miniPCR bio Announces Launch of the GELATO™ an Integrated DNA Analysis System

miniPCR bio | September 09, 2020

miniPCR bio, a manufacturer of scientific tools for educators and researchers, today announced the launch of the GELATO™, an integrated DNA analysis system. GELATO™ combines gel electrophoresis with transillumination technology, allowing for simultaneous nucleic acid separation and visualization in a single, compact system. As a maker of innovative biotechnology for demanding settings, miniPCR bio has pioneered the development of tools that combine analytical power with the durability and affordability its broad range of users demand. "Our users were asking for a tool that integrates the capabilities of professional lab instruments with the ease of use and compact size of our educational tools," said Dr. Ezequiel Alvarez Saavedra, co-founder of miniPCR bio. "GELATO™ answers that call." Despite a small footprint, GELATO™'s range of casting options allows users to process up to 50 nucleic acid samples at a time. Its variable voltage built-in power supply allows for fast separation of DNA, and its integrated blue-light transilluminator makes it safe for use in all settings. GELATO™ includes a cell-phone compatible documentation hood and features a built-in cutting tray for direct gel excision.

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The unexpected lysis of a large culture of Halobacterium salinarum strain S9 was found to be caused by a novel myovirus, designated ChaoS9. Virus purification from the culture lysate revealed a homogeneous population of caudovirus-like particles.


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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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CELL AND GENE THERAPY

Dyadic Announces a NIIMBL Coronavirus Grant Under the White House’s American Rescue Plan

Dyadic International, Inc. | December 23, 2021

Dyadic International, Inc. a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, announced it is the recipient of one of thirty-two project grants awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals funded through the White House’s American Rescue Plan. Under the NIIMBL grant, Dyadic will receive up to $690,000 in funding to engineer the Company’s proprietary and patented C1 thermophilic fungal protein production platform to produce two different antibodies. “We are honored to have been selected by NIIMBL to receive this grant and to further leverage Dyadic’s C1-cell protein production platform to help the nation prevent, prepare for, and respond to coronavirus and other public health threats. The grant provides us with the opportunity, among other attributes, to further demonstrate to academia, industry, and governmental agencies the rapid speed at which we can develop stable C1 expressing cell lines to produce antibodies as compared to traditional cell lines, such as Chinese Hamster Ovary cells. We look forward to moving this project forward in the new year,” Mark Emalfarb, Dyadic’s President and Chief Executive Officer NIIMBL members include large and small companies, academic institutions, non-profits, and federal agency partners who are well-equipped to significantly strengthen the nation’s preparedness and response to public health crises. Through the ARP funding, NIIMBL has selected projects that will Provide testbeds for process development, for next generation manufacturing approaches, and for drug product manufacturing approaches that provide access to industrially relevant equipment and facilities for pre-competitive manufacturing innovation Support the development of significantly improved methods for vaccine production, quality, and distribution, including mRNA and other vaccine platforms Demonstrate rapid scaling for production of coronavirus antigens and medical countermeasures for variants of concern Train a diverse biopharmaceutical manufacturing workforce Demonstrate the concept of mobile Good Manufacturing Practices capabilities to support mRNA vaccine and gene therapy production Dyadic’s project grant is intended to benchmark the speed that the C1 manufacturing platform will have when compared to current state of the art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology in the U.S. Department of Commerce with significant additional support from its members. Visit NIIMBL.org to view a summary of these projects and to learn more about NIIMBL. About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica, named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.

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CELL AND GENE THERAPY

Exact Sciences Acquires PreventionGenetics to Accelerate Availability of Hereditary Cancer Testing for More Patients

Exact Sciences Corporation | January 10, 2022

Exact Sciences Corp. announced it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases. "PreventionGenetics is a natural fit with Exact Sciences, and we're thrilled to have their talented team join in our mission to make earlier cancer detection a routine part of medical care. We share in PreventionGenetics' belief that genetics can transform medicine, improve lives, and help eradicate cancer. With our deep relationships in primary care and PreventionGenetics' strong reputation among genetics specialists, Exact Sciences can help more people understand their inherited risk of cancer to catch it earlier and treat it more effectively." Kevin Conroy, Exact Sciences chairman and CEO Nearly 300,000 health care providers and more than 200 large U.S. health systems rely on Exact Sciences' Cologuard® and Oncotype DX® tests in primary care, women's health, oncology, and other specialties. In partnership with the PreventionGenetics team, Exact Sciences plans to leverage its unmatched commercial reach in diagnostics to expand hereditary cancer and genetic testing throughout the U.S. and globally. PreventionGenetics is a CLIA-certified and CAP-accredited clinical DNA testing laboratory, providing more than 5,000 predefined genetic tests for nearly all clinically relevant genes, additional custom panels, and comprehensive germline whole exome and whole genome sequencing tests. With a goal to improve lives through genetic testing, PreventionGenetics offers tests spanning decades of life including proactive health and wellness, cancer risk and screening, pediatric and adult-onset rare diseases, and others. These high-quality genetic tests are supported by deep sequencing capabilities and more than 100 peer-reviewed publications. Like Exact Sciences, the PreventionGenetics team is relentless in their pursuit of quality. This focus, combined with a best-in-class customer experience and turnaround times, has earned PreventionGenetics a strong reputation and brand recognition among genetics specialists and counselors. Transaction Terms Under the terms of the agreement, PreventionGenetics received total consideration of $190 million, comprised of 50% in Exact Sciences common stock and 50% in cash. PreventionGenetics expects preliminary, unaudited 2021 revenue of approximately $36 million and $3 million in adjusted EBITDA. XMS Capital served as financial advisor to Exact Sciences and K&L Gates served as its legal advisor. CrossTree Capital served as financial advisor to PreventionGenetics, and Winston & Strawn served as legal advisor. About PreventionGenetics Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome® and whole exome sequencing test, PGxome®. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer.

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MEDICAL

Cardea Bio completes planned launch of CRISPR QC

Cardea Bio | April 06, 2022

Today, Cardea Bio, Inc. - the world's only mass producer of biocompatible semiconductors - announced a significant milestone with the launch of CRISPR QC Inc. as a separate business using Cardea's CRISPR-chip™ technology for a range of quality control services for CRISPR gene editing. This milestone is an important move for Cardea Bio on its mission to realizing real-world applications of their BPU™ (Biosignal Processing Unit) Platform. After recently establishing dedicated lab facilities and office spaces, as well as completing the initial investor funding, CRISPR QC is now ready to offer analysis services for R&D groups in therapeutics, animal breeding, plant biology, and academics in need of advanced insights to their CRISPR efforts. One of the challenges for successful CRISPR gene editing is a lack of understanding and standardization of processes around predicting and optimizing CRISPR assay outcomes. At CRISPR QC, we work with scientists to improve the quality of life for all. That's why we're excited to work with the Chief Scientific Officer of Cardea Bio, Dr. Kiana Aran, who recently received NIH funding to help set some of the US quality control standards for CRISPR therapies, In addition to this, CRISPR QC provides previously unavailable data and insight into the CRISPR editing process, resulting in significant time-savings and first to market application opportunities for our customers, including CRISPR/Cas technology-driven solutions which are commercially available as of now." Ross Bundy, President of CRISPR QC. With CRISPR QC going into business with valuable first-of-a-kind services in the growing CRISPR space, we can now showcase a distinct example of what our BPU Platform can enable our partners to do - products and applications otherwise not possible. That in turn drives growth opportunities and revenue for Cardea Bio, unlocking significant value for both CRISPR QC's and Cardea's stakeholders, I'm anticipating that CRISPR QC will get a number of near-term opportunities to help its customers bring transformative gene-editing insights and solutions to scientists and researchers working on CRISPR therapies, as well as other market changing applications." Michael Heltzen, CEO at Cardea Bio. About CRISPR QC Inc. CRISPR QC is a biotechnology company dedicated to improving the capabilities of scientists and researchers to improve their CRISPR assay designs through technological innovation. Using market-leading solutions, we can identify CRISPR activity in amplicons and genomic DNA and model results of the CRISPR process In vivo vs. In vitro. Our service is available to therapeutic companies and academic researchers to help them accelerate the development of their CRISPR-based therapies and to animal breeding and plant biology scientists who seek to improve the food chain for humankind. About Cardea Bio Cardea Bio is the world's only mass producer of a biocompatible semiconductor, the BPU™ (Biosignal Processing Unit). The BPU is the first and only semiconductor capable of translating real-time streams of multiomics signals into digital information. Through the BPU™ platform, Cardea's long-term vision is to democratize access to the biosignals and insights behind the most advanced technology on our planet: Nature and biology. The Internet of Biology is that way becoming possible. Cardea is headquartered in San Diego and has additional activity in Los Angeles. Cardea is a 100% American developed and built biocompatible semiconductor technology for applications across a variety of sectors including human health, agriculture, molecular diagnostics, biotechnology, environmental monitoring, and animal health.

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