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New COVID Diagnostics, Pandemic Sciences Centre Launches, New Products

June 1, 2021 | University of Oxford launches a new Pandemic Sciences Centre, Quest Diagnostics and Paige collaborate on AI for diagnostics, new products from Waters and Essenlix Corp, and COVID updates from Advanced Biological Laboratories, Ortho Clinical Diagnostics.


Soulbrain Holdings has acquired all controlling PixCell shares, as well as investing in the company, making Soulbrain the majority shareholder of PixCell Medical. The acquisition of PixCell aligns with Soulbrain's recent strategic transition into the healthcare and in vitro diagnostics space. Soulbrain, a leader in the semiconductor space, recently chose the bio-healthcare industry as an engine for growth and has already made several acquisitions and investments. PixCell Medical's flagship product, HemoScreen, is a point-of-care blood testing platform that can conduct blood cell analysis within five minutes by applying AI-driven novel microfluidic and lab-on-a-cartridge technology. FDA-cleared, CE-marked and TGA-approved, the HemoScreen reliably conducts five-part differential complete blood count (CBC) tests, producing results equivalent to laboratory analyzers in significantly less time. By applying a novel, patented microfluidics method called Viscoelastic Focusing to conduct the cell analysis, PixCell has miniaturized traditionally large and complex machinery. Soulbrain identified PixCell as a good fit for its strategy of entering the diagnostics and point-of-care testing space, with a purpose of distributing specialized diagnostic reagents and miniaturized medical devices. Press release.

SOPHiA GENETICS has released SOPHiA DDM for Blood Cancers, novel blood cancer testing solutions across the entire workflow from setup, genomic testing, and in-house advanced analytics. The solutions target the most relevant DNA variants and RNA fusion genes for blood cancers, and come with SOPHiA DDMTM platform analysis, easing the identification of major biomarkers with secondary and tertiary analyses. Molecular profiling by next-generation sequencing (NGS) of myeloid tumors has transformed the investigation of pathogenic variants that could cause blood cancers. However, difficulties such as NGS design optimization and implementing bioinformatics for accurate variant calling can still be challenging for new and existing laboratories. SOPHiA GENETICS’ scalable new portfolio is designed to address these challenges and empower labs to confidently and securely identify major biomarkers associated with different blood cancers. Press release.

Illumina and Next Generation Genomic Co., Ltd. (NGG Thailand) have announced the launch of VeriSeq NIPT Solution v2 in Thailand, a CE-IVD, next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT). The automated in-lab IVD solution will allow NGG Thailand to launch the Qualifi Prenatal Test and be the first laboratory in South East Asia to detect anomalies that targeted assays miss and deliver more insights into the health of a pregnancy compared to standard NIPT offerings. Using Illumina’s VeriSeq NIPT Solution v2, the test delivers a comprehensive view of the fetal genome compared to other CE-IVD NIPT products. NGG Thailand’s Qualifi Prenatal Test uses VeriSeq NIPT Solution v2 provides accurate information about fetal chromosomal status as early as 10 weeks of gestation using a single maternal blood draw. This noninvasive test provides a whole-genome sequencing (WGS) approach to NIPT, expanding prenatal screening beyond the three most common aneuploidies of chromosomes 21, 18 and 13, to all rare autosomal aneuploidies (RAAs), sex chromosome aneuploidies (SCAs), and large partial duplications and deletions. Press release.

QIAGEN has launched of an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit (therascreen KRAS Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN). The therascreen KRAS Kit is the first companion diagnostic test to obtain premarket approval from the U.S. Food and Drug Administration (FDA) for use to identify the KRAS G12C mutation in samples of NSCLC tumor tissue. KRAS is one of the most frequently occurring mutation in this form of cancer and is estimated to be present in up to 13% of cases of the disease. Until now KRAS G12C has not been actionable, and in fact had only previously been linked with resistance to therapies. The real-time qualitative PCR kit is used with the Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions and builds upon QIAGEN’s nine years of experience in KRAS CDx test development and commercialization. Press release.

The University of Oxford is launching of a new center of global research collaboration and excellence, the Pandemic Sciences Centre. The Centre’s mission will be to ensure that the world is better equipped to create global, and equitable science-driven solutions to prepare for, identify, and counter future pandemic threats. Within Oxford, the center will draw together academics and experts from across its research and innovation community, including from infectious diseases, vaccinology, immunology, structural biology, diagnostics, drug discovery, clinical trials, data science, public health, and social and political sciences. Nationally and internationally, the Centre will foster a multisectoral approach and invest in agile platforms and partnerships. The center will focus on three core themes: accelerating understanding and insights: generating actionable knowledge and data (from pathogens through to patients) in near 'real-time' and making this globally accessible; translating research into real-world solutions: creating and deploying effective, acceptable and equitable health technologies, including digital tools, diagnostics, treatments, and vaccines; and enhancing confidence, trust and impact:  identifying ways to strengthen societal and political engagement, resilience, and responsiveness. Press Release.

Thermo Fisher Scientific’s TaqPath COVID-19 CE-IVD RT PCR Kit has been independently validated as meeting the performance characteristics for the Day 2 and Day 8 COVID-19 quarantine protocol testing required for international travelers arriving in the United Kingdom. The United Kingdom has instituted quarantine rules for travelers entering the country that vary depending on the country of departure, but most people will be legally required to quarantine for ten days upon arrival. On days two and eight of their isolation, those travelers are obliged to take a PCR test to monitor for an active SARS-CoV-2 infection. Thermo Fisher’s TaqPath kit is now permitted to be used by laboratories and clinics in that surveillance. Press release.

Ibex Medical Analytics has announced CE Mark for the Galen Breast solution for use in supporting pathologists in detection of various types of breast cancer. The solution is now generally available as Ibex partners with laboratories, hospitals and health systems to implement artificial intelligence (AI) technology into the diagnostic workflow. Galen Breast has already been ordered by multiple labs, including a network-wide deployment at a leading pathology group in Europe. The CE Mark follows pioneering results from a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Galen Breast demonstrated very high accuracy in detecting various types of breast cancer, including invasive and in-situ cancers, distinguishing between different types of invasive cancer (e.g., lobular versus ductal carcinoma) and grading of DCIS lesions. These results validate the robustness of Galen Breast and support its adoption by pathology institutes that aim to improve their diagnostic accuracy by enhancing quality control with AI. Press release.

Quest Diagnostics and Paige have announced a collaboration designed to unlock the potential of artificial intelligence (AI) to improve and speed the diagnosis of cancer and other diseases that rely on pathologic assessment. The collaboration involves analysis using Paige's proprietary machine learning expertise of pathology diagnostic data and digitized slides from Quest Diagnostics and its AmeriPath and Dermpath businesses to uncover markers of cancer and other diseases. Using these insights, the parties intend to develop new software products which, following regulatory approval, will be marketed to pathologists, oncologists and other providers to support disease diagnosis. Near term, the parties also intend to license the insights to biopharmaceutical and research organizations to aid biomarker discovery, drug research and development and companion diagnostics. The collaboration will initially focus on solid tumor cancers, such as prostate, breast, colorectal and lung. The agreement involves shared revenue for achieving certain product and commercial milestones and, assuming regulatory approval, arrangements for Quest to use approved software products in its pathology operations as well as joint marketing and research. In addition, Quest's pathologists will aid in defining pathology workflows for using the products to support diagnostic decision-making. Additional terms were not disclosed. Press release.

Waters Corporation has introduced a new RUO LC-MS test method to advance critical infectious disease research. Waters SARS-CoV-2 LC-MS Kit (RUO) uses an orthogonal analytical method that directly detects and quantifies SARS-CoV-2 Nucleocapsid (NCAP) peptides that initial studies have shown to yield highly accurate, quantitative results. Waters has developed the SARS-CoV-2 LC-MS Kit (RUO) in support of a coalition of academic, commercial and government research scientists. This coalition worked to develop an alternative test method on LC-MS platforms in support of the United Kingdom’s National Health Service (NHS) Test & Trace program. Their goal was to create a complementary, high-throughput screening method that would also use different reagents to help relieve strain on the PCR reagent supply chain. In just 16 weeks, the research coalition went from development of the method in university labs to a translated LC-MS workflow – upon which the SARS-CoV-2 LC-MS Kit (RUO) is based. The Waters SARS-CoV-2 LC-MS Kit (RUO) has been optimized on the ACQUITY I-Class Plus System and the Xevo TQ-XS System. It comes in an adaptable automation-friendly format with liquid handling protocols for the Andrew+ Pipetting Robot on OneLab Software. Press release.

Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its DeepChek Whole Genome SARS-CoV-2 Genotyping Assay, the first in vitro diagnostics kit to aid clinical applications and intended for use on previously diagnosed COVID-19 patients. The kit provides multiplexed amplicons that can easily be prepared into distinct libraries or pooled with other types of samples and applications (Ex.: HIV, 16s RNA, Tuberculosis…) for subsequent Next Generation Sequencing on many platforms and lab configurations. It can be bundled with a downstream analysis software to perform a comprehensive list of clinically relevant analyses like SARS-CoV-2 variants identification (including UK, Indian, South African, Brazilian variants of concern databases like Pangolin and Nextclade) for cluster management. It is also used for nucleotide and amino-acid mutations calling and coupled with a constantly up-to-date knowledge database correlating genomic variations with clinical interpretations like virus infectivity or vaccine efficacy. All information is centralized into a PDF report. The analysis and listing of genomic variations by the analysis software, either through a Cloud access or local appliances, is for Research Use Only (RUO). Virologists and physicians use the related genotyping data in conjunction with other patients’ information. Press release.

The Alliance for Artificial Intelligence in Healthcare (AAIH) has announced the enrollment of multiple new members in Q1 2021, growing the organization to nearly 50 companies across the healthcare, life science, and technology industries. Signing on to support the advancement of AI in healthcare are Amicus Therapeutics, BioSig Technologies, CancerLinq, Celeris Therapeutics, Gain Therapeutics, Google, Hub Security, Lifebit, and Roche, joining founding members that include Recursion, Insilico Medicine, Valo and Janssen, the pharmaceutical companies of Johnson & Johnson. Founded in 2018, AAIH is the leading international advocacy organization for the responsible adoption and application of AI/ML technologies across the healthcare umbrella. By bringing together stakeholders from industry, government, academia, and finance, AAIH seeks to foster changes that result in the best outcomes for patients. Press release.

Ortho Clinical Diagnostics has launched the first quantitative COVID-19 IgG antibody test in addition to a total COVID-19 nucleocapsid antibody test. Ortho is the only company that offers laboratories in the U.S. a quantitative test in combination with a nucleocapsid test. Both tests help health care teams differentiate the cause of antibodies against SARS-CoV-2 and are processed on Ortho's VITROS Systems. Ortho's VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody test is the first antibody test available in the U.S. that provides numerical values calibrated to the World Health Organization (WHO) International Standard. Standardized quantitative antibody tests help align SARS-CoV-2 serological methods and allow for unified data comparison across laboratories. This uniform data is a first step toward understanding the rise and fall of antibodies in individuals and long-term impacts of the COVID-19 pandemic on communities and the overall population. Press release.

Also this month, Ortho Clinical Diagnostics launched enhanced ORTHO VISION Swift and ORTHO VISION Max Swift Analyzers. The new suite offers labs more processing power, enhanced responsiveness, and advanced data security to ensure results that are consistently fast, accurate, and reliable. Ortho’s ORTHO VISION Swift platform allows labs to optimize their resources by decreasing hands-on time, simplifying skill level requirements and streamlining operations. It automates over 99% of the daily workload, allowing labs to maintain throughput/turnaround time, consistently delivers dependable, on-time results regardless of menu complexity, automatically grades, interprets and accepts over 95% of tests, offers 50% quieter system operation and a 36% larger monitor to enhance workflow and results review, yields 24% less service calls when linked to e-Connectivity Technology, and increases performance due to an upgraded solid state drive and twice the processing and memory. Press release.

Essenlix Corporation, a developer, manufacturer, and provider of mobile instant health test solutions, is partnering with Roche Diagnostics Norway to implement Essenlix's iMOST platform for the Patient At-Home Test market. The Norwegian healthcare service is facing significant capacity challenges, with an increasing number of patients and elderly in need of health services, as well as a reduced supply of health personnel. To address these challenges and provide better healthcare, the Norwegian healthcare system is advancing into a new era of medical distance follow-up and treatment, which requires innovative technologies that allow patients to perform safe, accurate, reliable, and easy-to-use healthcare tests at home. Essenlix iMOST (instant Mobile Self Test) is a phone-based platform for personal, point-of-care, and clinical use. It is designed to allow anyone to perform a diagnostic test accurately, anywhere, anytime, using a single drop of body fluid and a smartphone, within about 60 seconds, at a low cost, with the result sent immediately to medical professionals. Press release.

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