DIAGNOSTICS

Meridian Launches New qPCR Master Mixes for Stool Samples to Accelerate Development of Molecular Assays

Meridian | June 21, 2022

Meridian_Launches_New
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.

Spotlight

One of the major challenges in biologic drug development is the need to characterize formulations of drug candidates. One significant bottleneck in this process is pH measurement of formulations. Measuring pH is ubiquitous in the laboratory and critical for preparing buffers, analyzing formulations, monitoring stability, and numerous other applications during formulation development.


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MEDICAL

Ratio Therapeutics Launches to Discover and Drive Early Clinical Development of Best-in-Class Targeted Radiopharmaceuticals for Treatment of Cancers

Ratio Therapeutics | June 13, 2022

Ratio Therapeutics Inc. today announced its launch with a mission to develop best-in-class targeted radiopharmaceuticals for the treatment of cancers. Founded by entrepreneurial scientists Jack Hoppin, Ph.D., and John Babich, Ph.D., Ratio emerges from stealth mode with more than $20 million in seed funding, fully funded development alliances with Bayer AG and Lantheus Holdings Inc., a robust portfolio of assets developed with two proprietary technologies, and a growing team of world-class experts in radiopharmaceuticals discovery and development. The company's near-term plans call for the submission of its first investigational new drug (IND) applications, which are expected this quarter, and the initiation of clinical trials later this year. Based in Boston, Ratio is set to move to a new 19,000-square-foot headquarters and research facility in the Seaport District in January. 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Ratio's scientists have already successfully incorporated Macropa into the Trillium platform as well as several peptides and antibodies. Macropa's unique chemistry enables ease of manufacture and robust in vitro and in vivo stability of the resulting radiotherapeutic compound. The ability to fine-tune our targeted radiotherapeutics using Trillium and Macropa enables us to address head-on the trifecta of typical challenges we see with most radiopharmaceuticals: delivery, safety and efficacy, Over the past year, we have generated significant preclinical data that demonstrate our ability to create excellent performing drug candidates that now are advancing into the clinic. Our goal is to become the partner of choice for pharmaceutical companies committed to this area of cancer therapy by enabling the optimization of a broad array of targeting compounds. We will shepherd these therapies through early clinical studies on our own or in collaboration." Dr. Babich, Ratio's President and Chief Scientific Officer. Targeted radiotherapy is an exciting and emerging field where chemistry meets physics meets medicine. We have assembled and will continue to build a world-class interdisciplinary team of researchers and developers with a singular focus on delivering these treatments to cancer patients. It isn't often that a start-up company has in place the early financial backing and industry support to advance entirely new drug discoveries to clinical development at this pace. It is with great pride that we announce our formal launch and exit from stealth mode." Dr. Hoppin, Ratio's Chairman and Chief Executive Officer. In collaboration with Bayer, Ratio has leveraged its Trillium platform for the identification of lead prostate-specific membrane antigen (PSMA)-targeted therapeutic compounds for prostate cancer. At the same time, Ratio is working with Lantheus to develop a lead fibroblast activation protein (FAP)-targeted PET diagnostic compound for a broad array of epithelial-derived cancers, such as breast, pancreatic, lung and stomach cancer. Both collaborations are fully funded and reflect the types of partnerships that Ratio is currently pursuing with other companies. About Ratio Therapeutics Ratio Therapeutics Inc. is a Boston-based pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. Founded by John Babich, Ph.D., and Jack Hoppin, Ph.D., the company currently employs a growing team of radiopharmaceuticals discovery and development experts with backgrounds in the life science industry. Ratio's fully integrated proprietary R&D platforms, Trillium™ and Macropa™, enable the imaging, discovery and advancement of novel radiopharmaceuticals that have first/best-in-class delivery, safety and efficacy properties. The tunable nature of the company's platforms enables the efficient and timely generation of numerous novel radiopharmaceuticals for a broad range of high unmet need in solid tumors. Built to be the radiopharmaceuticals discovery and development partner of choice, Ratio currently collaborates with Bayer and Lantheus.

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DIAGNOSTICS

Biodesix Announces Research Agreement with Top US Cancer Center

Biodesix | June 06, 2022

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement.” Scott Hutton, CEO, Biodesix. Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR™ platform, the Bio-Rad QX600™ ddPCR™ System. As part of Bio-Rad's continued growth in oncology and expansion into the field of molecular MRD monitoring, we are pleased that Biodesix is utilizing the advanced multiplexing QX600™ ddPCR™ System that will be launching later this year." Simon May, EVP & President, Life Science Group, Bio-Rad Laboratories. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19

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MEDICAL

Pfizer Completes Acquisition of ReViral

Pfizer | June 10, 2022

Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). ReViral brings to Pfizer a portfolio of promising therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell. Sisunatovir has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). It significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. A second program is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in this program is currently in phase 1 clinical development. We are excited to bring ReViral’s promising investigational treatments for RSV into our anti-infective pipeline at Pfizer. This acquisition further demonstrates our commitment to advancing pioneering science – both through our in-house expertise and our work with leading, innovative companies – with the goal of delivering new breakthroughs to patients suffering from serious infectious diseases, We believe these therapeutic candidates – and the scientific expertise that has advanced their development – will complement our ongoing work to help combat RSV infections, and we look forward to welcoming our new colleagues to further support these endeavors.” Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. RSV is a respiratory pathogen, which can lead to severe and life-threatening lower respiratory tract infections (LRTIs) in high-risk populations, including young children, immunocompromised individuals, and older adults. It is estimated to cause infections in approximately 64 million people, resulting in about 160,000 deaths, globally each year. Currently, treatment options for RSV are limited, with care management focused primarily on supportive measures for people with the illness. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

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INDUSTRIAL IMPACT

Persephone Biosciences Closes $15M Seed Financing Round

Persephone Biosciences | July 20, 2022

Persephone Biosciences Inc., a synthetic biology company reimagining patient and infant health through the development of microbiome-based medicines, today announced that it has closed a $15 million seed financing round. The round was co-led by First Bight Ventures and Propel Bio Partners, and included investments from Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, and ZhenFund among others. “This financing is a significant milestone for Persephone and the culmination of years of thoughtful engagement with forward-thinking investors and individuals who are committed to the vast potential of our platform and technology. We plan to deploy this capital to further expand our research and clinical programs across a range of therapeutic areas, as well as pursue new collaborations. With our ARGONAUT study ramping up, it is an exciting time for us. We are grateful for the support of all our stakeholders and their commitment and confidence in our vision.” Stephanie Culler, CEO and Co-founder of Persephone Biosciences Persephone was founded to leverage a unique understanding of the microbiome as a therapeutic approach for a number of indications, including infant health and oncology. The company’s ARGONAUT trial (NCT04638751) is the largest study ever conducted in the U.S. to identify biomarkers for cancer treatment and prevention by mapping the gut-immune axis. In December 2021, Persephone announced that Janssen Biotech, one of Janssen Pharmaceutical Companies of Johnson & Johnson, would collaborate with the company on the colorectal cancer patient arm of ARGONAUT, and on an arm of additional healthy individuals with varying cancer risk. Then in April 2022, Persephone announced a collaboration with Ginkgo Bioworks to enable the synthetic biology tools needed to develop the next generation of microbial therapies. About Persephone Biosciences Persephone Biosciences is pioneering the use of synthetic biology for the development of microbial products that impact patient and infant health. Persephone is building an end-to-end platform to industrialize the development of engineered cells that restore health to damaged human ecosystems. The company was founded in the summer of 2017 by synthetic and metabolic engineering pioneers, Stephanie Culler, Ph.D., and Steve Van Dien, Ph.D.

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Spotlight

One of the major challenges in biologic drug development is the need to characterize formulations of drug candidates. One significant bottleneck in this process is pH measurement of formulations. Measuring pH is ubiquitous in the laboratory and critical for preparing buffers, analyzing formulations, monitoring stability, and numerous other applications during formulation development.

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