Proteogenix is a corporation based in Portland, Oregon, United States, that develops and markets biomarker diagnostic tests for the detection of life-threatening pregnancy-related conditions. Proteogenix is currently developing non-invasive protein biomarker screening tests for intra-amniotic infection, premature birth, and Down syndrome, which combined cause 175,000 premature births each year in the United States alone. Wikipedia.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.40K | Year: 2004
DESCRIPTION (provided by applicant): We propose to develop new, efficient and reliable non-invasive methods for the diagnosis of chromosomal aneuplodies. At present, the definitive diagnosis of chromosomal aneuploidies follows a two-step process: mate
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 875.00K | Year: 2005
DESCRIPTION (provided by applicant): Safe and accurate diagnosis of chromosomal abnormalities is a major goal of prenatal screening. The assessment of aneuploidies such as trisomy 21 (Down's syndrome; DS) currently involves suggestive serum tests that are subsequently validated by invasive procedures such as amniocentesis or chorionic villus sampling. We have applied the tools of proteomic analysis to confirm the hypothesis that maternal serum markers for DS exist and can be used in the design of accurate and non-invasive tests. In our SBIR Phase-l studies, we identified specific differentially expressed protein biomarkers in maternal serum that were consistently characteristic of DS pregnancies. In this Phase-ll application, we propose to (1) verify the differential expression of the putative DS biomarker set in a larger cohort of DS and gestational age and sex-matched control samples derived from the FASTER NIH Trial database, and (2) develop a prototype MALDI-based high-throughput assay that will be validated in a blinded study employing the FASTER dataset supplemented with additional DS and control samples banked by ProeoGenix, Inc. The proposed studies extend our initial biodiscovery research and constitute the logical next step in the implementation of a proteomics-based analytical test that can be offered commercially, and which will replace current testing modalities.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.40K | Year: 2005
DESCRIPTION (provided by applicant): The frequency of neonatal sepsis has remained constant at between 1 and 5 per 1,000 live births in the United States for several years, resulting in approximately 8,000 neonates with early-onset sepsis annually. Due to the devastating consequences of the failure to diagnose and treat a neonate with sepsis, many infants undergo an evaluation for sepsis and the unnecessary administration of empiric antibiotics. Up to 600,000 neonates annually undergo an evaluation for sepsis during their birth hospitalization, and the diagnosis of "rule out sepsis" is the single most frequent discharge diagnosis from neonatal intensive care units. Traditionally, the diagnosis of suspected sepsis has been based upon clinical judgment, bacterial cultures, and adjunctive laboratory tests. Unfortunately, these adjunctive laboratory tests are insensitive, non-specific, and require 48 to 72 hours for the evaluation of bacterial cultures. Therefore, there is an urgent need for rapid and reliable tests for the diagnosis of neonatal sepsis. We hypothesize that there are neonatal serum proteins that are differentially expressed as a result of sepsis that could serve as diagnostic markers. Our proposed studies will employ state-of-the-art proteomics approaches to identify novel biomarkers of neonatal sepsis that can be used to develop a rapid point-of-service diagnostic test. To address our hypothesis, we propose the following specific aim: Specific aim 1. Identification of proteins that are differentially expressed in the cord blood of infants with sepsis. Cord blood from cases with confirmed neonatal sepsis and gestational age and birth weight-matched controls will be analyzed by (a) surface-enhanced laser desorption-ionization/time-of-flight (SELDI-TOF) mass spectrometry, (b) two-dimensional gel electrophoresis, and (c) isotope-coded affinity tagging (ICAT) to detect differentially expressed proteins. Candidate biomarkers will be subsequently identified by tandem mass spectrometry, and microsequence data will be used for antibody generation. Characterized antibodies will then be employed to verify differential expression by western immunoblotting. The proposed studies will provide the background data and reagents that will enable the subsequent design and implementation of a commercial diagnostic assay that will fulfill a critical need in neonatal medicine.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 106.36K | Year: 2006
DESCRIPTION (provided by applicant): Prostate cancer (CaP) is the most common malignancy in U.S. males, with over 300,000 new cases per year and almost 50,000 deaths per year. Identification of novel diagnostic markers and therapeutic targets for both incident and advanced CaP is a major goal of current research. First introduced in 1987, the serum level of prostate-specific antigen (PSA) remains the standard for non-invasive prostate cancer screening, with a level of 4.0 ng/ml being the currently accepted cut-off for referral for biopsy. A main source of concern with PSA measurements per se is the sensitivity of PSA assays versus their specificity, i.e., increased PSA levels that are due to factors other than prostate cancer, such as benign prostatic hyperplasia (BPH), prostatitis, etc. This is reflected by the fact that the ability of PSA to distinguish benign from malignant conditions is substantially better at concentrations above 10 ng/ml. Thus, the accurate characterization of cancer risk in patients in the so-called "gray zone" of 4-10 ng/ml requires an improved screening tool to prevent unnecessary diagnostic procedures. This need is reinforced by the presence of disseminated disease in 30% of men with PSA values in this range. An alternative approach would be the development of a multiplex assay that would measure a defined set of serum analytes that, together, would provide the basis for a robust algorithm for assessing CaP risk with single serum samples. We have initiated such an approach by identifying genes encoding secreted proteins that are uniquely up-regulated in CaP. We propose that the products of these genes will be present at elevated levels in the serum of men with CaP, and that these proteins represent a set of candidate biomarkers that can be exploited for the development of a sensitive and specific CaP screening tool. We will address this hypothesis in two specific aims. Aim 1 will determine the normal variation in an initial set of 20 candidate CaP biomarkers using antibody arrays and ELISA assays. Aim 2 will use a larger cohort that includes high-PSA, biopsy-positive and negative samples in an unblinded study to assess the efficacy of a smaller biomarker set to distinguish normals and biopsy- negative from CaP samples. These studies will provide the foundation for Phase-ll validation in a larger sample set and the identification of markers associated with disseminated, metastatic and androgen- independent disease, the improved diagnosis of which would also be of significant clinical utility.
ProteoGenix | Date: 2009-01-30
Diagnostic chemicals and reagents for in vitro scientific or research use; diagnostic assay test kits consisting of diagnostic chemicals and reagents for scientific or research use; antibody-based products, namely, antibodies for in vitro scientific or research use; bioassay test kits consisting primarily of in vitro reagents for scientific or research use in the diagnosis, monitoring or screening of conditions of physiological significance in the fields of obstetrics, gynecology, maternal and fetal medicine, and womens health; diagnostic preparations and reagents for clinical or medical laboratory use. Diagnostic chemicals and reagents for medical use; medical diagnostic reagents; bioassay reagents for medical purposes; bioassay reagents and kits comprised of bioassay reagents, chemicals and/or solutions for in vitro medical uses in obstetrics, gynecology, maternal and fetal medicine, and womens health; diagnostic test kits comprised of analytes used as markers or indicators for detecting diseases for in-vitro medical uses in obstetrics, gynecology, maternal and fetal medicine, and womens health. Medical diagnostic apparatus, instruments, systems, equipment and devices for use in the detection and diagnosis of diseases or medical conditions, namely, bioassay testing devices for detecting analytes used as markers or indicators for detecting diseases for in-vitro medical uses in obstetrics, gynecology, maternal and fetal medicine, and womens health.