Phenomix Sciences | May 27, 2022
Phenomix Sciences (Phenomix), a precision biotechnology company bringing data intelligence to the treatment of obesity, announces today the launch of its biobanking registry and outcome study. The registry will study variability in obesity by looking at patients' DNA, metabolomics, hormones, patient behavior, assessments, and treatment outcomes. The data collected will supplement the 20 billion unique data points that make up the Phenomix Sciences Obesity Platform. Mayo Clinic is the first to enroll in the registry with its Rochester site set to contribute patient outcomes from 2,000 patients undergoing treatment for obesity to its biobank.
The biobanking registry is a critical milestone in Phenomix's mission to conquer obesity by creating unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Outcomes data generated from the biobanks across the registry will supplement Phenomix's database of biological and clinical data matched to the four obesity phenotypes. Insights generated from the database are being used to develop more predictive tests to identify the right intervention for each patient with obesity. This will allow for a better understanding of variability in patient outcomes when undergoing obesity treatments. Despite the justifiable excitement about new weight management products such as semaglutide and tirzepatide, several clinical studies from Phenomix's founders indicate that patient response varies with underlying phenotype. Thus, for many patients, it will open the door to the most effective and appropriate intervention for their unique phenotype.
A growing body of evidence indicates that obesity is not a single disease with a single treatment type, but a constellation of diseases. Obesity's roots lie in individual DNA; however, evidence suggests there is a complicated web connecting obesity to age, race, and gender, education, and socioeconomic status. Understanding a person's obesity phenotype — the combination of genes with environmental and behavioral factors — can help pinpoint the cause of weight gain. Phenomix's phenotypes are based on research from its physician founders, Andres Acosta, MD, PhD and Michael Camilleri, MD of Mayo Clinic, that has demonstrated when patients have been phenotyped and prescribed the right medications, they can achieve up to 16 percent total body weight loss (TBWL).
In addition to creating the first biobanking registry of this type, this is the first large scale study to monitor phenotypes in patients with obesity being treated with a variety of treatments. The impact of this biobanking registry and the data it will yield has the potential to change the entire system's approach to obesity, from a treatment recommendation to the way payers determine coverage and how industry combines diagnostics testing with drug therapy.
This unique biobanking registry will provide critical and contemporary data on obesity outcomes, impacting every stakeholder in the episode of care, This registry is an important opportunity to make vast strides in how we understand the complexities of obesity treatment. All obesity programs should be seeking the opportunity to participate and contribute to this registry. The more data we have on the variables that contribute to an individual's obesity diagnosis, the more lives we can save by putting the best treatment plan forward. We believe the investment in the biobanking registry will better support obesity centers by providing concrete evidence and insight into how DNA and other factors need to be considered in treatment. Patients can benefit greatly from achieving the desired outcome the first time around, and payers avoid paying for trial-and-error approaches and can reduce overall co-morbid conditions for members."
Mark Bagnall, CEO of Phenomix Sciences.
About Phenomix Sciences
Phenomix Sciences is a biotechnology pioneer on a mission to conquer obesity globally through the science of phenotyping, the understanding of how genes combined with environmental and behavioral factors can inform obesity treatment plans. Mayo Clinic physicians, scientists, and researchers, Andres Acosta, MD, and Michael Camilleri, MD, founded the company under the belief that the key to understanding obesity is unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Phenomix leverages data intelligence for yielding better accuracy in predicting individual patient response to specific weight loss interventions and reducing the variability in weight loss results for patients.
Meridian | June 21, 2022
Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today two new sample-specific master mixes, Lyo-Ready™ Direct DNA qPCR Stool Mix, and Lyo-Ready™ Direct RNA/DNA qPCR Stool Mix. These innovative master mixes improve the molecular detection of DNA and RNA from crude fecal specimens while allowing room temperature stabilization of diagnostic assays.
Stool samples are used in many gastrointestinal diagnostic tests to screen for harmful bacteria, fungi, viruses, autoimmune conditions, and colorectal cancer (CRC). The fecal occult blood test (FOBT) has been the most widely used gastrointestinal immunoassay to screen CRC for over three decades. However, recent large-scale studies have shown that the FOBT lacks the sensitivity to detect early stages of CRC. Better diagnostic tools are needed to improve assay accuracy, sensitivity, and affordability. Molecular testing is the newest alternative and offers significant improvement in sensitivity and accuracy, especially when multiple targets are detected in the results of a multiplex test. Detection of DNA or RNA from stool is challenging because it contains an array of PCR inhibitors including bile salts, polysaccharides, and catabolic substances. To overcome these challenges, assays typically require expensive and time-consuming sample processing and extraction steps which increase the time to results and cost – ultimately delaying physician diagnosis and patient treatment.
Meridian's new Lyo-Ready™ Direct DNA qPCR Stool and Lyo-Ready™ Direct RNA/DNA qPCR Stool Mixes remove the need for time-consuming nucleic acid extraction or lengthy component optimization. This enables test developers to quickly develop faster and more sensitive assays for stool sample analysis. In addition, the mixes can be used in liquid or lyophilized format when ambient temperature assay stabilization is needed, removing the need for cold storage.
The use of Lyo-Ready™ Direct qPCR Stool mixes for DNA and RNA is ideal for cancer biomarker detection, early cancer detection, and cancer treatment monitoring where assay sensitivity can be lifesaving. The specific adaptation of our chemistries to stool specimens makes our master mixes the perfect tool for any developer seeking faster new product introduction, shorter time to results, or the ability to transform a wet assay to an ambient temperature-stable assay with minimum developmental time."
Florent Chang-Pi-Hin, Ph.D., Vice President of Research & Development - Life Science.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
CellCarta | May 23, 2022
CellCarta, a leading global provider of precision medicine laboratory services, announced today the acquisition of the commercial rights to the antibody panels and assays from Precision Assays, a leader in next-generation targeted proteomics testing solutions. A spin-off from Fred Hutchinson Cancer Center ("Fred Hutch"), Precision Assays develops and deploys high-end multiplex quantitative immuno-MRM mass spectrophotometry-based assays for its pharmaceutical and biotech industry clients.
The acquisition from Precision Assays of its large spectrum of targeted mass spectrometry assays characterized according to the National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) Tier 2 guidelines greatly expands CellCarta's capabilities in off-the-shelf multiplex protein quantification offerings ready for deployment in immuno-oncology clinical and pre-clinical studies.
Precision Assays' large portfolio of robust assays characterized according to CPTAC guidelines and its established proof of concept data will enable CellCarta to confidently support its clients' exploratory studies and therapeutic development strategies, offering them key solutions to address important clinical challenges and move their immuno-oncology programs forward. Given CellCarta's expertise in protein quantitation, these immuno-MRM panels can further be validated to support secondary and primary clinical endpoints."
Lorella Di Donato, Chief Operating Officer of CellCarta, Immunology and Proteomics Divisions.
Based on technology licensed from Fred Hutch, Precision Assays' platform is uniquely positioned to fully capture the unique advantages of multiplex protein quantification using targeted mass spectrometry. Founder Dr. Amanda Paulovich, a professor in the Clinical Research Division at Fred Hutch who holds the Aven Foundation Endowed Chair, is an internationally recognized pioneer in targeted mass spectrometry and a clinically trained oncologist. Dr. Paulovich has set best-in-class standards to support precision medicine studies in cancer-specific protein expression analysis in a variety of matrices from FFPE cancer tissue biopsies to clinical serum-based samples. Precision Assays is one of the few CROs to offer large and immuno-oncology relevant multiplex off-the-shelf panels and is at the forefront of targeted-mass spec proteomics-based research.
As a global CRO with expertise in targeted mass spectrometry and specializing in biomarker testing to support precision medicine, CellCarta is an ideal partner to deploy and industrialize our platform to support discovery, translational and clinical research, especially in precision medicine and immuno-oncology."
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 11 facilities located in Canada, USA, Belgium, Australia, and China.