BALTIMORE, MD, United States
BALTIMORE, MD, United States

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Patent
Biomarker Strategies | Date: 2013-03-27

Embodiments of the present invention are directed to improved methods and devices for analyzing a cell, aggregated cells, or a solid tumor. Such methods and devices are, for example, useful in the field of pathology and can provide improved cell processing and analytical results.


Patent
Biomarker Strategies | Date: 2015-08-20

Embodiments of the present invention are directed to improved methods and devices for analyzing a cell, aggregated cells, or a solid tumor. Such methods and devices are, for example, useful in the field of pathology and can provide improved cell processing and analytical results.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 299.88K | Year: 2015

DESCRIPTION provided by applicant Lung cancer LC is the leading cause of cancer death in the US with an estimated deaths in Non small cell LC is the predominant category of the disease NSCLC Molecular characterization of tumors has shifted the paradigm of one drug fits all Currently molecularly targeted agents MTAs and companion diagnostics CDx are being developed to target oncogenic drivers in signaling pathways and select patients most likely to respond respectively This personalized approach was successful in increasing response rates RR to erlotinib by enriching for patients with EGFR activating mutations RR versus in unselected patients Unfortunately within a year for most patients emergence of resistance mechanisms results in disease progression with little insight into appropriate follow up therapy In addition many patients have no clinicaly actionable biomarkers and are considered poor candidates for MTAs However many of these individuals can benefit from MTAs Five year survival rates are only in patients with distant metastatic disease when the disease is typically diagnosed Therefore there is an urgent medical need for improved predictive tests Here we propose to develop PathMAP r NSCLC an innovative CDx test to predict the optimal therapeutic approach for patients with advanced NSCLC This will be achieved by comparing the pharmacodynamic responses of signal transduction pathways upon exposure to four MTAs erlotinib crizotinib trametinib and sorafenib which target aberrantly activated proteins in these pathways PathMAP NSCLC will be commerciality enabled using the SnapPath r Cancer Diagnostics System the first and only user friendly clinic ready method which automates and standardizes the interrogation of a patientandapos s live tumor cells Phase I Segment Specific Aim Optimize dispersion of NSCLC biopsies on the SnapPath instrument to prepare live cells for ex vivo modulation biopsies will be used to determine optimal SnapPath processing conditions Flow rates and total cycles will be varied to enable equal distribution to multiple testing chambers without perturbing signaling and cell death Specific Aim Evoke Functional Signaling Profiles in NSCLC clinical samples against erlotinib biopsies will be profiled using the SnapPath Process Milestones for transitioning to Phase II Effectively disperse and distribute clinical NSCLC biopsies on the SnapPath instrument Successfully generate functional profiles in andgt of the clinical samples Phase II Segment Specific Aim Optimize ex vivo conditions and response profile to predict sensitivity to MTAs NSCLC cell lines will be categorized into sensitive or resistant groups and functionally profiled to create the PathMAP NSCLC model Specific Aim Test predictive ex vivo cut off values using TumorGrafts and clinical NSCLC samples The PathMAP NSCLC model will be used to predict MTA efficacy in TumorGraft models and human clinical samples from patients with metastatic NSCLC These results are intended to be a proof of principle in humans PUBLIC HEALTH RELEVANCE Lung cancer is the leading cause of cancer related deaths worldwide and of all lung cancers are classified as NSCLC The overall goal of our proposal is to develop a companion diagnostic test to help clinicians predict the optimal therapeutic approach for patients with metastatic NSCLC The test will use an individualandapos s functional response to four highly prominent molecularly targeted agents MTAs


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 1.04M | Year: 2011

Fine Needle Aspiration Biopsy (FNAB) is a minimally-invasive method for sampling human tumors that is widely used in the United States. Historically, FNAB samples have provided adequate material for microscopic examination; however, the successful development and use of molecularly targeted agents (MTAs) against cancer will also demand the robust and reliable detection of novel molecular biomarkers in FNAB samples. One intriguing possibility is the identification of informative ex vivo biomarkers- dynamic biomarkers that can be elicited from live tumor cells obtained by FNAB. These ex vivo biomarkers have the potential to reveal the functional architecture of signaling pathways in individual tumors thus producing a molecular profile. We, and others, have successfully utilized FNAB samples for such studies using manual sample processing methods, but widespread application of this technique will require a robust and reproducible platform for implementation. In this contract proposal, we present an innovative FNA biopsy approach and instrument (SnapPath) that will uniquely address this unmet need. This proposal is extremely responsive to PHS 2009-1 (Topic 257), which expresses particular interest in "biopsy instruments and devices that preserve molecular profilesin tumors", including those that will "create an entirely new diagnostic area" and "enable individualized molecular therapy of solid tumors."


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 192.79K | Year: 2011

Most of the currently utilized predictive biomarkers for therapeutic decision-making provide information about the presence or absence of the drug target, but reveal little about the functional circuitry of the signaling network that the drug must also impact. Ex vivo biomarkers are dynamic molecular markers evoked from living tumor cells after removal from the patient. Such ex vivo biomarkers provide valuable mechanistic information that may facilitate drug development and guide the clinical selection of targeted therapeutics. We propose to develop a companion diagnostic test, named SnapMap, for drugs targeting the ErbB signal transduction network. This test will utilize tumor biopsy samples processed on the SnapPath tumor processing system to evoke ex vivo biomarkers from live tumor samples.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2013

Not Available


The present invention is based on the discovery that functional stratification and/or signaling profiles can be used for diagnosing disease status, determining drug resistance or sensitivity of cancer cells, monitoring a disease or responsiveness to a therapeutic agent, and/or predicting a therapeutic outcome for a subject. Provided herein are assays for diagnosis and/or prognosis of diseases in patients. Also provided are compositions and methods that evaluate the resistance or sensitivity of diseases to targeted therapeutic agents prior to initiation of the therapeutic regimen and to monitor the therapeutic effects of the therapeutic regimen. Also provided are methods for determining the difference between a basal level or state of a molecule in a sample and the level or state of the molecule after stimulation of a portion of the live sample with a modulator ex vivo, wherein the difference is expressed as a value which is indicative of the presence, absence or risk of having a disease. The methods of the invention may also be used for predicting the effect of an agent on the disease and monitoring the course of a subjects therapy.


Trademark
Biomarker Strategies | Date: 2012-11-20

Chemical reagents not for medical use, namely, peptide and nucleic acid based probes for use in laboratory analysis of biological fluids, cells and tissues. Clinical laboratory instruments for analysis of biological fluids, cells and tissues; laboratory plates, glass slides, tubes and chips for use in multi-well arrays for use in analysis of blood and other fluids. Medical device for collection and storage of biological fluids, cells or tissues for laboratory analysis. Scientific research for the development of new pharmaceutical products; custom design and development of chemical reagents and assay platforms for use in analysis of biological fluids, cells and tissues.


Trademark
Biomarker Strategies | Date: 2012-10-26

Assays and reagents for use in genetic research. Medical diagnostic assays for determining susceptibility of a subjects cancer to particular treatment regimens. Genetic testing services to enable development of pharmaceutical products and therapies.


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