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New Diagnostic Partnerships, Products, and COVID-19 Testing Updates

June 29, 2021 | What’s next for Biogen and Eisai; COVID updates from Thermo Fisher, New England Biolabs, and OraSure; new products from QIAGEN, InterVenn, Nuvo Group and more.


The Luxembourg Institute of Health (LIH) announces the launch of CoLive Voice, a first-of-its kind digital health study that aims to advance the diagnosis, risk prediction and remote monitoring of various chronic conditions and symptoms by evaluating voice features. Leveraging breakthrough artificial intelligence approaches, the study will collect and analyse voice recordings in several languages from both the general population and people living with chronic or infectious diseases, to identify so-called ‘vocal biomarkers’. CoLive Voice is led by the Deep Digital Phenotyping research unit of the LIH Department of Population Health (DoPH) and is set to run for up to 10 years. Press release.

MicroGen Diagnostics has acquired its RTL Genomics partner lab to expand expertise and capacity in non-clinical primary research. For over a decade, RTL Genomics has focused on Next-Generation Sequencing, assay design, library preparation, bioinformatics and biostatistics for research purposes. Its client partners include government agencies and Fortune 500 businesses in all 50 states and 30 countries worldwide. Since 2008, MicroGenDX has been perfecting a mature bioinformatics pipeline for its targeted 16S and ITS NGS clinical testing, which has allowed the company to become the industry leader in highly accurate, rapid-turnaround, low-cost molecular diagnostics. The carefully curated MicroGenDX reference database now contains over 50,000 microbial species. With the addition of RTL Genomics lab resources and experienced staff, MicroGenDX and RTL Genomics aim to replicate the same bioinformatics success with whole genome sequencing. Press release.

Center for Diagnostic Imaging (CDI) is rebranding as RAYUS Radiology, a major milestone in the company’s 40-year history and indicator of its massive national growth and expansion plans. The evolution of RAYUS Radiology is the result of a multi-faceted transformation of the quality-first healthcare provider that began after Wellspring Capital Management acquired the business in March 2019. RAYUS has over 400 aligned radiologists, including subspecialists and sophisticated best-in-class technology throughout its nationwide network. The rollout of RAYUS Radiology will include a comprehensive rebrand across the United States, and the launch of the new “SHINE ON” marketing campaign, designed to challenge status quo in an industry where radiology is treated as an afterthought, not the first critical step in the diagnosis and proper treatment of disease.

Concert Genetics has released its comprehensive genetic test identification system for use in the market, enabling a level of automation in test ordering, coverage, payment and clinical decision support never before possible, the company announced. Concert’s Genetic Testing Units (GTUs) are the first and only ID system that uniquely identifies all 160,000 genetic testing products, organizes them into a multi-level taxonomy, and incorporates new tests as they enter the market, which is currently happening at a rate of more than 30 per day. Initially developed as an internal test tracking system, Concert’s GTUs have powered the company’s widely used, end-to-end genetic test management solutions. Press release.

Thermo Fisher Scientific has launched a new CE-IVD-marked COVID-19 test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's menu of highly accurate tests that detect active SARS-CoV-2 infections. The kit uses an advanced assay design which compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate. The TaqPath COVID-19 Fast PCR Combo Kit 2.0 test assesses raw saliva directly with a turnaround time of two hours to enable widespread, high-frequency testing. The first generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use a different assay design, respectively, received initial CE-IVD certification and Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in March 2020. Press release.

Early stage digital medicine company Cubismi has been selected to take part in the Microsoft for Startups global program as part of its efforts to propel critical-need interactive digital diagnostics into new standards of precision cancer care. Based in Wisconsin, Cubismi personalizes actionable visualizations and precision insights to transform and empower professional interactions and each patient’s journey. The Microsoft for Startups program provides access to leading technologies including Microsoft Azure, GitHub as well as mentorship and business support. The program will help to support Cubismi’s mission to transform the use of visual technology across healthcare, while addressing the current diagnostic error crisis caused by today’s legacy systems. Cubismi’s vision for its Emerge cloud platform, designed to address the existing pains associated with healthcare legacy systems, will come into fruition using Microsoft’s powerful cloud technology for rapid user interface interaction. Created by a team of multidisciplinary experts, the platform will leverage various forms of health data including medical imaging which represents 90% of the health data digital footprint, turning it into powerful, highly granular new insights about the human body.

QIAGEN has launched its QIAprep&amp CRISPR Kit and CRISPR Q-Primer Solutions that allow researchers to analyze edited genetic material with unparalleled speed and efficiency to determine how their interventions have changed the function of the DNA sequence in question. The new products add to the range of QIAGEN products that could also be used for CRISPR research such as the QIAGEN EndoFree Plasmid Kits and Plasmid Plus Kits. The QIAprep&amp CRISPR Kit and the new CRISPR Q-Primer Solutions provide scientists with a sensitive, all-in-one process for characterizing so-called knock-outs generated from guide RNA (gRNA) and knock-ins from small insertions during gene editing. Kit and solutions combine liquid-based sample preparation with downstream PCR detection as well as the Sanger method of DNA sequencing. Press release.

Avacta Group, the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, has entered into a non-exclusive distribution agreement with Calibre Scientific Inc., a global provider of life science products, for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test for professional use in the UK and European Economic Area (EEA). The non-exclusive distribution agreement for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test for professional use covers the UK and EEA. The test will be listed on Calibre’s web site and available to be purchased by professional users. Press release.

ClinSpec Diagnostics, the Glasgow-based developer of liquid biopsies for the early detection of cancer, has relaunched as Dxcover Limited. A spin-out from the University of Strathclyde, Dxcover aims to be a world leader in liquid biopsy and artificial intelligence for early detection of cancer and other diseases. Since spinout in 2019, the company has raised £5.1m in funding to date to progress its multi-cancer development program, now rebranded as the Dxcover Cancer Project. Investors in the technology include Scottish Enterprise, Mercia Asset Management, Norcliffe Capital, SIS Ventures, Eos Advisory and the University of Strathclyde. Following a period of growth and after reaching its round two funding target earlier this year, Dxcover is moving to new premises. It has taken on a 2000 sq ft lab and office space in the University’s Royal College Building in the heart of the Glasgow City Innovation District, home to many of the city’s fastest growing tech and science businesses. Press release.

New England Biolabs (NEB) has launched a web-based tool for monitoring the emergence of SARS-CoV-2 variants and their potential impact on COVID-19 diagnostic tests. The Primer Monitor Tool, which is updated regularly, provides simple visualization of known variants identified in the SARS-CoV-2 genome and offers insight into where commonly used or user-defined primer set assessment may be worthwhile. The U.S. Food and Drug Administration (FDA) issued guidance advising COVID-19 diagnostic developers to evaluate the impact of emerging and future SARS-CoV-2 variants on current diagnostic tests by routinely monitoring sequence alignment of primer/probe sequences with open access SARS-CoV-2 genomes databases such as GISAID, a global science initiative and primary source that provides open-access to genomic data of influenza viruses and the novel coronavirus responsible for COVID-19. The NEB tool comes pre-loaded with commonly used primer sequences from SARS-CoV-2 qPCR and LAMP assays and ARTIC sequencing workflows (currently v3). Users can monitor those predefined primer sets as well as upload their own sequences of interest, with the option to subscribe and be alerted should variation cross a specified threshold in a geographic region of interest. Press release.

InterVenn Biosciences has completed clinical and analytical validation in compliance with standards set by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) of GLORI, a liquid-biopsy diagnostic test capable of differentiating between malignant and benign female pelvic tumors. This test marks a significant milestone for InterVenn as it seeks to establish its proprietary mass-spectrometry-based, AI-powered technology as a scalable clinical platform capable of efficiently deploying glycoproteomic diagnostic tests for a range of indications. GLORI is a laboratory-developed test (LDT) that has been validated using both retrospective patient samples and samples collected prospectively in InterVenn’s ongoing VOCAL clinical trial. Development of GLORI was advanced after compelling positive results were obtained in an interim analysis of the VOCAL trial. With an overall accuracy of 86%, GLORI outperforms all other currently available blood-based tests used to manage patients with suspected ovarian cancer. Press release.

Copado has announced automated tools for configuration, deployment and integration of Veeva CRM, which will help customers drive digital transformation with speed, quality and value. Through the Veeva Technology Partner Program, Copado helps life sciences customers adopt proven DevOps tools, templates and best practices for seamless use with Veeva CRM, a leading multi-channel engagement solution built on the Salesforce platform. This enables DevOps teams to accelerate the delivery and security of Veeva CRM applications and features. This partnership will enable Veeva CRM customers to move faster through their deployments. For example, the Copado platform helps companies migrate applications and features from a sandbox into production quickly with confidence, by providing guidance, testing, security and compliance. Press release.

Nuvo Group has received clearance from the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of uterine activity (UA). With this clearance, INVU can provide a reliable, passive alternative to existing methods of UA measurement. INVU uses only external sensors, allowing it to be used without any invasive component or the need for an in-hospital or in-clinic procedure. INVU’s UA module was tested extensively in a clinical study with 80 patients, in which the INVU UA was recorded simultaneously with and compared to the intrauterine pressure catheter (IUPC), the current gold standard of care. This clearance, which supplements INVU’s previous FDA clearance for remote monitoring of fetal and maternal heart rates (FHR and MHR), expands the clinical utility of the platform to enable antepartum fetal surveillance, such as non-stress tests (NSTs), to be performed non-invasively and remotely. Press release.

On the heels of the FDA approval of ADUHELMTM for treating Alzheimer's disease Biogen and Eisai Inc., U.S. subsidiary of Eisai Co., Ltd., have announced a range of programs intended to support access for all qualified patients, including traditionally underserved populations. These initiatives aim to help patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment. Personal Biogen Support Service Coordinators are now available to patients and their families to provide one-on-one support. The service coordinators can answer questions about Alzheimer's disease and ADUHELM treatment, assess financial assistance options for eligible patients, and locate healthcare providers and infusion sites, among other topics. Biogen and Eisai have also established a program with Labcorp and Mayo Clinic Laboratories to help physicians and patients access cerebrospinal fluid (CSF) diagnostic laboratory testing to aid in the diagnosis of Alzheimer's disease. Press release.

Thermo Fisher Scientific has introduced the Ion AmpliSeq SARS-CoV-2 Insight Research Assay to improve SARS-CoV-2 surveillance. The assay is designed to enable early identification of new and known variants from samples that have lower viral loads. The new Ion AmpliSeq SARS-CoV-2 Insight Research Assay broadens and improves local, regional, and national surveillance efforts to discover emerging SARS-CoV-2 variants through highly sensitive next-generation sequencing (NGS). Combined with Thermo Fisher's NGS technology, the panel enables researchers to obtain epidemiological insights with rapid turn-around time, workflow automation and seamless informatics and data uploading to public SARS-CoV-2 data repositories. Optimized to run on the Ion GeneStudio S5 System, the assay includes 237 amplicons specific to SARS-CoV-2, with the addition of variant-tolerant primers for emerging variants. The increased sensitivity of this assay will empower researchers to sequence the complete genome and discover new variants from a variety of sample types including nasophyrengeal and shallow nasal swabs, saliva and others, and with cycle threshold (Ct) values higher than 28, or as low as 50 viral copies. Press release.

OraSure Technologies has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which the Company is branding as InteliSwab. These tests detect active COVID-19 infection. The FDA has authorized the InteliSwab COVID-19 Rapid Test for Over-the-Counter use without a prescription. FDA has also authorized the InteliSwab COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab COVID-19 Rapid Test Rx for Prescription Home Use. The unique design of InteliSwab incorporates a built-in swab that is fully integrated into the test stick, simplifying the entire testing process. Using InteliSwab to test for COVID-19 requires less than one minute of “hands-on” time. Press release.

Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an Interdisciplinary Research Group (IRG) at the Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, have developed a new method for rapid and accurate detection of viral nucleic acids. The new methodological development by CAMP—the RApid DIgital Crispr Approach (RADICA)—allows absolute quantification of viral nucleic acids in 40-60 minutes in an isothermal manner in a water bath, a prototypical and inexpensive laboratory equipment. The team’s research is explained in a paper titled “Digital CRISPR-based method for the rapid detection and absolute quantification of nucleic acids” published recently in Biomaterials. Press release.