Kirsten Simon

• Diplom, MBA
• CEO at quo data GmbH

Yeast cells can be utilized as whole-cell biosensors for the detection of an array of target analytes. This technology is derived from the latest molecular biology techniques enabling the modification of the yeast genome to enhance the cells’ metabolic properties. Current methods to produce correctly folded recombinant proteins, particularly recept...

BACKGROUND Protein tumor markers are released in high amounts into the blood in advanced non-small cell lung cancer (NSCLC). OBJECTIVE To investigate the relevance of serum tumor markers (STM) for prognosis, prediction and monitoring of therapy response in NSCLC patients receiving chemotherapy. METHODS In a biomarker substudy of a prospective, mu...

BACKGROUND Programmed cell death receptors and ligands in cancer tissue samples are established companion diagnostics for immune checkpoint inhibitor (ICI) therapies. OBJECTIVE To investigate the relevance of soluble PD-1, PD-L1 and PD-L2 for estimating therapy response and prognosis in non-small cell lung cancer patients (NSCLC) undergoing platin...

Food fraud, even when not in the news, is ubiquitous and demands the development of innovative strategies to combat it. A new non-targeted method (NTM) for distinguishing spelt and wheat is described, which aids in food fraud detection and authenticity testing. A highly resolved fingerprint in the form of spectra is obtained for several cultivars o...

Meat species authentication in food is most commonly based on the detection of genetic variations. Official food control laboratories frequently apply single and multiplex real-time polymerase chain reaction (PCR) assays and/or DNA arrays. However, in the near future, DNA metabarcoding, the generation of PCR products for DNA barcodes, followed by m...

Adverse effects of drug combinations and their underlying mechanisms are highly relevant for safety evaluation, but often not fully studied. Hydroxychloroquine (HCQ) and azithromycin (AZM) were used as a combination therapy in the treatment of COVID-19 patients at the beginning of the pandemic, leading to higher complication rates in comparison to...

Game meat products are particularly prone to be adulterated by replacing game meat with cheaper meat species. Recently, we have presented a real-time polymerase chain reaction (PCR) assay for the identification and quantification of roe deer in food. Quantification of the roe deer content in % (w/w) was achieved relatively by subjecting the DNA iso...

Campylobacter jejuni is the leading bacterial food-borne pathogen in Europe. Despite the accepted limits of cultural detection of the fastidious bacterium, the "gold standard" in food microbiology is still the determination of colony-forming units (CFU). As an alternative, a live/dead differentiating qPCR has been established, using propidium monoa...

Despite known adverse effects of hydroxychloroquine (HCQ) and azithromycin (AZM) on cardiac function, HCQ and AZM have been used as combination therapy in the treatment of COVID-19 patients. Recent clinical data indicate higher complication rates with HCQ/AZM combination treatment in comparison to monotherapy. Here, we used human induced pluripoten...

Detection of food fraud and geographical traceability of ingredients is a continually sought goal for government institutions, producers, and consumers. Herein we explore the use of non-target high-resolution mass spectrometry approaches and demonstrate its utility through a particularly challenging case study - to distinguish wheat and spelt culti...

As the number of people affected by COVID-19 disease caused by the novel coronavirus SARS-CoV-2 ebbs and flows in different national and sub-national regions across the world, it is evident that our lifestyle and socio-economic trajectories will have to be adapted and adjusted to the changing scenarios. Novel forecasting tools and frameworks provid...

In the light of recent food fraud cases, the issue of food authenticity is receiving increasing attention. New analytical methods and evaluation approaches are currently being proposed. In this framework, the evaluation of mass spectral profiles constitutes a promising avenue, e.g. for the determination of food origin. Relevant evaluation approache...

Endocrine-active substances can adversely impact the aquatic ecosystems. A special emphasis is laid, among others, on the effects of estrogens and estrogen mimicking compounds. Effect-based screening methods like in vitro bioassays are suitable tools to detect and quantify endocrine activities of known and unknown mixtures. This study describes th...

Arxula adeninivorans-based yeast cell assays for the detection of steroid hormones demonstrated their efficiency for the determination of total hormone activity in a variety of samples using a microtiter plate format. In this study, a preliminary chromatographic separation using thin-layer chromatography plates is introduced in order to allow a rap...

Background: This meta-analysis evaluated whether pretherapy serum levels of carcinoembryonic antigen (CEA) and cytokeratin-19 fragments (CYFRA 21-1) are predictive of response to therapy in non-small cell lung cancer (NSCLC) and whether changes in these markers during vs pretherapy are indicative of response. Methods: Original peer-reviewed stud...

A biosensor detecting estrogens, progestogens and androgens in complex samples and in a single step is described. Three Arxula adeninivorans yeast strains were created, each strain producing a different recombinant human hormone receptor and a different fluorescent reporter protein. These strains were then mixed to create G1212/YRC102-hHR-fluo, the...

The test methods UN Test L.2 / EN ISO 9038:2013 DIN EN 15188:2007 are applied to characterize the sustained combustibility of liquids i.e. the behaviour of a material under specified test conditions, whereby its vapour can be ignited by an ignition source and sufficient flammable vapour is produced to continue burning for at least 15 s after the so...

Objectives: The aim of this study was to determine whether the Risk of Ovarian Malignancy Algorithm (ROMA) is more accurate than the human epididymis 4 (HE4) or carbohydrate antigen 125 (CA125) biomarkers with respect to the differential diagnosis of women with a pelvic mass. The secondary objective is to assess the performance of ROMA in early-st...

Specific and sensitive analytical methods are needed to guarantee the safety of gluten-free products for coeliac disease patients at the threshold of 20 mg gluten/kg. Immuno-chromatographic assays, usually available in dip-stick or lateral-flow format, provide rapid qualitative results indicating the presence or absence of gluten. In September 2015...

For the classification, safe handling and use of the chemicals, special standardized testing procedures have been developed and are used worldwide. Safety experts must be able to fully rely on the precise execution of the respective laboratory tests and assessments. In this context, interlaboratory tests are a crucial element of a laboratory's qual...

Numerical values called L-scores, with properties similar to those of z-scores, can be calculated for proficiency tests involving qualitative test methods. These scores do not require the use of replicates and are defined in such a way as to reflect both the Level of Competence of the Laboratory (LCL) and the Level of Difficulty of the Task (LDT)....

The two Arxula adeninivorans-based bioassays (A-YGS and A-YGFS) described here provide sensitive and reliable screening for glucocorticoids in aquatic environments. The biocomponents of A-YGS and A-YGFS were constructed to carry the human glucocorticoid receptor (hGRα) and the phytase gene (phyK, derived from Klebsiella sp. ASR1) or a fluorescence...

This study describes the development of a bioassay to detect the presence of progesterone and progesterone-like molecules in wastewater samples. The basis of the bioassay is the integration of the human progesterone receptor gene into the yeast Arxula adeninivorans for the constitutive synthesis of the receptor. After incubation, binding of the ana...

Presence of genetic modifications in rice products originating from China and imported to the European Union market is detected since 2006. Neither these products from China nor any other genetically modified rice lines are approved as food or feed in the EU. The transgenic rice varieties identified contain genetic elements and constructs coding fo...

A new model for the probability of detection (POD curve) for qualitative PCR methods examined in a method validation collaborative study is presented. The model allows the calculation of the POD curve and the limit of detection (LOD 95%), i.e. the number of copies of the target DNA sequence required to ensure 95 % probability of detection. The betw...

We used the interaction between human serum albumin (HSA) and a high-affinity antibody to evaluate binding affinity measurements by the bench-top liSPR system (capitalis technology GmbH). HSA was immobilized directly onto a carboxylated sensor layer, and the mechanism of interaction between the antibody and HSA was investigated. The bivalence and h...

An Arxula adeninivorans based microbial biosensor has been developed for the determination of pharmaceuticals and chemicals such as omeprazole, lansoprazole, ß-naphtoflavone and methylcholanthrene within 5 hours using biochemical detection and 4 hours and 10 minutes using amperometric detection. The biosensor consists of genetically modified A. ade...

For the first time, the full length recombinant HER-2[neu] receptor has been produced in a yeast (Arxula adeninivorans). It is one of the most studied membrane receptors in oncology and is involved in aggressive tumor formation. A yeast integration rDNA cassette containing the human gene coding for the HER-2[neu] protein was constructed and a scree...

The novel A-YAS assay for the detection of androgenic activity in liquid samples such as urine has been developed and assessed. The assay is based on transgenic Arxula adeninivorans yeast cells as the bio-component. The cells were engineered to co-express the human androgen receptor (hAR) gene and the inducible phytase reporter gene (phyK, derived...

To improve prognosis of patients with colorectal cancer, powerful blood-based biomarkers enabling for early detection are needed. As genome-wide DNA hypomethylation is associated with carcinogenesis, and cell-free DNA, thought to be of tumor origin, is found in the circulation of patients with cancer, we investigated the relevance of 5-methylcytosi...

Zusammenfassung Für das Datenmanagement bei Messungen der Oberflächenplasmonresonanz (SPR) wurden neue mathematische Verfahren entwickelt und in die eigens entwickelte Software SPRING integriert. Die Software ermöglicht eine Auswertung von SPR-Messdaten und liefert statistisch abgesicherte Aussagen zur Charakterisierung molekularer Interaktionen. V...

The ‘EstraMonitor’ was developed to provide an automated system for the detection of estrogenic compounds. It can be used for semi-online and continuous monitoring without additional instrumentation. Previously it was used to detect pure estrogenic molecules. In this investigation, the ‘EstraMonitor’ is used to detect the estrogenic activity in fiv...

For the classification and safe handling and use of the chemicals, special standardized testing proce-dures have been developed and are used world-wide. Safety experts must be able to fully rely on the precise execution of the respective laboratory tests and assessments. In this context interlaboratory tests (round robin tests, interlaboratory comp...

The EstraMonitor has been developed to provide a device suitable for monitoring estrogens in sewage treatment plants, i.e. provide rapid detection in semi-online operation. This monitor is based on recombinant Arxula adeninivorans yeast cells as the biocomponent. The cells were engineered to co-express the human estrogen receptor α (hERα) gene and...

For the classification of chemicals, special standardized test procedures have been developed and are used world-wide. Safe handling and use of these chemicals depend on the correct classification which therefore must be based on the precise and correct execution of the tests and their evaluation. In this context interlaboratory tests (round robin...

A novel Arxula adeninivorans yeast estrogen screen (nAES) assay has been developed for detection of estrogenic activity in various liquid samples such as wastewater, seawater, brackish water and swine urine. Two bio-components were engineered to co-express the human estrogen receptor α (hERα) and an inducible reporter gene; either the non-conventio...

The classification of solid oxidizers according to the GHS (Globally Harmonized System of Classifica-tion and Labelling of Chemicals) and according to regulations on the transport of dangerous goods (based on the UN Recommendations/Model Regulations and implemented in all carrier domains as transport by road, railway, sea, air) is performed on the...

Comprehensive validation of any measurement method is required in order to make different methods comparable and acceptable in front of the law. Each method validation aims at obtaining suitable indicators for assessing the efficiency of an analytical procedure, i.e., in particular those indicators that characterize analytical errors. Correctness a...