vit Bs, Ds, A, E, K). Feel free to contact us for more information.

Der Beitrag Investment in high precision diagnostics erschien zuerst auf BioVariance - data-driven diagnostics.

The opening marks an important milestone for BioVariance GmbH as it underscores the growth and expansion of the company, which aims to extend the human lifespan by simplifying the treatment of complex diseases. In the future, cancer, infectious, neurodegenerative and mental diseases should be as easy to treat as a normal cold.

The move is accompanied by a brand relaunch that emphasizes BioVariance’s commitment to improving people’s quality of life by better treating disease. Since its founding in 2013, the company has worked closely with the Bavarian Red Cross, diagnostic and pharmaceutical companies, universities and colleges, and various patient organizations to achieve this goal.

“We have worked hard to update our branding to ensure it reflects our commitment to improving human health,” said Dr. Josef Scheiber. “Our new brand image reflects our goal to make disease as treatable as the common cold. We look forward to working in our new facility and continuing our work to improve people’s quality of life.”

Der Beitrag BioVariance opens new offices and presents itself with a new logo erschien zuerst auf BioVariance - data-driven diagnostics.

Click here for the complete company portraits: www.top100.de/die-top-innovatoren

TOP 100: The competition Since 1993, compamedia has been awarding the TOP 100 seal to medium-sized companies for special innovative strength and above-average innovative success. Since 2002, the scientific management has been in the hands of Prof. Dr. Nikolaus Franke. Franke is founder and director of the Institute for Entrepreneurship and Innovation at the Vienna University of Economics and Business. With 25 research awards and over 200 publications, he is one of the leading innovation researchers internationally. The mentor of TOP 100 is science journalist Ranga Yogeshwar. Project partners are the Fraunhofer Society for the Promotion of Applied Research and the BVMW association of small and medium-sized enterprises. The magazines manager magazin and impulse accompany the company comparison as media partners.

More info at www.top100.de. More information as well as general photo material on the TOP 100 competition can be found on the Internet at www.top100.de/presse or by sending an e-mail to presse@compamedia.de. Helen Schneider of BioVariance has more information on the award-winning company.

Contact Helen Schneider | Sales helen.schneider@biovariance.com Press release as download

Der Beitrag Success at TOP 100: Ranga Yogeshwar honors BioVariance erschien zuerst auf BioVariance - data-driven diagnostics.

qPCR diagnostics in the BioVariance lab

The abbreviation „qPCR“ stands for “quantitative polymerase chain reaction”. SARS-CoV-2 is a so-called RNA virus, that means that its genome consists of RNA and not of DNA like in animals or humans. An organism can be clearly identified by analyzing its genome, which is the main point of the PCR analysis. A pharyngeal sample contains RNA in the form of potential viruses as well as DNA in the form of human mucosal cells. Therefore, the contained RNA is isolated and purified before the actual PCR. This RNA is then converted to DNA using the enzyme reverse transcriptase, because the PCR can only work with DNA. After this process the actual PCR starts: The process being called “amplification”, characteristic segments of the produced DNA are multiplied using the enzyme polymerase. BioVariance targets 3 specific DNA segments, while 2 of them belong to genes found in SARS-CoV-2: The RdRP gene, which exists only in SARS-CoV-2 specifically. And the E gene, which occurs generally in the subgenus Sarbecovirus, whereto also SARS-CoV-2 belongs. The evidence of the RdRP gene alone would be enough to identify a sample as positive, but BioVariance presupposes the detection of both virus genes for the generation of a positive report to avoid wrong-positive results. The third targeted segment, the RNAse P gene, is a human gene, which serves as an internal control factor for checking whether the sample contains enough biological material to avoid wrong-negative results.

Evaluation of the PCR analysis

  But how can we check whether the amplification is successfull? Using a special PCR cycler (see Fig. 1), fluorescence markers are embedded into the multiplied DNA sequences during the PCR. Every target sequence is associated with another fluorescence colour. The more DNA is produced by the polymerase, the stronger is the fluorescence of the sample in the real time measurement. For generating an unequivocal result – no matter if negative or positive – the fluorescence signal of the human RNAse P gene must be sufficient. If there is additional fluorescence of both virus genes, the sample will be marked positive. The Ct value serves as a scale unit for the number of existing genes. It describes the number of DNA multiplication steps being necessary to differentiate the fluorescence signal clearly from the so-called background noise and to generate a reliable test signal. The lower the Ct value is, the higher is the number of existing target genes and thus the number of virus particles. Conversely, a high Ct value shows a low concentration of virus particles. During the PCR, the fluorescence signal arises until it peaks after about 1 hour. After this peak it flattens out because the added components for DNA multiplication are used up. This process creates the typical sigmoidal curve of the fluorescence (see Fig. 2).  

  But even the best procedure is subjected to limitations. In about 1 % of cases the result of the PCR is not unequivocal, because the sample material is insufficient or the fluorescence signal is too low, for example. In these cases, the PCR is repeated to gain a clear result.

Identification of virus variants using qPCR

In the BioVariance lab all positive samples additionally undergo a special variant PCR analysis to identify the respective SARS-CoV-2 variant, targeting several SARS-CoV-2 specific gene segments containing the yet known mutations. These analyses revealed that in the last weeks the former virus, the so-called wildtype, was gradually replaced by the British variant B.1.1.7, today called “Alpha“, in the county of Tirschenreuth. Furthermore, positive samples are also sent to a partner lab of BioVariance for further variant analyses, so that new and yet unknown mutations can be identified.

Screening of schools using pooled gargle samples

In May 2021, BioVariance has introduced a new pooling procedure, with several schools in the county of Tirschenreuth participating in the context of a study. This procedure does not need the pupils to take a nose or pharyngeal sample, but only to gargle with some tap water in the morning at home. At school, these gargle samples are “pooled” per class, that means mixed in one sample cup (see Fig. 3). Thus, only one PCR analysis has to be done for each class. Only if a pool sample is positive, the gargle samples of the referring pupils will be analyzed individually. This process allows great savings of lab resources while maintaining a high quality of results.  

Quality management in the BioVariance lab

BioVariance regularly faces external evaluations to ensure the quality and safety of their PCR analyses. For these so-called ring trials, the lab receives several unknown samples from a central office. Only if all samples are identified correctly as negative or positive, the lab will pass the trial and gain a certificate. In May 2021, BioVariance has passed again the external test from the European Society for External Quality Assessment (ESfEQA). Further, all incoming samples are treated under sterile conditions and conforming with strict hygienic regulations in the BioVariance lab, avoiding the contamination of the workstations and a possible infection of employees (see Fig. 4).  

Speed of PCR diagnostics in the BioVariance lab

In Germany, it usually takes 24-48 hours until a tested person receives the PCR result. In the BioVariance lab, results can be produced in less than 3 hours after the samples arrived in the lab. So 99 % of the tested people receive their result at the same day. Two special components allow BioVariance to reach this speed: On the one hand, BioVariance uses an optimized procedure for the RNA extraction which guarantees high efficiency, precision and safety. On the other hand, the IT specialists of BioVariance developed a purpose-built software called TubeLab enabling the digital monitoring of the lab processes, which clearly accelerated and facilitated the handling of samples. Using TubeLab for a transparent tracing and documentation, the BioVariance lab meets the highest requirements. Besides, the partner lab doing the further sequencing of the positive samples also uses TubeLab for monitoring their PCR analyses since April 2020. BioVariance also increased its personnel and expanded the lab team by 2 technical lab employees and 2 student assistants from the scientific area.

Strategic success in Tirschenreuth

With the help of the administrative district office and the health office, the administrative barriers for the establishment of the diagnostic lab as from 26.02.2021 in Waldsassen could be removed within a very short time. Short ways between the test station and the lab are indispensable for rapid testing. In the best case, both stations are located in the same building like in Waldsassen. And thanks to the BRK, 4 permanent and several mobile test stations could be established. More than 40.000 pharyngeal samples from people living in the county of Tirschenreuth have been analyzed since the commissioning of the lab. Using the highly efficient PCR diagnostics, infected people could be identified and quarantined within a few hours. This fact also had a strong positive influence on the local incidence. In February 2021 when the lab was commissioned, the 7-day-incidence was more than 350 infections per 100.000 inhabitants in the county of Tirschenreuth. Now, 15 weeks later, the region is the first county in Bavaria to show a 7-day-incidence of 0. The effective collaboration of the administrative district office, the health office, the BRK and the BioVariance lab as well as the consistent endurance of the population made it possible to signficantly reduce new infections and to finally conquer the high incidence in the county of Tirschenreuth.

Future orientation of the BioVariance lab

BioVariance aims to expand the application possibilities in the lab and to integrate the diagnostics of cancer diseases into their portfolio, additionally to the existing diagnostics of infectious diseases. The company has always focused on the personalization of cancer diseases by sequencing tumors and using the homemade software OncoVariant. This pioneering step allows the selection of the most suitable therapy for cancer patients individually to achieve the greatest possible effectiveness. Further, BioVariance plans to take advantage of the mass spectrometry, which allows the measurement of metabolic products for example.   Conntact person: Kerstin Hammer

Der Beitrag BioVariance Express-PCR-Lab conquers incidence in the county of Tirschenreuth erschien zuerst auf BioVariance - data-driven diagnostics.

In cooperation with the Administrative District Office, the Health Department, the BRK and some schools in the county of Tirschenreuth, the BioVariance laboratory recently started a pilot project for PCR testing of pupils and their teachers. A new gargle-method has been developed to enable soon the area-wide SARS-CoV-2 testing of all pupils twice a week. .

Here, the pupils gargle with a small amount of tap water at home and divide this sample fifty-fifty into two tubes. At school, the first half of the sample is then poured in a common cup for each class, the second tube is stored individually. This “pool” of several samples is tested for SARS-CoV-2 in the BioVariance laboratory using the established PCR method. The PCR is highly sensitive that even a single positive pupil can be detected in a pool of otherwise negative samples. If the pool result is positive, the corresponding school must be informed immediately. Then the second sample tubes of the class with the positive pool test are collected and tested individually by PCR on the same day to identify the positive person. 

By now, eight schools are participating in this pilot project. More schools are supposed to follow in the next days and weeks. Further, the gargle method is currently also examined for the possible use in day-care centers.

Contact person

Helen Schneider | Sales and distribution

helen.schneider@biovariance.com

Press release for download

Der Beitrag BioVariance Lab successfully performs PCR pooling tests at schools erschien zuerst auf BioVariance - data-driven diagnostics.

BioVariance GmbH from Waldsassen gained the TOP 100 award 2021, which is given to highly innovative medium-sized companies once a year – now for the 28^th time. Before, BioVariance proved its innovative power in a scientific competition.

On behalf of compamedia, the organizer of the TOP 100 innovation competition, Prof. Dr. Nikolaus Franke and his team examined the innovative power of BioVariance based on 120 test criteria in 5 categories: innovation promoting management, innovative climate, innovative processes and organization, outward orientation / open innovation, and innovative success. The examination addresses the questions, whether innovation is the result of organized processes or a random product, that means the repeatability of innovative performances, and whether and how the corresponding solutions succeed on the market (more information about the test criteria on www.top100.de/pruefkriterien). Due to the current situation another category was included in the examination: the reaction of the company to the corona crisis.

BioVariance operates in the healthcare, biotechnology, and pharma sectors, where the company made its mark with the development of innovative AI solutions for precision medicine. In cooperation with physicians, BioVariance offers long-term monitoring of molecular changes in patients to predict the effectiveness, side effects and interactions of drugs, thereby determining the optimal medication and dosage. Furthermore, the company provides individual therapy recommendations for cancer patients based on patient’s genetic fingerprint.  To achieve this, state-of-the-art automatization and parallelization techniques, machine learning, and mathematical algorithms are combined to analyze complex biomedical data.

„Innovative products and services develop in the mind when creativity and personal development are allowed and supported during the work process. We are glad to be one of the most innovative companies in Germany. This encourages us to keep breaking new grounds.”  [Dr. Josef Scheiber, Managing Director of BioVariance]

BioVariance GmbH already ranked first in the Senetics Award category “Most innovative product idea or patent in healthcare” in 2018 and belonged to the “Top 20 Most innovative companies in the area of healthcare technology” according to Technology Innovators in 2019. Furthermore, in 2019, BioVariance was voted one of the most innovative companies of the year by brand eins for the third year in a row.

Prof. Dr. Nikolaus Franke, the scientific leader of TOP 100, is impressed by the awarded medium-sized companies: „The TOP 100 companies systematically concentrate on being highly innovative.”

On November 26^th, there is another reason to celebrate: All of this year’s TOP 100 award winners meet at the 7. German Mid-Tier Summit to receive congratulations from Ranga Yogeshwar. The science journalist has been acting as a mentor in the innovation competition for 10 years.

TOP 100: The competition

Compamedia has awarded the TOP 100 medium-sized companies with excellent innovative power and outstanding innovative success since 1993, with Prof. Dr. Nikolaus Franke being the scientific leader since 2002. Franke is the founder and chairman of the Institute for Entrepreneurship and Innovation at the University of Vienna. 25 gained scientific awards and over 200 publications make him one of the leading innovation researchers in the world. The mentor of TOP 100 is Ranga Yogeshwar. Project partners are the Fraunhofer Society for the Advancement of Applied Research and the German Association for Small and Medium-sized Businesses BVMW. The magazines manager magazin and impulse accompany the comparison of companies as a media partner. For more information and application visit www.top100.de.

Find more information and photo material regarding the TOP 100 competition on www.top100.de/presse, or send an email to presse@compamedia.de. More information about the awarded company can be obtained from Helen Schneider, BioVariance GmbH.

Contact person

Helen Schneider | Sales and Distribution

helen.schneider@biovariance.com

Press release for download

Der Beitrag BioVariance gains TOP 100 award erschien zuerst auf BioVariance - data-driven diagnostics.