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THE TECHNOLOGY

Molecular Diversity Helps Understand Therapy Effectiveness

We often hear the phrase, “Let’s celebrate diversity.” At Nuvera, we celebrate molecular diversity and its relationship to disease for better management. Underneath all disease lie complex molecular mechanisms that play a role in causation, progression, and more importantly, its arrest and control. This complexity and diversity at the molecular level is the path to understanding and treating disease.

Nuvera’s technology, simply put, makes better sense of the embedded molecular complexity within disease by picking up the most relevant pieces that correspond to therapy response and effectiveness.

Diagnostic Tests from Molecular Analysis

Nuvera combines analyses at the molecular level with biocomputational data analyses to tease out specific traits that will help identify and predict response to therapy in a patient. With significant advances in analytical technologies to-date, comprehensive molecular characterization can now be done on genetic sequence, gene expression, protein concentrations, or metabolite levels. All of these molecular factors, ranging from genetic to metabolic information, when compared between normal and disease conditions, will identify certain differences that contribute individually or in tandem to disease occurrence and its response to treatment.

Nuvera has actively collaborated with academic partners to obtain high-quality patient samples necessary for study of therapy effects and to generate a wealth of molecular and clinical outcome data from their laboratories and clinical trials. These data allow a concerted examination of molecular factors that correlate with disease outcome after administration of standard therapy regimens.

Nuvera has developed unique bioinformatics algorithms and data processing techniques tailored for the specific nature of molecular data at the genetic, protein or metabolite level. Using these bioinformatics analyses, Nuvera identifies distinct molecular patterns as tell-tale signs of the selected disease endpoint. Employing additional analyses to refine the molecular patterns and understand the biological mechanisms within them, the molecular factors are then combined together into a diagnostic prediction algorithm for therapy effectiveness.

Diagnostic Assays are Validated in Clinical Trials

The predictive assay will have value in clinical practice only if it demonstrates a benefit of therapy selection to the patient by improving outcomes. Nuvera conducts clinical trials with leading centers across the world to test samples of patients who have undergone standard therapy combinations and report whether the prediction of response prior to therapy assignment would reduce risk of relapse and improve survival of patients.

By building our relationships with leading academic collaborators and demonstrating the performance of its diagnostic assays in multi-center clinical studies, Nuvera continues to build its portfolio of molecular diagnostic assays directed at therapy effectiveness and better personalized disease management.

Information Management

Nuvera has developed considerable expertise in management and analysis of biological data in order to perform the required diagnostic analyses and optimization. Information is collated from a variety of sources related to patient demographics, clinical data, routine pathology test results, follow-up and outcomes, and vast amounts of data from molecular profiling of each patient sample. Getting these data ready for meaningful analysis requires that the collation is done for each patient consistently and in a highly structured manner. The integrity of the database is critical to the quality of the analyses performed.

Data management is central to high-quality analyses

Patient records consist of valuable information that can help not only molecular “fingerprinting” but also the understanding of inherent factors related to the individual and their lifestyle that may lead to the disease condition, its progression and overall risk. Nuvera has developed data processing techniques for handling large amounts of longitudinal medical information into a structure that allows easy retrieval, trending, reporting, and analysis. These techniques for warehousing information are not only an important asset for Nuvera’s efforts in personalized diagnostic assay development but also a valuable tool for applications in many other medical settings. Care centers and hospitals that collect a vast amount of information on its patients can utilize effective ways to store and retrieve their data for reporting and communication as well as for general trending and predictive analyses.

Data analysis requires combination of analytic techniques

Nuvera has developed a suite of analytical methodologies that include simple trending and graphical techniques as well as advanced techniques based on supervised or unsupervised algorithms for recognizing data patterns. These algorithms, developed since the founding of the Company, form the technology backbone of a capability to derive value from biological and medical data. The analytical suite has been successful in identifying and validating molecular traits related to endpoints such as therapy response, patient survival and general physical fitness and endurance.

Nuvera continues to employ its unique analytical capabilities to a variety of medical applications with care centers and hospitals for broader healthcare impact.

21st Century Diagnostics