RESEARCH TRIANGLE PARK, NC, United States
RESEARCH TRIANGLE PARK, NC, United States
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Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.40M | Year: 2015

DESCRIPTION provided by applicant Fine needle aspiration FNA cytology is the standard technique for evaluating thyroid nodules Hemorrhaging is common during the procedure however leading to an aspirate that is significantly diluted by blood Subsequent slide preparations are often suboptimal resulting in nondiagnostic outcomes that necessitate additional testing or diagnostic surgery In fact quality is so unpredictable that a pathologist must often be present in the operating room to certify that the slides are adequate thus adding substantial cost and complexity to the procedure Ancillary testing such as immunocytochemistry and fluorescence in situ hybridization can also be used for evaluating the aspirate but such tests are not usually carried out using smears due to a paucity of follicular cells and an abundance of red blood cells As a result additional slides must be prepared using expensive and time consuming techniques Thus there is a significant need for increasing the capture and isolation of thyroid cells on FNA slide preparations Affinergy is developing a novel technology for improving the quality of thyroid FNA slide preparations We have identified proprietary peptides that binds with high affinity to thyroid cells but not to red or white blood cells and we have developed a cell specific coating for glass slides that provides a simple reproducible method for preparing optimal FNA slides from samples contaminated with blood A reduction in non diagnostic results will lead to improved quality of care and fewer unnecessary tests and diagnostic surgeries At the conclusion of this Phase II project we will have sufficient data in hand to rapidly bring our peptide conjugated slides to market PUBLIC HEALTH RELEVANCE Thyroid fine needle aspiration cytology is challenging in aspirates contaminated by obscuring blood cells often leading to non diagnostic results A reduction in non diagnostic outcomes would lead to improved quality of care and a reduction in unnecessary procedures In this application we will develop a novel method for reliably separating thyroid cells and blood cells leading to higher quality slide preparations and fewer non diagnostic results


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 304.83K | Year: 2014

SUMMARY/ABSTRACT Fine-needle aspiration (FNA) cytology is the standard technique for evaluating thyroid nodules. Hemorrhaging is common during the procedure, however, leading to an aspirate that is diluted by blood. Subsequent slide preparations are oftensuboptimal, resulting in nondiagnostic outcomes that necessitate additional testing or diagnostic surgery. In fact, quality is so unpredictable that a pathologist must often be present in the operating room to certify that the slides are adequate, thus adding substantial cost and complexity to the procedure. Furthermore, even with an optimal slide preparation, cytology yields indeterminate results up to 30% of the time. In the absence of a conclusive diagnosis, most indeterminate patients are guided towardsan often unnecessary partial or near-total thyroidectomy. Immunocytochemistry and fluorescence in-situ hybridization are useful tools for diagnosing indeterminate cases, but such tests are not usually carried out on existing smears due to a paucity of fo


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 283.80K | Year: 2014

DESCRIPTION (provided by applicant): We will develop the first assay for multiplexed combinations of all 14 Bone Morphogenetic Proteins. Immunoassays are the gold standard for measuring proteins in clinical samples. However these antibody- based tests neither quantitate protein analyte variants, nor multiplex across large numbers of superfamily members. In addition, the availability of polyclonal and monoclonal antibodies is limited. We propose a novel solution to these problems, firstly by modifying a mass spectrometric immunocapture assay to use affinity capture-peptides to enrich clinically relevant protein variants. Secondly by exploitin the efficient and high- throughput production of synthetic peptides from phage display libraries as targeted capture-reagents. For proof-of-concept, we will develop a quantitative prototype assay for multiplexed combinations of all 14 Bone Morphogenetic Protein (BMP) members in human plasma. Phase II will validate multiplexed assays for the whole BMP/Transforming G


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 300.00K | Year: 2016

SUMMARY ABSTRACT Lung cancer is the leading cause of cancer related mortality in both men and women in United States with a dismal year survival rate of While surgery is the only curative option of the patients are diagnosed with inoperable advanced disease thus highlighting a lack of effective early screening methods Typically low dose computed tomography LDCT is used as the primary screening modality however of suspicious lung lesions identified by LDCT eventually are found to be benign As a result such patients undergo medically unnecessary procedures and treatments resulting in increased cost time and morbidity Hence there is an urgent need to develop a non invasive complementary screening technique which can identify the high risk population for lung cancer and thus enable detection of lung lesions at an early and potentially curable stage To this end cytological and molecular aberrations found in exfoliated bronchial epithelial cells in sputum of smokers have shown a strong correlation to lung cancer incidence However these diagnostically important cells represent less than of the cellular composition of sputum thus making their detection extremely challenging Hence it is essential to develop a method which can isolate and capture these scant yet important cells while removing the other obscuring cells from sputum and thereby improve the clinical utility of these vital biospecimens The goal of this Phase I application is to develop a novel peptide coated glass slide which can selectively capture and retain the epithelial cells of interest in a peptide modified region while moving the obscuring cells to a separate region of the slide Epithelial cell capture on the peptide modified slides will be first optimized to identify lead peptides for subsequent clinical testing Thereafter compatibility of the peptide modified slides with commonly employed clinical staining techniques will be established Finally the feasibility of using these peptide modified slides for capturing cells from human sputum specimens will be validated Successful completion of this project will not only allow for better visualization of the captured epithelial cells to the clinicians but also enable further downstream processing of these cells to identify molecular and or genetic atypia present because of the non destructive nature of this technology PROJECT NARRATIVE An overabundance of blood cells dilute the already scant epithelial cells of interest in sputum making diagnosis of lung malignancies extremely challenging and eventually resulting in additional invasive testing In this application we propose to develop a novel method for preparing optimal sputum smears and thereby maximize the clinical utility of these vital biospecimens for enabling downstream molecular analysis and ultimately preventing medically unnecessary procedures surgeries


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 300.00K | Year: 2016

SUMMARY ABSTRACT Preeclampsia is a complication of pregnancy characterized by elevated blood pressure proteinuria and endothelial dysfunction involving multiple organ systems Worldwide preeclampsia is the largest cause of fetal and maternal morbidity and mortality and accounts for nearly of maternal deaths in the United States alone each year Currently there is no approved diagnostic test to predict which patients will develop preeclampsia Patients with preeclampsia require hospitalization and continuous monitoring of the mother and fetus thus there is an urgent and unmet need for a diagnostic test that can identify those patients at risk for preeclampsia Preeclampsia is diagnosed when a patient s blood pressure measures mm Hg twice hours apart and either proteinuria or one of the following conditions is present thrombocytopenia renal insufficiency impaired liver function pulmonary edema or visual disturbances Significant efforts are underway to detect preeclampsia prior to disease onset Recently it was demonstrated that glomerular podocytes are shed into the urine of preeclamptic patients and can be visualized using podocyte specific antibodies Moreover shed podocytes can be detected in the second trimester prior to preeclampsia diagnosis with high sensitivity and specificity Methods to detect podocytes currently rely on overnight culture and sedimentation of cells onto collagen coated slides or Cytospin which is prone to high false positive rates due to contaminating red blood cells RBCs or casts Inconsistencies in the method of podocyte detection and lengthy overnight incubations susceptible to contamination weaken the utility of podocytes as a diagnostic marker of preeclampsia To this end Affinergy is developing a slide platform that can specifically capture and retain the diagnostic podocytes while moving the obscuring contaminants to a separate region of the slide Such a technology is amenable to downstream immunocytochemistry will improve the diagnostic quality of podocyte capture and lead to significant cost savings by minimizing time and need for expensive equipment In this Phase I application we will focus on developing optimal peptide modified slides for isolating podocyte visceral epithelial cells from urine to improve the diagnostic quality of clinical podocyte slide preparations PROJECT NARRATIVE Preeclampsia is a life threatening condition that affects nearly pregnant women in the United States and is only diagnosed after disease onset Recent research has shown that detection of podocytes shed in the urine in the second trimester is an accurate predictor of preeclampsia development later in pregnancy Affinergy is developing a novel method to detect podocytes from urine to improve detection and treatment of preeclampsia


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.11M | Year: 2014

DESCRIPTION provided by applicant Burn injuries and chronic wounds present a significant burden to patients and the US healthcare system Each year in the US there are burns that require medical treatment and burn patients that require hospitalization The mortality rate associated with severe burns can be as high as with of patient deaths arising from infection In addition to the risk of infection delays in burn wound closure prolong pain increase the chance of hypertrophic scarring or graft rejection and multiply the number of operative procedures Meanwhile venous ulcers occur in to US patients and of these patients will not respond to current treatments In addition to of patients with diabetes will suffer a chronic foot wound and up to of these wounds will eventually require amputation Stem cells can address the unmet needs in burn and wound therapy by accelerating the rate of vascularization and collagen deposition and by attenuating the inflammatory response Adipose derived mesenchymal stem cells ASCs and bone marrow derived mesenchymal stem cells BMSCs secrete a broad range of proteins that are crucial for neovascularization extracellular matrix ECM remodeling and the attenuation of an inflammatory response Multiple pre clinical and clinical reports suggest that ASCs and BMSCs improve healing of burn injuries and acute and chronic wounds However the use of expanded and cultured cells increases the time and cost of medical procedures and can delay treatment Therefore a product that can capture ASCs or BMSCs from autologous tissue at the point of care would have significant advantages over the use of cultured cells In this project we propose to develop a peptide coating for skin substitutes to capture and retain ASCs at the point of care When used to treat chronic wounds and severe burns the peptide coated skin substitute will accelerate vascularization and healing and provide substantially better outcomes for patients PUBLIC HEALTH RELEVANCE Adult stem cells provide numerous advantages to speed up the healing process of burn injuries and wounds In this application we propose to modify skin substitutes with a coating that will allow surgeons to capture adult stem cells onto the skin substitute during the operation Capturing adult stem cells at the point of care will reduce the costs associated with processing and expanding cells and delivery of autologous therapeutic cells will provide better and faster healing


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 293.82K | Year: 2015

DESCRIPTION provided by applicant Approximately Americans undergo regular dialysis treatment because of complete kidney failure otherwise known as end stage renal disease ESRD The number of patients afflicted with this condition increased six fold between and In ESRD patients serum concentrations of microglobulin m readily accumulate times higher than normal levels leading to the formation of m fibrils that deposit in the bone and joint space in a painful debilitating condition termed dialysis related amyloidosis DRA Current data indicates that depleting m from the circulation of ESRD patients reduces the severity of DRA symptoms Furthermore the amount of m removed is proportional to the extent of symptom improvement This suggests that removal of m from circulation is an effective strategy for treating DRA and that treatment efficacy would be maximized by removing as much m as possible To this end we will develop plasmapheresis columns that use small peptides to selectively deplete m from human plasma In the apheresis product we envision an automated and continuous in line circuit will be used to remove an ESRD patientsandapos blood which will then be separated into cell and plasma fractions The plasma fraction will flow through our m depletion column recombine with the patientandapos s blood cells and then be safely reintroduced into the body Current apheresis columns for treating DRA e g Lixelle approved in Japan but not available in the U S deplete m from blood This device depletes only of m from ESRD patients even when using the maximum safely allowable column size mL Moreover the column is non specific Lixelle depletes other proteins such as cytokines and also binds blood cells through non specific interactions with the column substrate This lack of specificity coupled with the columnandapos s large volume leads to significant adverse events such as hypotension and anemia that require many patients to halt treatment To remedy specificity concerns researchers have developed antibody based columns that can deplete m from plasma but these columns deplete even less m lower than Lixelle due to the large mass of antibodies We expect that depletion columns made with small peptides will be specific for m and bind up to fold more m than all existing techniques The specificity of peptide mediated m depletion from perfused plasma will drastically reduce side effects maximizing the benefits of this treatment for the largest number of patients Moreover mass scale production of peptides will be significantly less expensive than antibodies enhancing the commercialization potential of our device In this Phase application we will use phage display biopanning to identify small kD peptides that bind with high affinity and specificity to m These peptides will be grafted onto agarose substrates and used to capture m from human plasma Ultimately this technology will improve the quality of life for ESRD patients on long term dialysis PUBLIC HEALTH RELEVANCE Dialysis related amyloidosis DRA is a painful debilitating condition caused by excess microglobulin concentrations DRA affects a large portion of end stage renal disease patients undergoing dialysis Presently no treatments for this condition are available in the United States In Japan sorbent columns that deplete the microglobulin protein are available but current technologies bind low quantities of the protein or are non specific In this application we propose the development of peptide based sorbent columns that bind large quantities of microglobulin with high specificity


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 256.98K | Year: 2015

DESCRIPTION provided by applicant Severe Gram positive infections are difficult to treat and associated with high mortality in hospital settings Daptomycin is a broad spectrum antibiotic that has been successfully used to treat persisting Gram positive infections including skin and soft tissue infections right sided endocarditis and bacteremia Daptomycin is also highly effective against drug resistant strains such as methicillin resistant S aureus MRSA and vancomycin resistant enterococci VRE Current daptomycin dosing guidelines are derived from limited studies in healthy individuals where pharmacokinetics is highly predictable Unfortunately daptomycin pharmacokinetics are highly variable in the critically ill patients that typically receive the drug This leads to sub therapeutic dosing increased rates of treatment failure and recently the emergence of daptomycin resistant strains Therapeutic monitoring of daptomycin concentrations would thus enable clinicians to adjust doses in order to maintain an effective circulating concentration ultimately improving outcomes and preventing adverse effects Unfortunately there is no FDA approved test to measure daptomycin concentrations in a clinical setting Multiple clinical studies have concluded that current daptomycin dosing guidelines for critically ill and septic patients need to be reevaluated and adjusted and regular measurement of daptomycin levels in these patients are needed to ensure effective treatment To address this critical need Affinergy has begun development of an assay to measure circulating daptomycin concentrations We have identified a series of phage that bind with high affinity and specificity to daptomycin and we are developing an ELISA type assay using phage as a highly sensitive detection reagent At the conclusion of Phase we expect to have a technology that can be scaled up in Phase for use by clinicians and researchers to measure daptomycin concentrations in biological fluids PUBLIC HEALTH RELEVANCE Daptomycin is successfully used to treat severe Gram positive infections including methicillin resistant S aureus MRSA and vancomycin resistant enterococci VRE Current daptomycin dosing guidelines are derived from healthy patients However daptomycin pharmacokinetics is highly variable in critically ill patients and there are no FDA approved assays that can be used to therapeutically monitor daptomycin concentrations in the clinic In this application we propose to develop a novel phage based assay to facilitate measurement of daptomycin concentration in biological fluids


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 649.69K | Year: 2016

DESCRIPTION provided by applicant Severe Gram positive infections are difficult to treat and associated with high mortality in hospital settings Daptomycin is a broad spectrum antibiotic that has been successfully used to treat persisting Gram positive infections including skin and soft tissue infections right sided endocarditis and bacteremia Daptomycin is also highly effective against drug resistant strains such as methicillin resistant S aureus MRSA and vancomycin resistant enterococci VRE Current daptomycin dosing guidelines are derived from limited studies in healthy individuals where pharmacokinetics are highly predictable Unfortunately daptomycin pharmacokinetics are highly variable in the critically ill patients that typically receive the drug This leads to sub therapeutic dosing increased rates of treatment failure and in recent years the emergence of daptomycin resistant strains Therapeutic monitoring of daptomycin concentrations would thus enable clinicians to adjust doses in order to maintain an effective circulating concentration ultimately improving outcomes and preventing adverse effects Unfortunately there is no FDA approved test to measure daptomycin concentrations in a clinical setting Multiple clinical studies have concluded that current daptomycin dosing guidelines for critically ill and septic patients need to be reevaluated and adjusted and regular measurement of daptomycin levels in these patients are needed to ensure effective treatment To address this critical need Affinergy is developing a novel assay format using daptomycin binding phage to measure daptomycin concentrations in plasma At the conclusion of this Phase II project we will file a regulatory submission for FDA clearance of our assay PUBLIC HEALTH RELEVANCE Daptomycin is successfully used to treat severe Gram positive infections including methicillin resistant S aureus MRSA and vancomycin resistant enterococci VRE Current daptomycin dosing guidelines are derived from healthy patients However daptomycin pharmacokinetics are highly variable in critically ill patients and there are no FDA approved assays that can be used to therapeutically monitor daptomycin concentrations in the clinic In this application we propose to develop a novel phage based assay to facilitate measurement of daptomycin concentration in biological fluids


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 301.01K | Year: 2016

DESCRIPTION provided by applicant Endoscopic ultrasound guided fine needle aspiration biopsy is the standard technique for diagnosis and staging of suspicious pancreatic lesions Unfortunately blood and other unwanted debris are frequently present in these fine needle aspirates thus diluting and obscuring cells of interest Subsequent slide preparations from such aspirates are suboptimal leading to non diagnostic outcomes that necessitate repeat FNA biopsies and or additional procedures adding to both time and cost If the repeat testing remains inconclusive then the patients are guided towards surgical biopsies for diagnostic confirmation However surgery is not only expensive and morbid but may be contraindicated in most patients with advanced disease In such inoperable patients non surgical FNA samples are often the only cytological specimens available to the clinicians for diagnosis Hence there is a considerable need to develop a product that can improve the consistency and quality of FNA slide preparations as well as facilitate ancillary molecular testing on the slides To this end Affinergy has identified multiple high affinity peptides that specifically bind to pancreatic cells but not to red and white blood cells In this application we propose to develop peptide coated glass slides which will provide a simple and rapid method for preparing optimal pancreatic FNA slides for improved diagnostic outcomes At the conclusion of Phase I we expect to have established the feasibility of using our peptide modified slides for cytological analysis of pancreatic FNA specimens which can then be validated during Phase II utilizing clinical samples PUBLIC HEALTH RELEVANCE Diagnostic confirmation of pancreatic carcinomas is often challenging in pancreatic fine needle aspirates contaminated with blood and other debris In this proposal we will develop a novel method of improving visualization of slide preparations by specifically capturing diagnostic cells while removing obscuring contaminants

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