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FDA-Approved Advanced Lung Cancer CDx, Thermo Fisher’s Rapid Infectious Microbe Detection Panel, More

December 27, 2022 | An artificial intelligence electrocardiogram algorithm designed to enable the early suspicion of cardiac amyloidosis; a first-of-its-kind wearable and wireless facial electromyography solution to assess subtle facial expressions and decipher emotional reactions; fluorescent dye singles out cancer cells under near-infrared light; and more. 

Based on foundational intellectual property developed at Purdue University, used at the Purdue Center for Cancer Research, and released by On Target Laboratories, the new imaging agent Cytalux helps make tumors more easily and immediately identifiable by illuminating them and making them glow against healthy, noncancerous tissue. Cancer cells divide rapidly—much faster than normal cells—and use the B vitamin folate. After being administered intravenously to a patient before surgery, Cytalux tags that folate compound with a fluorescent dye. The cancer cells grab for the folate but end up flagged with the fluorescent dye. During surgery, these cells then fluoresce under near-infrared light. The U.S. Food and Drug Administration has approved Cytalux (pafolacianine) for lung cancer surgery. Thoracic surgeons at the Center for Precision Surgery in the Abramson Cancer Center at the University of Pennsylvania led the clinical trials evaluating the imaging agent in lung cancer. Press release one and two

Anumana, an AI-driven health technology company and portfolio company of nference, has entered into a multi-year agreement with Pfizer for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis. Anumana will conduct a clinical validation trial and pursue de novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD) and aims to gain regulatory approval for the algorithm as a SaMD for the detection of cardiac amyloidosis in the U.S., Europe, and Japan. The research agreement with Pfizer will help deepen Anumana’s efforts to implement AI-enabled early detection software that can reveal signals humans cannot interpret from ECGs. The ubiquitous nature of the painless, non-invasive 100-year-old ECG test gives AI-ECG algorithms the potential to reach more patients earlier. Press release

Clinithink partnered with AstraZeneca Oncology UK in a new project to find patients with early-stage lung cancer when treatment can be more effective. The project aims to flag patients that could benefit from lung disease screening, leading to earlier diagnosis of the disease, improved patient outcomes, and reduced costs for the NHS. Using AI-based technology, the first stage of the project is a retrospective analysis of patients’ unstructured electronic medical records that will test whether it is possible and cost-effective to use the AI technology—machine learning and natural language processing—to identify both symptomatic and asymptomatic patients who are in early stages of the disease. The outputs will then be used to develop predictive models that flag high-risk individuals at a much earlier, more treatable stage of disease, improving survival rates and driving down the intensity of treatment needed. If successful, the team will develop a prospective model in mid-2023 to prove the validity of the approach in the real world. Press release

PhoreMost and ThinkCyte K.K. announced a strategic research partnership to advance modern phenotypic drug screening using artificial intelligence. The partnership leverages both companies’ distinctive technologies in high-throughput drug discovery, PhoreMost’s next-generation phenotypic screening platform, SITESEEKER, and ThinkCyte’s AI-driven cell characterization and sorting platform, Ghost Cytometry, to develop differentiated therapies for a range of diseases with an unmet clinical need. By combining SITESEEKER to identify novel druggable targets with Ghost Cytometry to identify subtle phenotypic changes in living cells, the partnership aims to develop a unique approach to high-content phenotypic screening. The research partnership will drive ThinkCyte deeper into early drug discovery and contribute to PhoreMost’s mission of “Drugging the Undruggable.” Press release

Curebase announced the release of an integrated, plug-and-play software and full trial services offering that allows sponsors of diagnostic studies to accelerate enrollment and launch their trials more quickly as the sole execution partner. This comprehensive solution includes everything a sponsor needs: no scrambling for sites or PIs, no need to start from scratch in configuring software, no lengthy, costly recruitment process, and no multi-vendor management for contract research organization services. The Curebase offering is beneficial for at-home, in vitro, and liquid biopsy diagnostics in infectious disease and oncology—all of which struggle to get products to market faster because their studies typically require enrolling thousands of patients. Curebase's decentralized clinical trial approach opens enrollment to a broader group of patients who can participate in a study with their local providers or virtually. Press release

X-trodes announced it had launched a first-of-its-kind wearable and wireless facial electromyography solution for the medical, research, and consumer communities. Facial electromyography uses electrodes to assess even the most subtle facial expressions and decipher emotional reactions, providing insights into a person's psychological and neurological status to assess affective responses better and support a medical diagnosis. The X-trodes solution comprises wireless dry-printed electro patches that conform to the musculature of the face. Requiring no gel or adhesive, they can be comfortably worn for extended periods while acquiring electrophysiological signals, providing data of unprecedented quality. Press release

Agilent Technologies announced that the U.S. Food and Drug Administration (FDA) had approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATI (adagrasib). This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. As a professional service, the ctDX FIRST test report includes broad genomic profiling on 109 genes across four types of alterations: single nucleotide variants, insertions and deletions, copy number amplifications, and fusions. The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumor DNA from plasma. This minimally invasive approach is preferred by 90% of cancer patients compared to more invasive tissue biopsy tests. Press release

The European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR) gathered an international group of vasculitis experts to update the ACR classification criteria for giant cell arteritis to reflect modern clinical practice. The final stage of the process was to validate the new classification criteria by testing it in a series of cases and comparators. Importantly, this testing phase showed that the new EULAR/ACR classification criteria outperformed the previous ones. The resulting classification criteria should be used, for study purposes, to confirm that someone has giant cell arteritis when a diagnosis of medium- or large-vessel vasculitis has already been made. EULAR hopes they will support important new research in this field and help improve the quality of results. Press release

The University of California and Stanford University researchers report that testing for levels of certain immune-related genes in an infected individual—in addition to looking for the genetic material of the virus itself—could increase diagnostic accuracy. The researchers compared gene expression data from people diagnosed with COVID-19 to those diagnosed with other viral respiratory illnesses and those with non-viral conditions. The analysis revealed that the expression of a combination of 2 host genes is strongly associated with SARS-CoV-2 infection. This 2-gene host signature is designed to be used with a viral PCR test to diagnose COVID-19 because there is still a significant overlap between the response to SARS-CoV-2 and the response to other viral infections. Press release

Scientists from the Sahlgrenska Comprehensive Cancer Center and the University of Gothenburg in Sweden evaluated the predictive potential of Profile for the Omission of Local Adjuvant Radiotherapy (POLAR). This investigational 16-gene molecular signature was developed based on gene expression differences between patients with and without local recurrence after breast-conserving surgery. Among the 429 patients with high POLAR scores, those who received adjuvant radiation therapy after breast-conserving surgery had a 63 percent reduction of local recurrence compared with those who did not receive adjuvant radiation therapy. After 10 years, 5% of patients who received radiation therapy experienced a local recurrence, compared with 7% of those who did not. Future research from Karlsson and colleagues will examine whether the POLAR gene profile can also identify patients who could safely avoid regional radiation therapy. Press release

Thermo Fisher Scientific announced the launch of the TrueMark Infectious Disease Research Panels designed to enable rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases. To effectively study outbreaks and determine disease etiology where pathogens are similar, analytically sensitive panels are needed to support laboratory research. TrueMark Infectious Disease Research Panels are analytically sensitive, real-time polymerase chain reaction syndromic panels for analyzing various infectious disease pathogens. Testing can be done from nasopharyngeal swabs, nasopharyngeal aspirate, vaginal, genital, and lesion swabs, or urine samples. These samples can also be prepared using workflows currently in most labs. For Research Use Only. Not for use in diagnostic procedures. Press release

BGI Genomics and the University of Pécs (UP) agreed to launch a joint laboratory in Hungary as part of the cooperation agreement signed between BGI Group, the parent company of BGI Genomics, and the University. This world-class facility will accelerate the development of genomic sequencing and clinical diagnostic services while strengthening BGI Genomics and the UP's leadership in genomics, bioinformatics, reproductive health, and precision medicine in the Central and Eastern European region. BGI Genomics provides training and technical support at this joint laboratory for researchers to leverage next-generation sequencing platforms to develop and deliver world-leading genome sequencing and clinical diagnostic services. Both parties seek to advance public health screening programs and integrate monitoring strategies into managing individuals' health to improve health awareness and quality of life. Press release

A group of scientists from the Department of Medicine at the University of Rochester evaluated the Breast Cancer Index (BCI)—a genomic assay—in a subset of 1,687 patients enrolled in the SOFT trial to determine whether BCI can predict prognosis and benefit from ovarian function suppression (OFS) in premenopausal women with hormone receptor-positive, early-stage breast cancer who received endocrine therapy with or without chemotherapy. After 12 years of follow-up, among patients without lymph node involvement, those with high BCI had a 98 percent increased risk of distant recurrence than those with low BCI. A similar increase was observed in patients whose cancer had spread to one to three lymph nodes. Furthermore, among patients with a low H/I ratio, adding OFS to exemestane or tamoxifen resulted in a reduced risk of recurrence after 12 years compared to treatment with tamoxifen alone (11.6 percent and 7.3 percent, respectively). The predictive benefit of the H/I ratio was observed regardless of age, lymph node involvement, and receipt of chemotherapy. Press release

To bolster Singapore’s efforts to fight COVID-19 and prepare for the next biological threat, the Lee Kong Chian School of Medicine at Nanyang Technological University, Singapore launched a new laboratory designed for research into pandemic viruses and deadly bacterial infections. The new Biosafety Level 3 laboratory will allow the safe handling of bacteria and viruses that are serious or lethal, such as those that cause COVID-19, tuberculosis, and Avian flu. At this facility, researchers will be able to safely process samples from infected patients to study the impact of the disease on the immune system, test for the pathogen’s transmissibility, and develop vaccines and diagnostic tools—activities that can only be done in a highly contained environment due to the pathogen’s infectious nature. Press release

Scientists at Klick Applied Sciences have discovered a way to transform a continuous glucose monitor (CGM) into a powerful diabetes screening and prevention tool using artificial intelligence. The team revealed how they used machine learning and just 12 hours of data from CGMs to determine whether a patient was prediabetic or diabetic. They discovered their 12-hour model correctly identified two-thirds of patients with prediabetes and showed high accuracy in identifying healthy patients and those with Type 2 diabetes. Their study—published in Nature (DOI: 10.1038/s41746-020-0283-x)—was based on mathematical modeling to determine how some underlying changes in glucose regulation cause diabetes. Press release

Charles River Laboratories International launched the Endosafe Nexus 200, expanding its robust endotoxin testing portfolio. The Nexus 200 is the next evolution of Charles River’s data integrity compliant, fully robotic instrument, capable of processing undiluted or complex serial dilutions for water, in-process, and final product testing via Endosafe Limulus Amebocyte Lysate cartridge technology in a fully enclosed system. Powered by Endosafe EndoScan-V version 6.1, the system allows data to be exported into a Laboratory Information Management System integration and provides improved traceability, security, and data management on an integrated touch screen. Automation through robotics represents an evolution of bacterial endotoxin testing and streamlines quality control. Press release

The University of North Carolina at Chapel Hill, through the Eshelman Institute for Innovation, announced a collaboration with Amazon Web Services to build an environment for startup creation that uses cloud technology to translate UNC-Chapel Hill's digital health research expertise into commercialized solutions. The partnership will support 25 projects over three years, aiming to create, fund, and build 10 successful start-up companies based out of UNC-Chapel Hill. The focus is software-forward digital technologies to advance health and wellness, enhance patient and provider experience, and improve healthcare access across five areas: enterprise systems and support, clinician services and support, patient-facing wellness and support, patient-facing diagnostic and monitoring, and patient-facing therapeutic interventions. For more information, visit UNC’s Eshleman Institute for Innovation’s website or contact the team. Press release

PreciseDx announced a collaboration with the Laboratory of Pathology, Dordrecht, Netherlands. Through this agreement, the Laboratory of Pathology will study the performance of PreciseDx’s AI-driven Cancer Risk Stratification platform, confirming its staging accuracy and role in the decision process. Designed to augment the work pathologists perform, not replace it, the PreciseDx Breast Test has shown a more accurate assessment of prognosis than current clinical features. It can address the issue of breast cancer diagnostic misclassification. The collaboration will integrate PreciseDx’s AI-enabled technology into an independent cohort of early-stage breast cancer cases with known six-year clinical outcomes. Press release

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