News Article | July 18, 2017
Liquid biopsy, the non-invasive analysis of ctDNA, is poised to revolutionize cancer diagnostics and treatment. However, a major challenge for those developing and validating these assays is ensuring detection of rare pathogenic variants at very low allele frequencies. The advances in liquid biopsy technology have outpaced improvements in accompanying circulating cell-free DNA (cfDNA) QC materials and methods. Until now, the only options available have been remnant patient specimens or ultrasonicated cell lines. Unfortunately, remnant samples are notoriously difficult to source and are relatively poorly characterized. Ultrasonicated cell lines do not match native cfDNA in terms of size distribution and condition of the DNA, which leads to poor target enrichment, low library yield and complexity, and reduction in sensitivity for many assays. In order to overcome these challenges, SeraCare developed a unique patent-pending technology that produces a DNA fragment size-distribution which closely mimics native cfDNA, while decreasing DNA damage relative to ultrasonicated material. The result is a renewable source of highly characterized material that exhibits similar performance when treated identically to a patient sample. Unlike ultrasonicated materials, for which increased DNA input amount or sequencing depth must be used to obtain similar performance, the Seraseq ctDNA v2 requires no special workflow considerations to generate informative data. This is especially important for validation studies that require strict adherence to standard operating procedures. This unique product contains 40 somatic mutations, including the most important alterations for ctDNA analysis such as BRAF V600E, KRAS G12D, and EGFR T790M and an EGFR exon 19 deletion. Variants are present against a single well-characterized genomic background across a range of allele frequencies down to 0.125%, which ensures utility for assays with different limits of detection. "One of the biggest challenges in developing highly sensitive ctDNA assays is the lack of reference materials that perform like real-world samples and contain all of the relevant variants. Seraseq ctDNA reference materials resemble native cfDNA, from pre-analytic assessment of DNA quality through sequencing. We expect these new references will greatly facilitate our assay development, and they also potentially will help our customers execute an effective QC strategy," said Dr. Jason Myers, CEO at ArcherDX. "Our longstanding relationship with SeraCare continues to result in products that fit previously unmet needs for next-generation liquid biopsy analysis." "As an industry leader for clinical genomics reference materials, we have spent significant time with subject experts to thoroughly understand the challenges ctDNA technologies face, and what is needed to effectively accelerate assay development and adoption in the clinic," said Russell Garlick, Ph.D., Chief Scientific Officer at SeraCare. "In response, we have developed a ground-breaking technology to produce highly functional, ctDNA-like materials, or truth sets, that will enable the industry to develop, optimize, and implement more accurate and robust assays. Our innovative Seraseq ctDNA reference materials can finally provide the assurances in variant composition and performance that labs are looking for, which have so far been elusive using existing methodologies and materials." Learn more about the patient-like characteristics of Seraseq ctDNA v2 reference materials at https://www.seracare.com/ctDNA. For data and in-depth technical information read this technical report: digital.seracare.com/ctDNA. SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only provide assurance of the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).
News Article | August 1, 2017
A major challenge in developing and validating a Zika assay is high cross-reactivity to other flaviviruses such as dengue and chikungunya, which are present in the same geographic regions as on-going Zika infections. To overcome this challenge, SeraCare has developed the AccuSet™ Zika Performance Panel, which is a comprehensive 10-member panel consisting of patient samples demonstrating a range of reactivity for Zika IgM antibodies, and assessed for cross-reactivity to dengue and chikungunya. This panel is intended for use by researchers, diagnostic manufacturers, and clinical laboratories to develop, evaluate, and validate Zika serological test methods. The panel members have been comprehensively tested following the recommended CDC algorithm and using several commercially available methods. This unprecedented panel of Zika IgM materials will ensure test method validation specific to Zika IgM reactivity and rule out cross-reactivity to related flaviviruses. Molecular assays for Zika virus detection are based on PCR methodologies. However, the options available for use as positive reference materials are limited to bacteriophage, RT-DNA (plasmids), and chemically treated, cultured virus. These alternatives either do not represent the full viral genome or are potentially infectious to handle. This is a concern when working within fertility laboratories where samples are of utmost value for use in fertilization techniques. To address these challenges, SeraCare has developed two new products: the AccuSpan™ Zika RNA Linearity Panel and the AccuPlex™ Zika RNA Reference Material, both formulated using our innovative AccuPlex recombinant virus technology. This technology offers a safe, non-replicative, non-infectious, and fully extractable positive reference material to support the development and evaluation of molecular diagnostics detecting the Zika virus. This fully packaged RNA virus closely resembles natural Zika virus genetically, containing the entire RNA genome of the ZIKV 2007 strain. The AccuSpan Zika Linearity Panel allows for assessment of the dynamic ranges of Zika PCR-based assays and the AccuPlex Zika RNA Reference Material, targeted to 1,000 copies/mL, serves as a positive reference material. These two products combined provide essential tools to validate and monitor Zika assays used for screening plasma, urine, and semen. Dr. Hisham Greiss, Director of the Fertility and Cryogenics Lab, located in Illinois, utilized the AccuPlex Zika materials to validate the Hologic Aptima® Zika Virus Assay for screening of semen samples. "I have very valuable samples in my fertility lab, therefore I chose the AccuPlex recombinant virus technology as a safer and suitable material to be used within my lab. I would not want the potential risk of exposure using a high titer Zika virus in a heat or chemically treated format. The AccuPlex recombinant virus was easy to use, performed as a patient sample, and supported the validation for my method." "The AccuPlex recombinant technology provides a valuable option to fast-track the development, validation, and implementation of molecular tests against pathogenic DNA or RNA viruses in multiple matrices," said Dr. Russell Garlick, CSO, SeraCare. "SeraCare is honored to collaborate with Dr. Greiss on this new application and delighted the AccuPlex Zika reference material performed to specification for screening semen samples." High specificity and sensitivity Zika diagnostic tests will enable clinicians to quickly and accurately diagnose Zika infection. Transmission of Zika Virus is primarily mosquito-borne, but sexual transmission has also been reported. Zika virus has been detected in semen up to 188 days post-infection and an infected mother has an increased risk of delivering babies with fetal microcephaly and other congenital brain abnormalities. Learn more about our comprehensive suite of our Zika products and see performance data by visiting https://digital.seracare.com/zika, or refer to the individual product pages: SeraCare is a leading partner and supplier of diagnostic quality controls, biological materials, and reagents to in vitro diagnostics developers, clinical laboratories, and life science researchers worldwide. Since the early 1980's, we have supported the diagnostic testing industry and have been a trusted source for providing biological materials to develop, validate and challenge today's serology and molecular infectious disease assays. Our portfolio includes a broad range of products such as quality control materials, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit https://www.seracare.com/ and follow SeraCare on Twitter (@SeraCare).
News Article | June 27, 2017
iQ NGS QC Management is the only software on the market that supports whole-workflow data capture from sample preparation to variant calling, along with the associated reagent and operator data, which are all critical to building a holistic depiction of the assay's performance. iQ NGS QC Management makes it easy for laboratories to re-create their QC workflows, set up their critical quality control metrics in the software, and have the data imported automatically using the new iQ Connector API: all to provide real time insights into performance. With the data recorded, lab managers can easily review and assess run performance, determine run pass or fail status, and identify potential sources of assay drift that may cause problems in future runs. The software then generates a Run QC Report that can be used for audits or inspections to demonstrate the run's performance in comparison to previous runs. Francine Blumental de Abreu, Assistant Director at the Laboratory for Clinical Genomics and Advanced Technology (CGAT) of Dartmouth-Hitchcock Medical Center, oversees the routine clinical use of NGS and has transitioned over from a bottleneck-generating, manual QC process to a streamlined, automated process. "iQ NGS QC Management has allowed us to track multiple QC metrics for each run, giving us new insights into how our assay is performing, and a higher level of confidence. It also makes it easy to demonstrate compliance and has reduced our audit preparation time," says Dr. de Abreu. "Our technologists are no longer spending hours manually tracking metrics on spreadsheets, and all the data we need to troubleshoot our assay is right at our fingertips." "The updates that we've made to iQ NGS QC Management further simplify QC data management and analysis for clinical genomics laboratories. The software now integrates with existing data systems like Illumina Basespace and LIMS, so from extraction to variant calling, all of the critical data are automatically populated," says Russell Garlick, PhD, SeraCare's CSO. "The greater functionality also enables labs to meet their QC signoff requirements for highly complex, multigene analysis with the quickest possible turnaround time." Additional information on SeraCare iQ NGS QC Management is available at: https://www.seracare.com/about-us/customers/precision-medicine/iq-NGS-QC-Management-software/ Learn more about Dr. de Abreu's story by watching her presentation here or reading the report: https://digital.seracare.com/automate-the-qc-data-analysis-of-your-clinical-ngs-test About SeraCare Life Sciences, Inc. SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only ensure the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare). To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/seracare-announces-qc-software-enhancements-for-higher-confidence-in-ngs-assay-performance-300479647.html
News Article | May 15, 2017
— Increasing health care awareness, growing investments on research & development, and introduction of innovative products are the factors propelling the market growth. In addition, growing proteomics research is bolstering the market growth. However, limited number of skilled professionals, high costs of products is the restrains hindering the market growth. Among all product segments, reagents is anticipated to dominate the market over the forecast period. This dominance is accounted for growing demand for peptide binding agents and increasing research and development activities. By application, immunological techniques segment represents largest segment with a higher market share. North America is anticipated to hold the largest share in global protein labeling market due to increasing demand from U.S. and Asia Pacific is likely to grow at a moderate rate during the forecast period. Some of the key players in global protein labeling market include Agilent Technologies Inc., Bio-Rad Laboratories, Eurogentec S.A, F. Hoffman-La Roche AG, General Electric Company, Kaneka Corporation, Kirkegaard & Perry Laboratories (KPL), Li-Cor, Inc., Merck KGaA (Germany), New England Biolabs, Perkinelmer, Inc., Promega Corporation, Qiagen N.V., Seracare Life Sciences, Inc., and Thermo Fisher Scientific, Inc. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 6 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements About Stratistics MRC We offer wide spectrum of research and consulting services with in-depth knowledge of different industries. We are known for customized research services, consulting services and Full Time Equivalent (FTE) services in the research world. We explore the market trends and draw our insights with valid assessments and analytical views. We use advanced techniques and tools among the quantitative and qualitative methodologies to identify the market trends. Our research reports and publications are routed to help our clients to design their business models and enhance their business growth in the competitive market scenario. We have a strong team with hand-picked consultants including project managers, implementers, industry experts, researchers, research evaluators and analysts with years of experience in delivering the complex projects. For more information, please visit http://www.strategymrc.com/
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.
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...