Seracare Life Sciences, Inc. | Date: 2015-12-28
Chemical reagents for non-medical purposes; diagnostic chemicals, reagents, or preparations for scientific, research, clinical or medical laboratory use.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 599.26K | Year: 2012
DESCRIPTION (provided by applicant): Rapid Test for Recent HIV Infection and Incidence Panels for Assay Evaluation Project Summary Accurate estimates of HIV incidence are required for monitoring the epidemic, for targeting resources, and for evaluating the effectiveness of various interventions. Yet the assays that underlie these estimates are widely understood to be flawed. Among the flaws are (1) the lack of consistent recency detection across HIV subtypes, (2) inconsistent availability of commercial test methods that have been modified to discriminate recent from long-standing infection, (3) difficulties to date in adapting incidence methods to test formats usable in resource-poor settings, and (4) lack of incidence panels (plasma samples from individuals with closely estimated infection dates) in sufficient volume for evaluation of multiple candidate assays. In this project, we propose to transform serological HIV incidence testing from the current ELISA methodology to a reliable lateral flow rapid testformat with good coverage of all HIV subtypes and a low false recency rate. The rapid test will be stable, multi-colored, fast, simple to use, and applicable to populations where varyin HIV subtypes are dominant. We also plan development of pedigreed incidence plasma panels for evaluation of this new test method; panels will be made commercially available worldwide. These products will be based on three key assets: a new highly sensitive rapid test technology based on a novel colorimetric detection system, which allows for analysis of antibody titer and avidity within a single cassette, to be applied for the first time to an incidence test for HIV; a ew HIV antigen (rIDR-M) which combines immunodominant sequences corresponding to all major subtypes; and aproven, IRB-approved protocol for identifying, recruiting, and retaining recently HIV infected individuals for blood collections to form incidence panels. The new colorimetric detection technology for rapid test yields bright, high-contrast, multicolor bands on a membrane. The sensitivity of this method far exceeds that of conventional colloidal gold or similar labels used in lateral flow rapid tests, as well as exceeding the sensitivity of comparable ELISA assays. The new rapid test method will be based on avidity and has been demonstrated to distinguish between incident and prevalent samples. The incidence panels to be generated concurrently will provide the essential tool with which to characterize the performance of the rapid test as well as other candidate incidence methods. In Phase I, we expect to complete development and validation of a prototype rapid test and establish six incidence serum panels. Additional panels, including multiple clades, will be collected in Phase II to support final development and characterization of a commercial version of the rapid HIV incidence test. PUBLIC HEALTH RELEVANCE: Rapid Test for Recent HIV Infection and Incidence Panels for Assay Evaluation Project Narrative SeraCare and Immunetics propose jointly to develop a new, rapid HIV incidence test for discrimination of recent vs. past infections by all HIV subtypes worldwide. Incidence/prevalence panels of well-characterized plasma from recently HIV infected individuals will be collected for use in qualifying this assay and will be made available commercially to other investigators and test developers. Development of a rapid and reliable test for recent HIV infection is a critical public health need for accurate determination of HIV incidence and will allow epidemiologists and researchers to understand whether HIV infection is increasing, decreasing, or staying level within a given population, greatly advancing the monitoring of interventions to reduce the spread of HIV worldwide.
Seracare Life Sciences, Inc. | Date: 2012-05-29
Diagnostic quality control and panel kits composed primarily of characterized sera for scientific or research use; diagnostic control and panel kits composed primarily of sera-based reagents for clinical or medical laboratory use.
Seracare Life Sciences, Inc. | Date: 2012-05-15
Cells and reagents for scientific, laboratory, or biomedical research; kits comprised of cells, reagents, and microplates for scientific, laboratory, or biomedical research.
News Article | April 6, 2015
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that Dennis Mulroy will join the Company as Chief Financial Officer, effective today. “Dennis brings to La Jolla over twenty years of financial management experience, including leadership positions in publicly traded biotechnology, life sciences, medical service and medical device companies,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “His impressive background and proven leadership skills will be an asset to the Company and a strong complement to our executive team.” “I’m excited to join the talented team at La Jolla as the Company prepares to advance its first product from late stage clinical development into commercial operations,” added Mr. Mulroy. Prior to joining La Jolla, Mr. Mulroy served as Chief Financial Officer of Taxus Cardium Pharmaceuticals Group Inc., a publicly traded biotechnology company, since 2005. Prior to joining Taxus Cardium, Mr. Mulroy served as Chief Financial Officer of Molecular Imaging, Inc. and SeraCare Life Sciences, Inc., and held financial management positions of increasing responsibility at several other companies. Mr. Mulroy began his career as a Certified Public Accountant with Ernst & Young LLP in San Diego and holds a degree in Business Administration, with an emphasis in Accounting, from the University of San Diego. La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has four product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. GCS-100 is La Jolla’s first-in-class galectin-3 inhibitor for the potential treatment of chronic kidney disease. LJPC-1010, La Jolla’s second-generation galectin-3 inhibitor, is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis and other diseases characterized by tissue fibrosis. LJPC-401 is La Jolla’s novel formulation of hepcidin for the potential treatment of conditions characterized by iron overload, such as hemochromatosis and beta thalassemia. For more information on La Jolla, please visit www.ljpc.com. Mr. Mulroy was awarded an option to purchase up to 60,000 shares of common stock on the commencement of his employment as an inducement to join the Company (Inducement Option). The Inducement Option, which has an exercise price equal to the fair value of the Company’s common stock on the date of grant, vests over a four-year period from the date of grant. The Inducement Option was granted outside of the Company’s shareholder-approved equity compensation plans, but will be governed in all respects as if granted under the Company’s 2013 Equity Incentive Plan. This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the Company’s future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to: the timing for the filing of an Investigational New Drug Application, commencement of clinical studies and the anticipated timing for completion of such studies; the success of future development activities for LJPC-501, GCS-100, LJPC-1010 and LJPC-401; and potential indications for which LJPC-501, GCS-100, LJPC-1010 and LJPC-401 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.
News Article | February 23, 2017
MILFORD, Mass., Feb. 23, 2017 /PRNewswire/ -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is announcing an upcoming four-part webinar series titled "Catalyzing Implementation of NGS-Based Tests" to be...
News Article | November 11, 2016
MILFORD, Mass., Nov. 11, 2016 /PRNewswire/ -- SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today at the Association for Molecular Pathology 2016 annual meeting the launch of two new reference materials for...
News Article | November 10, 2016
CHARLOTTE, N.C. and MILFORD, Mass., Nov. 10, 2016 /PRNewswire/ -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is announcing at the 2016 AMP Annual Meeting in Charlotte a collaboration with UK NEQAS, a...
News Article | February 21, 2017
MILFORD, Mass., Feb. 21, 2017 /PRNewswire/ -- SeraCare Life Sciences, Inc. announces the launch of Seraseq™ Fusion RNA Mix v2 and Seraseq FFPE Fusion RNA Reference Material v2. The two new products are based upon feedback from leading in vitro diagnostic assay developers of NGS-based RNA...