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Covid Diagnostics, Pre-Term Birth Prediction, High-Plex Spatial Imaging Diagnostics; More

April 28, 2022 | New genomics efforts in Brazil, HPV variant tests, COVID-19 virus and antibody tests, pre-term birth prediction by RNA profiling, metabolomics-based diagnostics, high-plex spatial imaging, blood-based glycoproteomics, new device for detecting mild cognitive impairment, and an award for rapid infection diagnostics. 

BD launched a new family of fluorochrome reagents to improve data resolution compared to traditional fluorochromes, made possible by novel dye technology and artificial intelligence (AI) guidance. The launch of BD Horizon RealYellow 586 Reagents marks the first fluorochrome in a series from the new BD Horizon RealYellow and RealBlue Reagents product family. BD Horizon RealYellow and RealBlue Reagents were developed using novel BD dye technology and an AI-guided approach to selecting the optimal fluorochrome positions. The AI analyzed existing data from excitation and emission profiles of current commercially available fluorochromes, then identified the optimal positions in laser lines for new dyes to be developed. The BD Research and Development team then developed dyes to fit these profiles using a novel BD dye technology. This combination of next-generation dye technology and AI guidance makes the BD Horizon RealYellow and RealBlue Reagents the first of their kind. BD Horizon RealYellow 586 Reagents are now available globally online and through local sales representatives. Additional BD Horizon RealYellow and RealBlue Reagents will be made available soon. Press release.

Caris Life Sciences announced the opening of a new liquid biopsy laboratory in Phoenix, Arizona to further expand the company’s molecular profiling capabilities, which include tumor profiling and innovative blood-based cancer diagnostics. This $45 million investment in the company’s laboratory facilities will enable the company to continue to develop and launch its blood-based diagnostic assay, Caris Assure. Caris Assure sequences the complete coding region of a gene as well as all the RNAs being expressed. The opening of the new laboratory will create hundreds of new bioscience job opportunities in Phoenix. The state-of-the-art lab is one of the largest high-throughput sequencing facilities in the world and will provide profiling on blood specimens for up to 1,500 patients per day. Press release.

Seven Bridges announced a collaboration with the University of São Paulo (USP) and Google Cloud, as well as the Associação Genomas Brasil (Brazil Genome Association), to assist the DNA do Brasil (DNABr) project in building a reference genome that represents the genetic diversity of the Brazilian population. Currently, the human reference genome is based primarily on sequencing data acquired from people of European ancestry, making it challenging to identify and treat diseases in the Brazilian population whose genome is an admixture of Native Americans, Europeans, and sub-Saharan Africans. DNABr will use the Seven Bridges GRAF Suite to construct an accurate and representative genome graph reference to identify the genetic variations across this heterogeneous and admixed population. Google Cloud will provide significant computational and storage resources to process the vast amounts of whole genome sequencing data needed to build this ancestry-aware reference. The DNABr project, led by Lygia da Veiga Pereira, PhD, Tábita Hünemeier, PhD, Department of Genetics and Evolutionary Biology, Institute of Biosciences at USP, and Alexandre Pereira, PhD, Harvard Medical School, plans to sequence the genomes of 15,000 Brazilians utilizing blood samples from several longitudinal studies in the country. Press release.

Enzo Biochem received approval from the New York State Department of Health (DOH) for its AMPIPROBE HPV test, Enzo’s PCR-based test designed to detect 14 high-risk human papillomavirus (HPV) variants. HPV testing is part of Enzo’s focus on women’s health and oncology and leverages the company’s long history in HPV detection. Almost all cervical cancers are linked to infection with high-risk HPV, an extremely common virus transmitted through sexual contact. Press release.

Personalis announced the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal. The patent, US Patent No. 11,299,783, entitled “Methods and Systems for Genetic Analysis,” was issued on April 12, 2022. The patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD. They can also support tracking of variants specific to an individual patient’s cancer, such as those targeted by specific therapies or which are thought to elicit an immune response. Prespecified, tumor-naïve content can include variants not detected on initial sequencing of a tumor, but which may emerge and confer drug resistance as a tumor evolves. It can also include driver mutations of a second primary tumor, which may arise independently during the course of the initial cancer. The patent is a member of a family that broadly describes Personalis’ foundational work relating to the development of personalized assays for disease identification and tracking. Press release.

iSpecimen, a global online biospecimen marketplace that enables life scientists to search across a federated network of healthcare providers for biospecimens needed for medical research, announced that it added Acutis Diagnostics, a clinical diagnostics laboratory, to its platform as a laboratory services provider. Through the Acutis relationship, iSpecimen will now offer sequencing services to its research community that can help researchers better understand genetic mutations and their impact on diseases such as COVID-19 and cancer. Cancer and COVID-19 are currently the second and third leading causes of death in the U.S., respectively. As such, biospecimen samples for these diseases, along with corresponding sequencing data, remain in high demand among researchers who are working on the development of novel diagnostics and therapeutics that could lead to lifesaving medical interventions. By offering sequencing services for specimens procured on iSpecimen's platform, researchers can now identify desired samples and receive corresponding sequencing data from a single source instead of vetting and contracting with external sequencing service provider partners. Press release.

Mirvie, a pioneer in predicting unexpected pregnancy complications, announced the publication of a study in the American Journal of Obstetrics and Gynecology demonstrating that their RNA platform is the first to predict preterm birth by revealing the underlying biology of each pregnancy. The breakthrough research shows the platform can predict the condition months before symptoms occur and identify distinct biological pathways driving its development. The study analyzed tens of thousands of RNA messages from 242 ethnically diverse pregnant individuals using the Mirvie RNA platform. Specific RNA messages were able to predict preterm birth months before the occurrence of any symptoms. Importantly, the platform was able to identify distinct biological pathways likely driving the development of preterm birth, creating new options for therapeutic interventions. Press release.

Following a new investment of $6.1 million (NZD $8.8 million), biotech company Pictor announced a partnership with U.S. laboratory service provider Mobility Health, launching a new antibody test as an important advance in COVID-19 monitoring and treatment. The investment, led by former Morrison & Co CEO Marko Bogoievski and specialist growth investor K One W One Ltd. (K1W1), will support market and product development of the new antibody test and other Pictor in vitro diagnostics. This first of its kind test, Pictor’s PictArray SARS-CoV-2 assay, will enable high efficacy personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (spike protein (SP) and nucleocapsid protein (NP) antibodies) or from vaccination alone (SP antibodies only). It will also indicate whether at-risk patients have failed to mount a detectable antibody response despite vaccination or infection (SP and NP negative). Press release.

The Longitude Prize has announced the final phase in its mission to award £8 million ($10.5 million) to an affordable, accurate, and rapid diagnostic test to support treatment decisions, decrease the inappropriate use of antibiotics, and tackle the rising global pandemic of drug resistant infections. They announced that if the existing criteria of a time to result of 30 minutes is not met by September 2022, tests with a time to result of 60 minutes or less will be eligible. Current diagnostic testing for bacterial infections takes three days in a central laboratory. The Longitude Prize calls on innovators to develop new rapid tests that can be done at point-of-care. Innovative AMR diagnostic tests in low- and middle-income countries (LMICs) could save at least 333,000 lives a year. Press release.

Lifespin GmbH, a deep data company that is mapping human health and building an innovative health diagnostic testing platform based on metabolomics, announced that it has formally established a U.S. entity, Lifespin, Inc., incorporated in Delaware and based initially in Boston (MA), to accelerate the company’s access to U.S. healthcare market opportunities, clinical research partners, and investors. Lifespin is developing a groundbreaking diagnostic testing platform that utilizes Artificial Intelligence and Machine Learning to quantitatively identify variations in a person’s metabolism from the healthy baseline based on Lifespin’s proprietary database to help clinicians, for example, to diagnose diseases earlier. Lifespin combines biology, Deep Data, artificial intelligence and cloud technologies to enable digital metabolic insights for precision diagnostics including personalized disease management; precision drug monitoring for pharmaceutical, research and clinical settings; and precision nutrition for diabetes, obesity, diet and lifestyle interventions. The first commercial product in the regulated space will be software algorithms for health testing scalable via the cloud as Software-as-a-Service (SaaS). This is expected to launch in Europe later this year as a laboratory-developed test for clinical evaluation of Multiple Sclerosis, and later in the United States, followed by a test for Parkinson's Disease in 2023. Press release.

Venomtech is collaborating with Charles River Laboratories, International Inc. to help drug developers explore venom-derived compounds for a wide range of therapeutic targets. This newly formed collaboration will bring together Venomtech’s biology expertise and vast venom-derived peptide library with Charles River’s drug development and screening knowhow, providing pharmaceutical manufacturers with a one-stop service to explore this unique natural resource. Venomtech’s Targeted-Venom Discovery Array libraries provide researchers with a straightforward solution to rapidly screen thousands of individual venom fragments, with each array specifically designed to maximize hits for a specific target. Through the new collaboration, Charles River will be able to use this innovative resource—closely supported by Venomtech—to accelerate its clients’ pipelines, addressing difficult therapeutic targets, uncovering new mechanisms of action, and minimizing off-target effects. Press release.

Illumina announced the launch of its new state-of-the-art Solution Center in São Paulo, Brazil. The choice to bring the facility to Brazil reflects an increasing demand for and interest in clinical genomics, as well as Illumina's longstanding commitment to expanding global access to genomics in Latin America. Illumina's customers and partners in Brazil span basic research, applied markets, and, increasingly, clinical labs and healthcare institutions. The new Solution Center will enable Illumina to offer its partners an ideal environment for demonstrations and training sessions to optimize their education and experience with next-generation sequencing and array technologies. In addition, to help combat the pandemic in Brazil, Illumina partnered with the Ministry of Health to build a comprehensive public health network for tracking the spread of the virus. Throughout Brazil, 26 laboratories out of 28 use Illumina's sequencing systems. The 11,000 square-foot site features a fully operational lab equipped with cutting-edge Illumina technology to help train customers and partners throughout Brazil and Latin America. Press release.

Standard BioTools announced the launch of the Hyperion+ Imaging System, the new standard in high-plex spatial imaging, providing lower limits of detection as well as improved sample capacity and time to results. The Hyperion+ Imaging System provides researchers with a deep understanding of disease and response to treatment, with the ability to stratify subjects by linking high-plex data to outcomes in clinical studies. The system can process 100-plus samples per week, performing at twice the speed of the current Hyperion Imaging System, with a 1.6x lower limit of detection. This enables detection of dim markers, an advantage that can be critical for lower-expressing markers often used in translational studies. Results of a study using the Hyperion+ Imaging System to improve understanding of the biology and pathophysiology of the tumor microenvironment in pancreatic invasive ductal adenocarcinoma (PDAC) were presented in a poster session at the annual meeting of the American Association for Cancer Research (AACR) in New Orleans in April. Press release.

Ultrahuman announced the acquisition of consumer-focused wearable company LazyCo, creator of the Aina ring wearable. LazyCo will integrate with Ultrahuman’s global in-house hardware development team as they seek opportunities to enhance the user experience and help improve global metabolic health standards. Ultrahuman will leverage the LazyCo team’s expertise to generate deeper metabolic insights and better overall health insights for consumers. Press release.

Crosscope, a provider of AI-enabled digital pathology software, and Waleed Pharmacy & Stores an Omar Zawawi Establishment group company focused on bringing healthcare, hospital, and pharmaceutical solutions to Oman (officially the Sultanate of Oman), signed a Memorandum of Understanding to enable next-generation transformation in the Histopathology Landscape using the Crosscope AI-enabled digital pathology platform. Together they plan to bring state-of-the-art technological solutions to Oman enabling their commercialization to deliver comprehensive cancer care, thereby reducing the cancer burden in Oman. Along with this partnership, Waleed Pharmacy will be an official representative of Crosscope in the Oman region. Both the organizations intend to bring state-of-the-art comprehensive Digital Pathology Platform, AI, and ML tools for cancer diagnostic service providers. Press release.

Seegene, a molecular diagnostics company based in South Korea, announced that its Allplex RV Master Assay received approval from Australia's Therapeutic Goods Administration and achieved the European CE-IVD marking. Seegene's Allplex RV Master Assay can distinguish 21 targets for 19 different respiratory viruses, including COVID-19, flu, and common colds. Specifically, the assay can identify three genes of COVID-19, Flu A, Flu B, metapneumovirus, two types of respiratory syncytial virus, four types of parainfluenza virus, six types of adenovirus, and three types of human rhinovirus. Press release.

InterVenn Biosciences, an innovator in glycoproteomics, shared new data from glycoproteomic analysis on its perspectIV platform in poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans. In addition, Stanford professor Carolyn Bertozzi, Ph.D., an InterVenn co-founder, and Klaus Lindpaintner, MD, MPH, InterVenn Distinguished Scientist, shared insights during the InterVenn Exhibitor Spotlight Theater on April 10 on how glycoproteomics can advance translational research with the aim of helping to improve outcomes for cancer patients. InterVenn’s perspectIV platform is a novel, high-throughput analytical tool designed to interrogate the blood-based glycoproteome, extract new insights, and develop diagnostic solutions. It requires a significantly lower sample volume than most other analytical platforms and is not dependent on material shed by the tumor, allowing the detection of small, early stage, curable tumors that are commonly missed by other analytical methods. Press release.

PCR Biosystems has expanded its comprehensive range of diagnostic reagents with the launch of the Lyo-Ready Probe 1-Step Kit, a lyophilizable 4x RT-qPCR reagent mix designed for ultra-sensitive high-throughput detection of RNA sequences. The new reagents will bring the sensitivity of the company’s liquid format 1-step RT-qPCR reagents to a freeze-dryable format. As a result, simplified creation of freeze-dried multiplex assays with lower limits of detection will be possible, and the logistical and storage infrastructure required to deliver tests to the point of use will be streamlined. The lyo-ready kits contain a glycerol-free 4x qPCR mix, high-concentration thermostable UltraScript Reverse Transcriptase for superior sensitivity and accuracy, and a blend of excipients that confer identical performance pre- and post-drying. PCR Biosystems has been certified to conform to Quality Management System standard ISO 13485, ensuring full product traceability, and optimum lot-to-lot consistency. Press release.

Paige, a provider of clinical AI applications in pathology, received CE-IVD and UKCA marks for Paige Breast Lymph Node, their newly launched AI medical device software that helps pathologists detect whether breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review. With the CE-IVD and UKCA designations, laboratories and hospitals in the European Economic Area, Switzerland, and the UK can now use the product in the course of clinical diagnosis. Paige Breast Lymph Node uses the same underlying AI technology as Paige Prostate and can be deployed in any laboratory or hospital setting that is on the Paige Platform. Press release.

NuProbe, a global genomics and molecular diagnostics company, published data in Nature Communications describing the use of Quantitative Amplicon Sequencing (QASeq) to simultaneously detect copy number variations (CNVs) and mutations from the same sample. The results show detection of CNVs down to 5% heterozygous single copy gain or loss, and mutations down to 0.1% variant allele frequency (VAF), from both formalin-fixed, paraffin-embedded (FFPE) tissue samples and from cell-free DNA (cfDNA) samples. CNVs are an important class of DNA biomarkers for cancer. Depending on the exact type of cancer, CNVs can be present in up to 98% of patients and can influence therapy selection and prognosis prediction. CNVs are currently detected using fluorescence in situ hybridization (FISH) or digital droplet PCR (ddPCR). However, these methods are limited in their multiplexing, and typically no more than about 4 genes can be profiled for CNVs with these methods. Furthermore, these methods cannot be used for profiling DNA mutations from the same samples. Consequently, comprehensive DNA profiling of many genes would require larger input quantities of patient DNA, which are often not available. Press release.

ClearSky Medical Diagnostics has developed an intelligent medical device that can objectively diagnose mild cognitive impairment (MCI), a condition often suggested as an early stage of dementia. It is estimated that between five and 20 per cent of people aged over 65 have MCI, characterized by minor problems with cognition, such as memory or thinking. The prototype diagnostic device, MCI-Monitor, is worn by a patient while performing a “reach and grasp task”. The kinematic characteristics of reach-to-grasp actions and the visual attention while performing the task are captured by the MCI-Monitor and measured using AI-powered technology. ClearSky’s initial studies have suggested that MCI-Monitor is able to differentiate between Parkinson’s with normal cognition, PD-MCI (Parkinson’s Disease MCI), and PDD (Parkinson’s Disease Dementia). The company, which already has launched two CE-marked diagnostic and monitoring devices PD-Monitor and LID-Monitor, is now seeking partners to collaborate on the development and launch of MCI-Monitor to the general population. Press release.

Valo Health has acquired TARA Biosystems, a New York City-based cardiovascular disease biotechnology company, creating the first of its kind vertically integrated cardiovascular drug discovery and development platform. The combination of TARA's proprietary human three-dimensional tissue engineering and cardiac disease modeling capabilities with Valo's Opal Computational Platform positions Valo to transform cardiovascular disease drug discovery and development. TARA's state-of-the-art in vitro human cardiac disease models combined with Valo's artificial intelligence-driven Opal platform—which is built on high-fidelity patient data—creates a vertically integrated platform and a world-class cardiovascular disease franchise. Press release.

Imeka, the leading neuroimaging company combining diffusion imaging and AI to map white matter integrity, announced a collaboration with GE Healthcare to expand the capabilities of magnetic resonance imaging (MRI) and advance precision medicine for brain health. GE Healthcare will integrate Imeka’s non-invasive neuroimaging technology into the BrainWave advanced diffusion processing package to allow researchers and clinicians to analyze diffusion MRI signals in the brain in greater detail. GE Healthcare partners with Medical Numerics, Inc. to offer BrainWave, an easy-to-use analysis and visualization tool for functional brain image data. BrainWave enables processing, analysis, 3D rendering, and display of results from Blood Oxygen Level Dependent (BOLD) MRI and diffusion tractography scans. By leveraging Imeka’s advanced neuro imaging processing technology within BrainWave, researchers and clinicians will be able to quickly obtain highly localized views of white matter, which can yield valuable insights into the impact of central nervous system (CNS) diseases and disorders. Press release.

PathAI and GlaxoSmithKline (GSK) announced a strategic multi-year partnership to accelerate scientific research and drug development programs in oncology and non-alcoholic steatohepatitis (NASH) by leveraging PathAI’s technologies in digital pathology including the use of PathAI’s AIM-NASH tool. Press release.

KSL Diagnostics, Inc. has launched a first-of-its-kind antibody test that detects an individual’s immune response to COVID-19 and assesses the risk of infection if subsequently exposed. The COVID-19 Immune Index can help monitor effectiveness of COVID-19 virus protection through a simple blood test. This new assay correlates COVID-19 virus neutralization against a person’s antibody level, and it provides physicians and their patients an objective datapoint to help determine appropriate timing for booster vaccine doses and make informed decisions related to potential COVID-19 exposure. The test will be valuable for monitoring the immunity levels of nursing home and long-term care residents, veterans living in group housing, and patients undergoing treatment for cancer, organ transplants, or serious chronic illnesses, among others. KSL’s COVID-19 Immune Index is approved by New York State Department of Health/CLIA/Emergency Use Authorization (EUA). Press release.

Medidata announced that Labcorp has selected their technology platform to extend their 14-year partnership, the foundation of their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. Labcorp Drug Development has developed its offerings on Medidata technologies, starting with Rave EDC (electronic data capture), Coder, and TSDV (targeted source data verification). Labcorp is now also using most of the Medidata Clinical Cloud platform, including eCOA (electronic clinical outcome assessment), RTSM (randomization and trial supply management), and Imaging. Press release.

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