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NGS Solution Detects Aneuploidies, AI-Powered Biomarker Test for Urothelial Cancer

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A blood test detects T cells activated by Borrelia burgdorferi, the bacterium that causes Lyme disease; a new artificial intelligence model accurately identifies patients at increased risk of undiagnosed structural heart disease; newborn screening for sickle cell disease expands in sub-Saharan Africa; a new melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies; and more.

The Wyss Institute for Biologically Inspired Engineering at Harvard University and StataDX announced that the Wyss Institute’s affinity-based, multiplexed, electrochemical sensing technology, eRapid, has been licensed to the startup. The license, coordinated by Harvard’s Office of Technology Development, grants StataDX exclusive worldwide access to eRapid technology for neurological, cardiovascular, and renal diseases. The team will focus on developing diagnostic tests that address critical unmet diagnostic needs in various near-patient settings, such as physician offices, pharmacies, and eventually at home. The foundational discovery that started the development of eRapid was a novel antifouling nanocomposite coating that enables electrochemical electrodes to withstand the attack of biofouling molecules contained in various biofluids.

PerkinElmer is collaborating with Novartis to expand newborn screening for sickle cell disease (SCD) in sub-Saharan Africa. PerkinElmer and the Novartis Africa Sickle Cell Disease program aim to expand advocacy efforts to educate patients, caregivers, and communities about the importance of newborn screening and early intervention with hydroxyurea (HU) and other SCD treatments with hopes of reducing mortality in children under five by 94%. In addition, this collaboration hopes to galvanize governments to provide universal newborn screening as part of national health programs supporting early diagnosis and comprehensive interventions such as prophylactic penicillin, a pneumococcal vaccination, and therapies like HU.

Pictor, a biotech company, has received confirmation of CE registration for its PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay antibody test as per In Vitro Diagnostic Directive regulations. The CE Mark will allow the company to market its COVID-19 antibody test in Europe and gain regulatory approval in Southeast Asia. Pictor’s PictArray SARS-CoV-2 assay, the first test of its kind, will enable personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 from spike protein (SP) and nucleocapsid protein (NP) antibodies or vaccination alone (SP antibodies only). It will also indicate whether at-risk patients have failed to mount a detectable antibody response despite immunization or infection (SP and NP negative).

Adaptive Biotechnologies Corporation, a commercial-stage biotechnology company that translates the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced the launch of T-Detect Lyme. The T-Detect test detects an immune response by leveraging the body’s unique T-cell response to disease-associated antigens. T-Detect Lyme identifies T cells activated by Borrelia burgdorferi, the bacterium that causes Lyme disease, to help diagnose early Lyme disease. T-Detect Lyme, administered as a simple blood test, has a specificity of ~99% and showed more than 1.5 times greater sensitivity than standard two-tiered testing in patients who presented with a bullseye rash.

As part of its commitment to making next-generation sequencing (NGS) solutions available for clinical use, Thermo Fisher Scientific has received a CE-IVD In Vitro Diagnostic Medical Devices Directive (IVDD) Mark for its Ion Torrent Reporter Software Aneuploidy Dx Workflows. The workflows are registered for detecting aneuploidies like trisomy 21 under Annex II List B of the IVDD. The Ion Torrent Reporter Software Aneuploidy Dx Workflows provide a qualitative determination of aneuploidies, including trisomy status of chromosome 21, in genomic DNA derived from human cells using NGS. Aneuploidy detection is intended for screening embryos to improve in vitro fertilization outcomes.

Paige, a global company in clinical AI applications in pathology, is collaborating with Janssen Research & Development to evaluate the potential of a hematoxylin and eosin-based, artificial intelligence-powered biomarker test to predict the presence of specific, actionable alterations in the fibroblast growth factor receptor (FGFR) genes in patients with advanced urothelial cancer, also known as bladder cancer. This biomarker test, developed by Janssen, is a first-of-its-kind screening tool to predict the occurrence of actionable genomic alterations. The goal is to improve rates of confirmatory molecular testing and accelerate the recruitment of patients into biomarker-driven clinical trials that enroll patients with specific tumor FGFR mutations.

Inteleos, a non-profit global healthcare certification organization, is working to create partnerships in low-resource communities, where proficient use of ultrasound will improve maternal and fetal health and reduce mortality rates. By 2030, through the Inteleos Ultrasound Proficiency Grand Challenge initiative, every user of medical ultrasound in the world will be proficient and certified, ensuring patient safety and increasing equity in healthcare. The program aligns with the United Nations Sustainable Development Goal 3.1 to reduce the global maternal mortality ratio to less than 70 per 100,000 live births by 2030.

SomaLogic, a data-driven proteomics technology company, has signed a licensing agreement with OncoHost, a global next-generation precision oncology company for personalized cancer therapy. As part of the agreement, OncoHost will license SomaLogic’s SomaScan Platform to develop proteomics tests for its PROphet diagnostic system, designed to predict patient response to immunotherapy treatments and provide strategies to overcome treatment resistance. OncoHost will also use the SomaScan Platform to develop its laboratory-developed tests, allowing clinicians to make treatment decisions earlier in a patient’s disease progression and inform choices for alternative therapies. The SomaScan Platform is currently used in cancer research to study the changes in plasma protein levels in cancer patients.

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the Laboratory Corporation of America (LabCorp) VirSeq SARS-CoV-2 Next-Generation Sequencing (NGS) test on the PacBio Sequel II sequencing system. According to the FDA, the LabCorp VirSeq SARS-CoV-2 NGS Test is the first COVID-19 test to identify and differentiate SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak lineages. It is authorized for testing patient respiratory samples identified as SARS-CoV-2 positive using the LabCorp COVID-19 RT-PCR Test and LabCorp SARS-CoV-2 Influenza A/B Assay. The NGS test can be performed in laboratories designated by LabCorp that are certified under certain Clinical Laboratory Improvement Amendments, meeting requirements to perform high-complexity testing.

Foundation Medicine, a molecular cancer profiling company, received approval from the U.S. Food and Drug Administration for FoundationOne CDx as a companion diagnostic for the two indications of Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group. As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer or patients with Neurotrophic Tyrosine Receptor Kinase fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek.

GoMeyra, a cloud software company dedicated to providing innovative real-time software for the health care industry, launched a new telehealth platform–GoVirtual Clinic. This single-interface cloud-based solution allows labs, physicians, and nurses to administer medical tests and consult with patients over a secure remote platform. The first phase of the platform features ways to seamlessly schedule and manage virtual testing appointments, order test kits, monitor online waiting rooms, conduct virtual appointments, and share test results with patients in real-time.

Proscia’s Concentriq Dx platform was certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis. The IVDR certification demonstrates that Concentriq Dx complies with the more stringent quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. Concentriq Dx combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks.

Fisher Scientific announced an In Vitro Diagnostic Requirements (IVDR) version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to help molecular diagnostic manufacturers and clinical testing laboratories adapt to the higher-standard IVDR in effect in the European Union. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology. Furthermore, the qPCR system has an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes.

The University of Texas MD Anderson Cancer Center presented two studies that shed new light on the potential of the gut microbiome as a targetable biomarker to improve responses to immunotherapy. One study (DOI: 10.1200/JCO.2022.40.16_suppl.2006) reported gut microbiome associations with immunotherapy response in newly diagnosed glioblastoma patients. As a result, many clinical trials for glioblastoma at MD Anderson routinely include stool sample collection to enable correlative gut microbiome studies. The second study (DOI: 10.1200/JCO.2022.40.16_suppl.2511) identified a link between gut microbiome signatures, immune cells in the tumor microenvironment, and immune checkpoint blockade responses in melanoma, non-small cell lung cancer, and sarcoma.

Foundation Medicine, a molecular cancer profiling company, collaborated with Arvinas to develop FoundationOne Liquid CDx as a companion diagnostic for use with Arvinas’ bavdegalutamide (ARV-110), an investigational novel PROTAC protein degrader targeting the androgen receptor. Arvinas’ bavdegalutamide is being developed to potentially treat men with metastatic castration-resistant prostate cancer who have progressed on existing therapies. As companion diagnostics, FoundationOne CDx and FoundationOne Liquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies.

Foundation Medicine, a cancer molecular profiling company, announced its participation in a neoadjuvant screening trial with the Lung Cancer Research Foundation and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled “LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer” (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling in the LEADER trial, which uses an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer to develop essential data that supports oncologists in their personalized treatment planning for cancer patients before surgery.

Caris Life Sciences, a molecular science and technology company, introduced its Caris Assure liquid biopsy assay. Caris Assure is a blood-based molecular profiling assay that uses a novel circulating nucleic acids sequencing approach to analyze the whole exome (cfDNA) and whole transcriptome (cfRNA) of 22,000 genes from a simple blood sample. Caris Assure captures more tumor-informed material by including DNA and RNA coverage across somatic tumors, somatic clonal hematopoiesis of indeterminate potential, and germline alterations, leading to improved performance and comprehensive molecular profiling results for the physician and patient.

InterVenn Biosciences, a clinical technology company, announced new data showing that its new DAWN IO Melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies–either pembrolizumab alone or ipilimumab in combination with nivolumab. This test was developed on InterVenn’s perspectIV platform, which can directly interrogate the blood glycoproteome–the entire set of sugars on proteins in the blood–for its own development or on behalf of partners. Because of the essential role glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making. Unlike other non-invasive methods, this test does not depend on detecting material shed by tumors and requires a significantly lower blood sample volume than conventional methods.

Avera Health, an integrated regional health care system, and Sema4, an AI-driven genomic and clinical data intelligence platform company, announced the Avera/Sema4 Oncology and Analytics Protocol (ASAP) study–a five-year commitment to population health for precision oncology care. The ASAP study will enroll 3,000 patients annually, including those with cancer or at risk for developing cancer. Study participants will receive genomic sequencing of their tumor and hereditary cancer and pharmacogenomics testing to identify targeted, personalized treatment options. Furthermore, participants will receive pharmacogenomics testing to study how variations in some genes may impact medication efficacy and safety.

AusDiagnostics announced a new distribution partnership with BGI Americas. BGI will distribute AusDiagnostics Tandemplex MT-PCR products throughout the United States. Tandemplex panels allow users to detect and differentiate between multiple pathogens that cause similar symptoms. These products provide healthcare professionals with comprehensive diagnostic information that supports decisions to deliver better patient care. This partnership will assist AusDiagnostics and BGI in expanding their footprint in molecular diagnostics to address the testing needs in the United States.

A team of clinicians and scientists from Tempus and Geisinger found that a new artificial intelligence model can accurately identify patients at increased risk of undiagnosed structural heart disease. Structural heart disease (SHD) is a group of conditions that adversely affect the heart’s valves, walls, chambers, or muscles. The Tempus and Geisinger study sought to address this diagnostic gap by developing a novel machine learning model that uses data from a 12-lead electrocardiogram to identify patients at elevated risk of undiagnosed SHD. Published in Circulation (DOI:10.1161/CIRCULATIONAHA.121.057869), the rECHOmmend model can predict any one of seven structural heart diseases diagnosable by an ultrasound of the heart. Overall, the study found that the model achieved excellent performance, exceeding the performance of any previously published model predicting any single disease.

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