Biotype Diagnostic GmbH

Dresden, Germany

Biotype Diagnostic GmbH

Dresden, Germany

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News Article | November 10, 2016
Site: www.newsmaker.com.au

Cancer is characterized by the growth of abnormal cells that divide uncontrollably and have the ability to infiltrate and destroy normal body tissue. Cancer is triggered by both external factors such as tobacco, chemicals, alcohol, infectious organisms, sun exposure and internal factors such as hormones, inherited gene mutations, immune conditions and abrupt mutations. Cancer can start almost anywhere in the human body and has the ability to spread all over the body. Cancers are majorly solid tumors (tissue masses) and blood cancers (leukemia). There are more than 100 types of cancers such as lung cancer, colorectal, breast, blood cancers, etc. Cancer is the second-leading cause of death in the United States. But survival rates have improved for many types of cancer due to continuous development of screening and treatment procedures. The most common cancer diagnostic methods are biopsy, sentinel node biopsy, endoscopy, blood tests, bone marrow aspiration, Pap test, sputum and bronchial washing analysis, imaging studies, genetic analysis, etc. The diagnosis of cancer involves collection of patient samples such as a cell or tissue or cells’ proteins, DNA, and RNA followed by detection of specific cancer. Cancer diagnostics market is witnessing high growth due to increasing prevalence and incidences of several types of cancers. Major drivers for the global cancer diagnostic market are technologically advanced and increasing point-of-care diagnostics, cost-effective treatment modalities, and personalized medicine. Additionally, increasing persistence to provide best-in-class healthcare services with high accuracy and efficiency towards patient is expected to fuel the global cancer diagnostics market across the globe. However, lack of adequate reimbursement policies for novel technologies and stringent regulatory procedures particularly for United States are the major factors that can hamper the global cancer diagnostics growth over the forecast period. The global cancer diagnostics market has been classified on the basis of product, application, end use and geography. Based on product type, the global cancer diagnostics market is segmented into the following: Based on application type, the global cancer diagnostics market is segmented into the following: Based on end use type, the global cancer diagnostics market is segmented into the following: North America was the key region in global cancer diagnostics market in terms of revenue in 2014, followed by Europe. The first FDA-cleared assay for breast cancer diagnosis was In Vitro Diagnostic Multivariate Index Assays (IVDMIA). The "MammaPrint" and “BluePrint” assays for breast cancer diagnosis and a microarray-based gene expression assay "ColoPrint" for predicting the recurrence of stage II and III colon cancer, has recognized the potential of cancer/tumor profiling in diagnostics and prognosis. This scenario is anticipated to revolutionize the cancer diagnostics companies and boost growth in global cancer diagnostics market in the coming five to 10 years.  By product type, genomic biomarkers are dominating as compared to other product types in global cancer diagnostics market. For instance, GUARDANT360 blood test, next generation sequencing test 'Cologuard', Cobas HPV Test, and myRisk Hereditary Cancer multigene molecular diagnostic test are few examples of genomic biomarkers. By end use, hospitals and diagnostic centres segments held 50% share in the global cancer diagnostic market and the trend is forecast to continue through 2025. The altering regulatory consequences among the high growth countries of Asia Pacific is attracting the leading companies in the global cancer diagnostics market. Key players of cancer diagnostics market are M Genomics Ltd., Abbott Laboratories,  Agena Bioscience Inc., Alere Inc., Astra Biotech GmbH, bioMérieux SA, BioMosaics, Biotype Diagnostic GmbH, Cancer Genetics, Inc., CDx Diagnostics, Celerus Diagnostics, Inc., Cube Dx GmbH, Dako A/S (an gilent company), EntroGen, Inc., Epigenomics AG, Exact Sciences Corporation, GE Healthcare, Genalyte, Inc., GeneCentric Diagnostics, Inc., GeneDx,., Genomic Vision, Genoptix (a Novartis company),  Hologic, Inc., Illumina, Inc., Inform Genomics, Inc., Mayo Medical Laboratories and Mayo Clinic, MBL International Corporation, NanoIVD, Inc., NanoString Technologies, Inc., NewGene Ltd., OncoPlex Diagnostics (OncoPlexDx), Oncospire Genomics, Oxford Cancer Biomarkers Ltd., Oxford Gene Technology, PrognosDx Health, Inc., Provista Diagnostics, Inc., QuantuMDx Group, Quest Diagnostics, Rheonix, Inc., Rosetta Genomics Ltd., Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Inc., Transgenomic, Inc., TrimGen Corporation, TrovaGene, Inc., Ventana Medical Systems, Inc. Getting regulatory approvals for in vitro cancer diagnostics in Europe is easy as compared to United States. So preferably most of the cancer diagnostic companies are launching their new innovative products in Europe and consequently applying for FDA in the United States.


Mehlig L.,University Hospital Carl Gustav Carus | Garve C.,University Hospital Carl Gustav Carus | Ritschel A.,University Hospital Carl Gustav Carus | Zeiler A.,Biotype Diagnostic GmbH | And 3 more authors.
Mycoses | Year: 2014

Summary: Dermatomycoses are very common worldwide with increasing prevalence. An accurate and rapid detection of fungi is most important for the choice of antimycotics and the success of treatment. The aim of this study was to evaluate a new commercial multiplex-based PCR which allows the detection and differentiation of the most relevant human pathogen fungi causing dermatomycoses in Europe. The accuracy and reproducibility of this application were verified in a clinical performance assessment in comparison to direct microscopy and culture using DNA isolates from 253 clinical samples. Sensitivity, specificity, positive predictive value and negative predictive value of 87.3%, 94.3%, 87.3% and 94.3%, respectively, were calculated for dermatophytes when confirmed by direct microscopy, culture or both. The corresponding values for Candida spp. were 62.7%, 93.5%, 77.8%, and 87.4%, respectively. Furthermore, in comparison to culture, the multiplex PCR was able to detect additional 38 Trichophytum rubrum and 12 Trichophytum interdigitale infections. These results were confirmed by independent PCR analysis. From DNA isolation to diagnosis the multiparameter diagnostic kit gives rise to a 1-day workflow, enables fast clarification of disease aetiology and, thus, contributes to specific therapy selection. The latter is particularly important in light of growing resistance to antimycotics. © 2013 Blackwell Verlag GmbH.


Stahl T.,University of Hamburg | Rothe C.,Biotype Diagnostic GmbH | Bohme M.U.,Biotype Diagnostic GmbH | Kohl A.,University of Hamburg | And 2 more authors.
International Journal of Molecular Sciences | Year: 2016

Accurate and sensitive determination of hematopoietic chimerism is a crucial diagnostic measure after allogeneic stem cell transplantation to monitor engraftment and potentially residual disease. Short tandem repeat (STR) amplification, the current “gold standard” for chimerism assessment facilitates reliable accuracy, but is hampered by its limited sensitivity (≥1%). Digital PCR (dPCR) has been shown to combine exact quantification and high reproducibility over a very wide measurement range with excellent sensitivity (routinely ≤0.1%) and thus represents a promising alternative to STR analysis. We here aimed at developing a whole panel of digital-PCR based assays for routine diagnostic. To this end, we tested suitability of 52 deletion/insertion polymorphisms (DIPs) for duplex analysis in combination with either a reference gene or a Y-chromosome specific PCR. Twenty-nine DIPs with high power of discrimination and good performance were identified, optimized and technically validated. We tested the newly established assays on retrospective patient samples that were in parallel also measured by STR amplification and found excellent correlation. Finally, a screening plate for initial genotyping with DIP-specific duplex dPCR assays was designed for convenient assay selection. In conclusion, we have established a comprehensive dPCR system for precise and high-sensitivity measurement of hematopoietic chimerism, which should be highly useful for clinical routine diagnostics. © 2016 by the authors; licensee MDPI, Basel, Switzerland.


Kick A.,TU Dresden | Bonsch M.,TU Dresden | Katzschner B.,TU Dresden | Voigt J.,TU Dresden | And 8 more authors.
Biosensors and Bioelectronics | Year: 2010

We report on the development of a new platform technology for the detection of genetic variations by means of surface plasmon resonance (SPR) spectroscopy. TOPAS chips with integrated optics were exploited in combination with microfluidics. Within minutes, the detection of hybridization kinetics was achieved simultaneously at all spots of the DNA microarray. A nanoliter dispenser is used to deposit thiol-modified single-stranded probe DNA on the gold surface of the chips. We investigated the influence of different parameters on hybridization using model polymerase chain reaction (PCR) products. These PCR products comprised a single-stranded tag sequence being complementary to an anti-tag sequence of probes immobilized on the gold surface. The signals increased with increasing length of PCR products (60, 100 or 300 base pairs) as well as with their concentration. We investigated hybridizations on DNA microarrays comprising 90 spots of probe DNA with three different sequences. Furthermore, we demonstrate that sequences with possible hairpin structures significantly lower the binding rate, and thus, the SPR signals during hybridization. © 2010 Elsevier B.V.


Stahl T.,University of Hamburg | Bohme M.U.,Biotype Diagnostic GmbH | Kroger N.,University of Hamburg | Fehse B.,University of Hamburg
Experimental Hematology | Year: 2015

Analysis of hematopoietic chimerism after allogeneic stem cell transplantation represents a crucial method to evaluate donor-cell engraftment. Whereas sensitivity of classical approaches for chimerism monitoring is limited to ≥1%, quantitative polymerase chain reaction (qPCR)-based techniques readily detect one patient cell in >1,000 donor cells, thus facilitating application of chimerism assessment as a surrogate for minimal residual disease. However, due to methodologic specificities, qPCR combines its high sensitivity with limited resolution power in the state of mixed chimerism (e.g., >10% patient cells). Our aim was to overcome this limitation by employing a further development of qPCR, namely digital PCR (dPCR), for chimerism analysis. For proof-of-principle, we established more than 10 dPCR assays detecting Indel polymorphisms or Y-chromosome sequences and tested them on artificial cell mixtures and patient samples. Employing artificial cell mixtures, we found that dPCR allows exact quantification of chimerism over several orders of magnitude. Digital PCR results proved to be highly reproducible (deviation<5%), particularly in the "difficult" range of mixed chimerism. Excellent performance of the new assays was confirmed by analysis of multiple retrospective blood samples from patients after allogeneic stem cell transplantation, in comparison with established qPCR (14 patients) and short-tandem repeat PCR (4 patients) techniques. Finally, dPCR is easy to perform, needs only small amounts of DNA for chimerism assessment (65ng corresponds to a sensitivity of approximately 0.03%), and does not require the use of standard curves and replicate analysis. In conclusion, dPCR represents a very promising method for routine chimerism monitoring. © 2015 ISEH - International Society for Experimental Hematology.


PubMed | Biotype Diagnostic GmbH and University of Hamburg
Type: Journal Article | Journal: Experimental hematology | Year: 2015

Analysis of hematopoietic chimerism after allogeneic stem cell transplantation represents a crucial method to evaluate donor-cell engraftment. Whereas sensitivity of classical approaches for chimerism monitoring is limited to 1%, quantitative polymerase chain reaction (qPCR)-based techniques readily detect one patient cell in >1,000 donor cells, thus facilitating application of chimerism assessment as a surrogate for minimal residual disease. However, due to methodologic specificities, qPCR combines its high sensitivity with limited resolution power in the state of mixed chimerism (e.g., >10% patient cells). Our aim was to overcome this limitation by employing a further development of qPCR, namely digital PCR (dPCR), for chimerism analysis. For proof-of-principle, we established more than 10 dPCR assays detecting Indel polymorphisms or Y-chromosome sequences and tested them on artificial cell mixtures and patient samples. Employing artificial cell mixtures, we found that dPCR allows exact quantification of chimerism over several orders of magnitude. Digital PCR results proved to be highly reproducible (deviation<5%), particularly in the difficult range of mixed chimerism. Excellent performance of the new assays was confirmed by analysis of multiple retrospective blood samples from patients after allogeneic stem cell transplantation, in comparison with established qPCR (14 patients) and short-tandem repeat PCR (4 patients) techniques. Finally, dPCR is easy to perform, needs only small amounts of DNA for chimerism assessment (65ng corresponds to a sensitivity of approximately 0.03%), and does not require the use of standard curves and replicate analysis. In conclusion, dPCR represents a very promising method for routine chimerism monitoring.


PubMed | Biotype Diagnostic GmbH and University of Hamburg
Type: Journal Article | Journal: International journal of molecular sciences | Year: 2016

Accurate and sensitive determination of hematopoietic chimerism is a crucial diagnostic measure after allogeneic stem cell transplantation to monitor engraftment and potentially residual disease. Short tandem repeat (STR) amplification, the current gold standard for chimerism assessment facilitates reliable accuracy, but is hampered by its limited sensitivity (1%). Digital PCR (dPCR) has been shown to combine exact quantification and high reproducibility over a very wide measurement range with excellent sensitivity (routinely 0.1%) and thus represents a promising alternative to STR analysis. We here aimed at developing a whole panel of digital-PCR based assays for routine diagnostic. To this end, we tested suitability of 52 deletion/insertion polymorphisms (DIPs) for duplex analysis in combination with either a reference gene or a Y-chromosome specific PCR. Twenty-nine DIPs with high power of discrimination and good performance were identified, optimized and technically validated. We tested the newly established assays on retrospective patient samples that were in parallel also measured by STR amplification and found excellent correlation. Finally, a screening plate for initial genotyping with DIP-specific duplex dPCR assays was designed for convenient assay selection. In conclusion, we have established a comprehensive dPCR system for precise and high-sensitivity measurement of hematopoietic chimerism, which should be highly useful for clinical routine diagnostics.


Kick A.,TU Dresden | Bonsch M.,TU Dresden | Mertig M.,TU Dresden | Herr A.,Biotype Diagnostic GmbH | And 3 more authors.
Proceedings of IEEE Sensors | Year: 2010

The detection of DNA hybridization in medical diagnostics ought to be rapid, sensitive and specific. A platform technology based on surface plasmon resonance (SPR) is presented. We use TOPAS® chips with integrated optics and combined with microfluidics. Applying a nanoliter dispenser, thiol-modified single-stranded probe DNA (anti-tag) is deposited on the gold surface of the chips to create a DNA microarray. We fabricate chips with sufficiently high probe density, which is a key factor for DNA chips and can be controlled by adding MgCl2 to the immobilization solution. This technology offers the possibility of detecting PCR products comprising a single-stranded tag sequence being complementary to an anti-tag sequence of immobilized probes on the microarray. Consequently, this universal platform can be applied for detection of DNA hybridization based on the tag/anti-tag system. We demonstrate detection of specific hybridization of different 300 base pairs-long PCR products by SPR within less than five minutes. We checked for expected cross hybridizations with seven base pairs-long sequences at different positions in the tag/anti-tag sequence. Depending on the distance to the sensor surface we could observe crosshybridization if the according complementary sequence part is more distant from the surface. The initial binding rates (response units/min) at different PCR product concentrations were determined. Within five minutes a PCR product concentration of 2.6 nM is sufficient for distinct detection without crosshybridizations. ©2010 IEEE.


Toma M.I.,Carl Gustav Carus Institute | Wuttig D.,TU Dresden | Kaiser S.,TU Dresden | Herr A.,Biotype Diagnostic GmbH | And 7 more authors.
Genes Chromosomes and Cancer | Year: 2013

PARK2 is an E3 ligase, known to be involved in ubiquitination of several proteins and to play a role in neuronal protection. The gene PARK2 and its potentially co-regulated gene PACRG have been previously found to be deleted in clear-cell renal cell carcinomas (ccRCCs). The aim of our study was to evaluate the mRNA and protein expression of PARK2 and PACRG in a large cohort of ccRCC, and to investigate their association with outcome. The expression of both genes was measured by quantitative PCR in 94 primary ccRCCs and autologous nonmalignant kidney tissues. PACRG and PARK2 protein expression was determined immunohistochemically using tissue microarrays comprising 133 ccRCCs. The mRNA and protein expression of PARK2 and PACRG was significantly downregulated in ccRCCs compared with nonmalignant tissues. Low levels of PARK2 mRNA were associated with high-grade ccRCC and lymph node metastasis. Patients with low PARK2 mRNA levels showed a higher tumor-specific mortality rate and a shorter overall survival (OS) than those with high PARK2 expression. Patients without PACRG mRNA expression in the tumor had a shorter disease-free survival and OS than those with tumors expressing PACRG. In multivariate analyses, neither PARK2 nor PACRG expression were independent prognostic factors. The protein expression of PARK2 and PACRG was significantly downregulated in ccRCCs (82.8, and 96.9%, respectively), but no association with clinical outcome was noticed. © 2012 Wiley Periodicals, Inc.

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