SomaLogic announces College of American Pathologists (CAP) accreditation of its CLIA laboratory

SomaLogic announces College of American Pathologists (CAP) accreditation of its CLIA laboratory


SomaLogic, Inc. announced today that its SomaLogic Clinical Laboratory (CLIA laboratory) has been registered with the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988, and has received accreditation by the College of American Pathologists (CAP).

“The CAP accreditation of our CLIA laboratory is an important milestone on our way to applying our unique proteomic technology to the transformation of research and clinical diagnostics,” said Byron Hewett, CEO of SomaLogic. “Through our CLIA laboratory, we will be able to provide a growing range of cutting-edge tests and assays across many different diseases for the academic and pharmaceutical research communities and, soon, for clinical providers and their patients.”
SomaLogic’s upcoming new SOMAmer reagent-based test offerings from its CLIA laboratory are based on novel protein biomarker combinations, or “signatures,” which have been discovered through the application of the company’s SOMAscan assay to a wide array of many different diseases and conditions.

SomaLogic’s CMS Registration Number is 06D2093281, and its CAP Accreditation Number is 7223571. SomaLogic is in full compliance with all provisions (including the Privacy and Security Rules) of the Health Insurance Portability and Accountability Act of 1996.

SomaLogic named “Company of the Year” at Colorado BioScience Association’s 2015 Awards Dinner

SomaLogic named “Company of the Year” at Colorado BioScience Association’s 2015 Awards Dinner


SomaLogic was recognized as “Company of the Year” by the Colorado BioScience Association (CBSA) at its 12th Annual Awards Dinner in Denver, CO, on November 12, 2015. SomaLogic was cited for developing “a new proteomics technology with a mission to leverage its proprietary technology to discover, develop and commercialize revolutionary new life science research tools and breakthrough clinical diagnostic products that will transform healthcare.” Chairman and Founder Larry Gold and CEO Byron Hewett accepted the award on behalf of the company.

CBSA represents more than 350 member organizations, including biotechnology, pharmaceutical, medical device, diagnostic, ag bio and mobile digital health companies, research and academic institutions and service providers.
For more information, please visit the CBSA website.

SomaLogic and Otsuka Pharmaceutical extend research collaboration for therapeutic SOMAmer development

SomaLogic and Otsuka Pharmaceutical extend research collaboration for therapeutic SOMAmer development


SomaLogic, Inc. announced today that Otsuka Pharmaceutical Co., Ltd. has extended its initial collaboration agreement with SomaLogic to continue the development of several SOMAmer® therapeutics. Specific projects and financial terms in the extended agreement were not disclosed.

“SOMAmer molecules are a promising new class of drug entities, and we are excited to continue our work with SomaLogic to fully realize that promise,” said Takayuki Shiratsuchi, Operating Officer and General Manager of Basic Research at Otsuka Pharmaceutical. “We are optimistic that extending this collaboration will help accelerate several of our ongoing therapeutics discovery and development efforts.”
SomaLogic is the recognized leader in the development and application of advanced aptamer technologies. The company has designed its proprietary SOMAmer (Slow Off-rate Modified Aptamer) reagents to combine the wide target range of antibodies with the consistency and reproducibility of traditional aptamers. The chemical addition of “protein-like” side chains to the nucleic acid bases that comprise a SOMAmer molecule results in the ability to discover molecules that bind specifically and tightly to virtually any targeted protein. These properties allow SOMAmer molecules to be used in virtually any laboratory or clinical application that currently uses monoclonal antibodies, including therapeutics. For example, SOMAmer molecules have been demonstrated to be potent inhibitors of specific targeted proteins. This property, along with other unique characteristics, makes SOMAmer candidates attractive for novel therapeutic discovery and development.

“We are delighted that our Otsuka colleagues see the value of our technology, and have chosen to extend their productive collaboration with us,” said Byron Hewett, CEO of SomaLogic. “The projects we are continuing to develop with them hold great potential for bringing novel therapeutics to the clinic for several unmet clinical needs.”

Large-scale discovery of Duchenne muscular dystrophy biomarkers published

Large-scale discovery of Duchenne muscular dystrophy biomarkers published


The results of a collaborative study by a large group of academic, industry and patient advocacy scientists to address the critical need for useful biomarkers to help with the diagnosis and treatment of Duchenne muscular dystrophy was published today in the Early Edition of the Proceedings of the National Academy of Sciences USA (PNAS). Using the SOMAscan assay to measure 1,125 proteins simultaneously in the blood of Duchenne patients and age-matched controls, the research group identified highly significant changes in the concentration levels of 44 different proteins. These findings are being shared openly with the entire Duchenne research and patient advocate community in the hope of driving further understanding of Duchenne biology, as well as accelerating new diagnostic and therapeutic development.

“Although we have known the genetic cause of Duchenne since the mid 1980s, progress towards effective treatments has been painfully slow, largely because we don’t have the biomarkers we need to quickly test promising new treatments or to provide a set of diagnostic and prognostic tests for each Duchenne patient,” said Pat Furlong, Founding President of Parent Project Muscular Dystrophy (PPMD) and an author of the PNAS study. “This work is an important and exciting step toward closing that gap.”

Using a new protein measurement technology from SomaLogic, blood samples from two different cohorts of Duchenne patients and non-Duchenne control volunteers (usually siblings of the Duchenne patients) were analyzed independently, and the results compared between the cohorts. Forty-four different proteins were found to be either highly increased (24 proteins) or decreased (20 proteins) in the Duchenne samples as compared to controls. While several of these protein changes have been previously described (usually related to the breakdown of muscle tissue and leakage into the blood stream), many of the other proteins discovered using this new approach were unexpected, and not previously associated with Duchenne. Furthermore, the majority of the protein concentrations observed varied widely with the age of the patient, and thus with the progressive severity of the disease.

“We are excited by the findings of this study, and are already pursuing some of the new leads that emerge from it,” said Yetrib Hathout, Associate Professor in the Department of Integrative Systems Biology, Center for Genetic Medicine at Children’s National Health System and first author on the PNAS paper. “These non-invasive biomarkers potentially can be used as readout to monitor disease progression and response to therapies in boys with Duchenne, and should also spur a large number of renewed efforts around finding new treatments for this devastating disease.”

The 1,125 proteins were measured using the “SOMAscan™ assay,” a technology developed by SomaLogic that can simultaneously and accurately measure the individual proteins in very small amounts of blood or other samples. By comparing patient and control samples, identification of critical differences in protein concentrations can be identified rapidly. These significantly different proteins can then be used as the basis for developing new diagnostic and therapeutic approaches, including their use as biomarkers for quickly assessing the efficacy of promising new drugs.

“This kind of study is precisely what we envisioned when we set out to discover and develop a new approach to protein measurement,” said Larry Gold, Founder and Chairman of SomaLogic and senior author on the PNAS paper. “We are thrilled to be a part of this important step towards improving the lives of Duchenne patients and their families, and look forward to expanding on these findings in collaboration with these and additional partners. We also hope that other researchers and advocacy groups will join forces with us to bring this powerful technology to bear on a wide range of rare diseases.”

About Duchenne muscular dystrophy

Duchenne muscular dystrophy is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3,500 to 5,000 live male births (about 20,000 new cases each year). Because the Duchenne gene is found on the X-chromosome, it primarily affects boys; however, it occurs across all races and cultures. Duchenne results in progressive loss of strength and is caused by a mutation in the gene that encodes for dystrophin. Because dystrophin is absent, the muscle cells are easily damaged. The progressive muscle weakness leads to serious medical problems, particularly issues relating to the heart and lungs. Young men with Duchenne typically live into their late twenties. Learn more at the PPMD website.

SomaLogic announces Novartis agreement extension, equity investment

SomaLogic announces Novartis agreement extension, equity investment


SomaLogic, Inc. announced today that Novartis has extended its multi-year research agreement for the development and application of SomaLogic’s unique proteomics technology to Novartis’ drug discovery and development efforts. Novartis will also take an equity position in SomaLogic under the agreement extension.

Under the previous collaboration agreement, scientists at the Novartis Institutes for BioMedical Research (NIBR) and SomaLogic worked together to build an enhanced proprietary version of SomaLogic’s SOMAscan™ proteomics assay for NIBR. The collaboration also included development of specific novel SOMAmer® (Slow Off-rate Modified Aptamer) binding reagents for multiple preclinical and clinical applications in NIBR’s research and development portfolio. The collaboration extension announced today will enhance and expand these efforts in addition to the equity investment in SomaLogic. Other specific terms of the agreement were not disclosed.

“Our ongoing relationship with Novartis is a model for how we seek to develop strong scientific collaborations that drive new discoveries and build value for both parties,” said Byron Hewett, Chief Executive Officer of SomaLogic. “We are delighted that Novartis has decided to continue our work together, and take it to an even higher level.”

Compared to other current proteomic technologies, SomaLogic’s offerings provide researchers with unprecedented power for protein biomarker discovery, diagnostics development, and pharmaceutical discovery and development. SOMAmer reagents, which are at the center of SomaLogic’s proteomics platform, are a new class of superior protein-binding reagents that combine the best properties of both monoclonal antibodies and traditional aptamers. They have wide applicability in many current preclinical and clinical analytical assays, including quantitative high-content screening, targeted panels, flow cytometry, histochemistry, functional assays, and biophysical methods. SomaLogic’s commercially available SOMAscan assay, which incorporates 1129 different SOMAmer reagents, can efficiently, accurately, and rapidly measure proteins across a wide range of concentrations in small volumes of multiple biological sample types.

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Children’s Hospital Colorado and SomaLogic Announce Collaboration to Develop Novel Diagnostic Tests

Children’s Hospital Colorado and SomaLogic Announce Collaboration to Develop Novel Diagnostic Tests


Children’s Hospital Colorado and SomaLogic, Inc. announced today that they have entered into a collaborative agreement to discover protein biomarkers and use those biomarkers to develop laboratory tests to improve the diagnosis and management of childhood diseases. The discovery and development work will be done using SomaLogic’s novel proteomics SOMAscan™ assay, which can measure more than a thousand proteins in a small amount of blood or other biological samples. This innovative collaboration is being entered into as a result of successful initial exploratory research done by the two organizations.

The research team will be led by Robin Deterding, M.D., Director of the Breathing Institute at Children’s Colorado, Professor of Pulmonary Medicine in the Department of Pediatrics at the University of Colorado School of Medicine, and Chair of the North American Children’s Interstitial and Diffuse Lung Disease Research Network (CHILDRN). Deterding is an international expert in the care of children with rare diffuse lung disease.

“We have a unique ‘game changing’ opportunity to rapidly discover and apply blood-based protein biomarkers for the early diagnosis of rare and common pediatric lung diseases, but also for the diagnosis, prognosis and monitoring of many other childhood diseases. ” said Dr. Deterding. “My colleagues and I are excited to continue our initial exploratory work with SomaLogic and their unprecedented protein measuring technology to find breakthrough new tools to dramatically improve the clinical care of children.”

Under the agreement, researchers at Children’s Colorado and SomaLogic will work together to widely analyze the proteins from blood samples obtained from children suffering from disease. They will then select those proteins, or biomarkers, whose change in concentration is correlated with disease (and its severity) to serve as a basis for developing in-house diagnostic tests for future clinical use. These tests will rely on SomaLogic’s technology, which can be scaled to measure from thousands of proteins for discovery of biomarkers to only a few selected proteins for diagnostic purposes.

“This collaboration with Children’s Hospital and CU School of Medicine faculty is the ideal model for how we would like to see our technology used by academic research centers to make a difference in the lives of patients,” said Byron Hewett, Chief Executive Officer of SomaLogic. “Their clinical insight and expertise matched to our proteomics expertise should lead to both a deeper understanding of the biology of these devastating diseases, and to new ways to manage them more precisely and effectively.”

“We are excited about the possibilities this partnership will develop for earlier identification and improved management of childhood diseases. SomaLogic’s innovative technology coupled with our clinical expertise will allow us to diagnose and ultimately improve treatment for children everywhere”, said Jim Shmerling, CEO of Children’s Hospital Colorado.

Financial details of the collaborative agreement were not disclosed.