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Detecting COVID-19 in Wastewater, AI-Powered Cancer Detection, Point-of-Care PCR

August 3, 2021 | More COVID-19 tests prove accurate for the delta variant, NVIDIA’s Cambridge-1 supercomputer builds synthetic brain images, biobank and practice acquisitions, and FDA companion diagnostic approvals for Foundation Medicine. 

The National Cancer Institute has launched two SIBR diagnostics grants, one for Cancer Prevention and Diagnosis Technologies for Low-resource Settings and one for At-home Screening for Hepatitis C Virus. The goal of the first solicitation is to encourages applications to develop or adapt, apply, and validate existing or emerging technologies into low-resource setting-appropriate technologies for cancer prevention early detection and/or diagnosis. Investigators must explicitly consider potential for adoption and scale-up in the local context as design criteria for technologies proposed in applications responding to this solicitation. The budget per award is up $400,000 for 12 months for phase one and up $2,000,000 for 2 years for phase two. Grant details. The purpose of the second solicitation is to develop and validate a rapid, sample-to-answer, point-of-care test for hepatitis C vaccine exposure or active infection that has the following required specifications: 1) can be used as a self-test in non-clinical settings including at home; 2) testing requires only the use of non-invasive specimens that can be safely collected at home such as (but not limited to) blood via finger prick, oral samples (e.g., saliva or buccal cells collections), or urine; and 3) achieves the same analytic performance as predicate tests that use blood for the detection of anti-HCV antibodies as a measure of exposure or HCV RNA or proteins as a measure of active infection. The budget per award is up to $400,000 for up to 12 months for phase one and up to $2,000,000 for up to 2 years for phase two. Grant details.

Qorvo has announced that its Qorvo Omnia SARS-CoV-2 Antigen Test platform completed a key milestone for the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative.  Atlanta’s Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test. The studies demonstrated 100% sensitivity/specificity for the adult population, and 83% sensitivity and 100% specificity for the pediatric group. Press release

Researchers from the Antimicrobial Resistance (AMR) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, alongside collaborators from Biobot Analytics, Nanyang Technological University (NTU) and Massachusetts Institute of Technology (MIT), have successfully developed an innovative, open-source molecular detection method that is able to detect and quantify the B.1.1.7 (Alpha) variant of SARS-CoV-2. The breakthrough paves the way for rapid, inexpensive surveillance of other SARS-CoV-2 variants in wastewater and is published in Ecotoxicology and Public Health. Paper.

Paragon Genomics has announced the publication of three scientific studies confirming that its CleanPlex SARS-CoV-2 Research and Surveillance Panel for viral detection, mutation analysis, variant tracking and epidemiological research accurately identifies important COVID-19 variants, such as the B.1.1.7 Alpha variant and the B.1.617.2 Delta variant, major variants of concern that have been implicated in surges of COVID-19 infections worldwide. The accuracy of the CleanPlex technology and its utility for variant detection and surveillance, including identification of individual viral mutations, have contributed to its adoption by hundreds of laboratories around the globe in the past 18 months. A Brazilian study from researchers at the Federal University of Rio Grande do Sul and Hospital de Clínicas de Porto Alegre published in the journal Eurosurveillance examines the association between the emergence of the SARS-CoV-2 P.1 lineage, or Gamma variant, in the northern region of Brazil and subsequent rapid growth in hospitalizations. A retrospective study from researchers at the University of Sassari and Sassari University Hospital in Italy investigated the spread in northern Italy of B.1.1.7, a SARS–CoV–2 variant of concern originally identified in the UK. And a third study, from a Paragon Genomics public health laboratory customer, describes how the CleanPlex SARS-CoV-2 Panel enabled the early identification of one of the first confirmed cases of the B.1.617.2 Delta variant in Brazil. Press release

King’s College London is using Cambridge-1 to build AI models that are able to generate synthetic brain images by learning from tens of thousands of MRI brain scans taken of patients of various ages and with a variety of diseases. The work will enable scientists to differentiate healthy brains from those that are diseased, giving them a more nuanced understanding of what diseases look like and possibly enabling earlier and more accurate diagnoses. The use of synthetic data has the additional benefit that it can ensure patient privacy since the images were AI generated. This also allows King’s to open the research to the broader U.K. healthcare community. The AI model was developed by King’s and NVIDIA data scientists and engineers. It is one of several projects taking place on Cambridge-1, the U.K.’s most powerful supercomputer, with 80 NVIDIA DGX A100 systems integrating NVIDIA A100 GPUs, BlueField-2 DPUs and NVIDIA HDR InfiniBand networking. King’s College London intends to share its synthetic data model with the greater research and startup community. Press release

PixCell Medical has signed an exclusive distribution agreement with medical diagnostics company Gamidor Diagnostics to distribute the HemoScreen, PixCell’s hematology analyzer, across Israel. This deal follows a global shift spurred by the COVID-19 pandemic towards near-patient, digitally connected testing and diagnostics. Gamidor provides systems, reagents and services to clinical laboratories, hospitals and academic research institutions in Israel, and represents world-leading diagnostics companies, including Roche Diagnostics. PixCell’s HemoScreen is the only 5-part differential CBC analyzer that is both FDA-cleared and CE-marked for point-of-care use. The portable diagnostic device delivers lab-accurate results within five minutes, significantly less time than traditional methods, removing the need for specially trained lab technicians to operate the instrument. Utilizing a patented, disposable cartridge preloaded with all necessary reagents, HemoScreen reduces reagent waste and eliminates the need for routine maintenance. With just one drop of blood, HemoScreen provides Complete Blood Count (CBC) results with 20 standard parameters, as well as comprehensive abnormal cell flagging for earlier detection of infection and certain cancer types. Press release

C2i Genomics has signed a three-part collaboration agreement with Premier, a leading healthcare improvement company, to bring AI-powered cancer detection and monitoring to health systems in the Premier network. The partnership will establish a real-world evidence council and the development of a white paper that addresses best practices in point-of-care solutions. Furthermore, C2i Genomics will partner with eight Premier members to foster the implementation of the C2-Intelligence Platform, a cancer diagnostics service that monitors the patient’s disease progression and detects trace amounts of persistent or recurrent cancer much earlier, at far lower levels, to inform better treatment decisions and improve outcomes. C2i’s cancer intelligence technology works by applying whole-genome sequencing and artificial intelligence to just a 2ml blood sample to provide up to 100x more sensitive cancer detection than competing technologies. This technology also eliminates the need to develop a patient-specific assay, enabling high performance and personalized monitoring with reduced logistic and rapid turnaround. By partnering with Premier, C2i is positioned to build a robust collaborative data set that combines Premier’s clinical data with unique whole-genome minimal residual disease (MRD) data and insights. Press release.

BioIVT has acquired Tissue Solutions, a virtual biobank based in Glasgow, UK. Tissue Solutions provides medical researchers with high quality human tissue and other biological materials for use in drug discovery, target identification and validation, assay development and validation, and biomarker and companion diagnostic development, primarily supporting research into oncology, blood disorders, and central nervous system, inflammatory, autoimmune, cardiovascular, infectious, and metabolic diseases. Tissue Solutions provides fresh, frozen, and formalin-fixed, paraffin-embedded (FFPE) control tissue and skin samples; disease state peripheral blood mononuclear cells (PBMCs) and bone marrow mononuclear cells (BMMCs); fresh and frozen blood and biofluids; normal and mobilized leukopaks; and tissue microarray slides. The company also offers custom procurement to meet client-specified inclusion and exclusion criteria. All BioIVT’s and Tissue Solutions’ biospecimens are fully consented, collected under institutional review board (IRB) oversight, and provided with the donor’s age, gender, race, disease confirmation, medications, comorbidities, and laboratory results. Press release.

Konyang University Hospital in Daejeong, South Korea and Molecular Health have signed an agreement such that the hospital will be the first facility in South Korea to use MH Guide in the personalized treatment of its cancer patients. MH Guide is an analysis software that helps molecular pathologists and oncologists interpret NGS data and make treatment decisions. The software automatically detects relevant gene variants from molecular information and identifies treatment options based on the molecular profile and ongoing trials that may be relevant to the patient. To do this, MH Guide matches molecular patient data with data derived from one of the largest growing and Molecular Health- owned knowledge platforms (Dataome). This makes MH Guide an evidence-based decision support tool that enables physicians and molecular pathologists to keep pace with the rapidly growing stock of medical knowledge and make it actionable in treating their patients. Press release

Foundation Medicine has received approval from the U.S. Food and Drug Administration (FDA) for two companion diagnostic tests. FoundationOne Liquid CDx can be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA (capmatinib) may be appropriate. TABRECTA is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. Foundation Medicine’s strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics. Press release. And FoundationOneCDx can be used as a companion diagnostic for ALUNBRIG (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This latest approval reinforces FoundationOne CDx’s ability to detect ALK rearrangements, which can be missed with alternate testing methods. Foundation Medicine and Takeda entered into an agreement to develop companion diagnostics for therapies in its late-stage lung portfolio in September 2020. Press release 

Quantum Computing, the leader in bridging the power of classical and quantum computing, is partnering with IPQ Analytics, a life sciences and healthcare analytics innovator that provides a new breed of solutions for improved diagnostics and clinical trial outcomes. Through the partnership, IPQ will analyze real world data to generate novel temporally-defined disease models by combining its unique top-down knowledge graph representation of the patient journey with QCI’s quantum-powered community detection technology. QCI’s QGraph, a component of Qatalyst, empowers drug analysts to solve the most computationally expensive graph problems. The partnership offers IPQ early access to the QDetect community-detection technology of QGraph. The resulting “next generation phenotypes” (NGP) will be used to “re-diagnose” patients in failed clinical trials to identify responsive patient subgroups; optimize payor reimbursement guidelines to reduce unnecessary testing and ineffective patient treatment; and to enhance clinical decision support for earlier, more accurate diagnoses and improved patient management. Press release.

Bryan Dechairo, Ph.D. has been appointed president and chief executive officer of Sherlock Biosciences, an engineering biology company dedicated to making diagnostic testing better, faster and more affordable. He will also join Sherlock’s board of directors. He succeeds Co-Founder Rahul Dhanda, who will continue to serve as a board member until the end of 2021 and then as strategic adviser in 2022. Dr. Dechairo joins Sherlock from Myriad Genetics, where he was executive vice president of clinical development and oversaw the development portfolio, delivering business-critical evidentiary data for value-based reimbursement and market acceptance of commercial and novel diagnostic products across six business units globally. Before joining Myriad, he was chief medical officer, chief scientific officer and senior vice president of research and development at Assurex Health, which was acquired by Myriad in 2016. He received his Ph.D. in human genetics from University College London and completed his undergraduate studies in integrative biology at University of California, Berkeley. Press release.

QuantuMDx has launched its Q-POC rapid, PCR point-of-care diagnostic system. The system and its first test, a SARS-CoV-2 detection assay, are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. Q-POC is a portable PCR system which compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device offering rapid, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. The Q-POC SARS-CoV-2 assay is contained within a sealed, single use test cassette designed for safety, ease of use and to eliminate contamination risk. On-board reagents are also lyophilised for room temperature storage, convenient shipping and a longer shelf life. Press release

RAYUS Radiology, formerly Center for Diagnostic Imaging, has acquired three imaging centers, known as Sand Lake Imaging in Orlando, Florida and a majority interest in The Radiology Research Institute, a joint venture with Dr. Stephen Bravo, an expert in neuroradiology, musculoskeletal radiology, and interventional radiology who has built a strong foundation of partnerships with clinical trial sponsors. The Radiology Research Institute will continue to provide imaging and radiology expertise on a wide variety of clinical trials for its research partners, with a focus on Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Non-Alcoholic Steatohepatitis and Irritable Bowel Disease. Press release

Volpi has partnered with Netherlands-based TOPIC Embedded Systems to expand its portfolio of optoelectronic measurement solutions and further advance its digital initiatives. The partnership enables Volpi to accelerate development of optical modules with embedded artificial intelligence, helping to improve patient lives, optimize instrument performance, and drive innovative new revenue-generating business models for customers. Leveraging TOPIC’s software, embedded intelligence will be built into Volpi optical measurement modules to help increase productivity of instruments through predictive maintenance and remote monitoring capabilities. It will also track and deliver insights faster, reduce hardware costs and generate new revenue and business model opportunities for instrument manufacturers. Product development is already underway and Volpi and TOPIC are actively collaborating on client engagements. Press release.

Oncology practices will now be able to order and track Foundation Medicine’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR platform, the two companies announced today. This integration, the first of a series planned by Flatiron, will support more efficient clinical decision making by allowing electronic ordering, order tracking and receipt of Foundation Medicine’s CGP test results all within the OncoEMR platform. The two companies are planning similar integrations with other CGP platforms and EMRs, respectively, in the oncology space, with the goal of helping every patient to realize the benefit of precision cancer care. These workflow-streamlining integrations are being designed by clinical and product experts in partnership with oncology practices. Press release

BioIVT has acquired Valley Biomedical Products & Services, Inc. located in Winchester, VA. Founded in 1986, Valley Biomedical provides specialized biological products and services for the biotechnology, research and development, and clinical diagnostics markets. It operates three business units, focused on developing research products and cell culture sera; manufacturing human and animal source blood products to client specifications; and producing non-biological liquid reagents. Valley Biomedical is also an FDA-registered medical device manufacturer, primarily producing in vitro diagnostics (IVDs). BioIVT’s cell and gene therapy clients will be able to use Valley Biomedical’s human AB serum for their drug discovery and development work, and its IVD clients will be able to employ Valley Biomedical’s biological matrices as quality control matrices for their manufacturing processes. Conversely, BioIVT’s seven donor centers will provide access to bulk biological matrices that can be processed by Valley Biomedical for cell and gene therapy or IVD applications. BioIVT will continue to operate Valley Biomedical’s Winchester facility and employ all its staff. Financial details about this transaction were not disclosed. 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. MicroGenDX’s acquisition of RTL Genomics is a reunion. Both labs were originally separate divisions of the same company, Southwest Regional PCR, and both are located in Lubbock, Tex. In 2017, MicroGenDX and RTL Genomics separated into two independent businesses. Press release.

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