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HemaChrome Wins the NIH’s RADx Tech for Maternal Health Challenge, Next-Generation Pathology Analysis Enriches Breast Cancer Grading, More

February 23, 2023 | A remote diagnostic platform offers at-home infectious disease tests and efficiently manages lab processes and data; a secure nationwide Microsoft cloud platform provides streamlined communications and AI insights from diagnostic imaging to improve healthcare outcomes and costs; a non-small lung cancer test provides clinicians with actionable clinical insights and a better understanding of their patients’ personalized cancer dynamics; and more. 

HemaChrome has won phase 1 of the National Institutes of Health’s RADx Tech for Maternal Health Challenge for using smartphone technology to noninvasively and instantly measure blood hemoglobin levels. Because it won, HemaChrome will access NIH’s in-house and in-kind support to speed up its technology's development, validation, and commercialization. HemaChrome meets twice a week with the NIH RADx team of experts as part of the process to proceed to phase 2 of the challenge. In addition, HemaChrome received support from the U.S.-Korea Conference Startup Pitch Competition and the 2020 NIH Technology Accelerator Challenge. The company also has received support from Purdue Innovates and licenses technology through the Purdue Research Foundation Office of Technology Commercialization. Press release

Hurdle and CloudLIMS announced a strategic partnership marking the first integration between a diagnostic-as-a-service platform and a software-as-a-service LIMS provider. The partnership combines Hurdle’s remote diagnostic platform and CloudLIMS’s secure, purpose-built diagnostics LIMS to empower labs to offer at-home tests and efficiently manage lab processes and data. As a result of this collaboration, Hurdle’s partner labs, such as reference labs and clinical diagnostic labs, will now be able to seamlessly manage lab data, automate workflows, and follow regulatory compliance, such as HIPAA, GDPR, CLIA, ISO 15189:2022. Diagnostic labs can now extend their services to patients in infectious disease hotspots, remote locations, and underserved communities who cannot travel to the lab location to get themselves tested. Press release

NANO-X IMAGING LTD announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, has connected to the Nuance Precision Imaging Network. This secure nationwide cloud platform empowers collaborative care teams with streamlined communications and AI insights from diagnostic imaging within existing workflows to improve healthcare outcomes and costs. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed. Powered by Microsoft Azure, the Nuance Precision Imaging Network provides access to an entire ecosystem of AI-powered tools and insights within clinical workflows to more than 12,000 healthcare facilities and 80% of U.S. radiologists. Nuance is a Microsoft company. Press release

DermTech announced that U.S. General Services Administration recommended the Company’s foundational assay be included in the DermTech Melanoma Test (DMT) for coverage by the Veterans Health Administration (VHA). The VHA is the largest integrated healthcare system in the U.S., providing care at 1,298 healthcare facilities. This coverage recommendation makes the foundational assay of the DMT available to the VHA’s over 9 million enrolled Veterans. The DMT is an innovative, non-invasive way to enhance melanoma detection with a greater than 99 percent negative predictive value. DermTech’s total covered lives in the U.S. are now approximately 124 million, which includes 68 million for Medicare/Medicare Advantage and 56 million for commercial and governmental payers. Press release

PreciseDx announced that the New York State Department of Health approved the PDxBr, a lab-developed test designed to enrich breast cancer grading and improve risk categorization. PreciseDx can begin commercially testing patient samples in New York through its CLIA-certified laboratory with this approval. The assay was developed leveraging the power of the PreciseDx Platform and the AI-driven Morphology Feature Array. This technology has now enhanced pathology interpretation with objective, quantifiable, and highly accurate data. This data, also part of the submission to New York State, provides more robust information regarding patient disease status and represents the next generation of pathology analysis. Press release

Delivering a boost to immuno-oncology and immunotherapy researchers, Cytek Biosciences announced a strategic partnership with clinical diagnostics products company Bio-Rad Laboratories. Under the terms of the agreement, Bio-Rad’s exceptionally bright, high-performing new StarBright Dyes will be available to Cytek to develop and commercialize reagent products to support high-parameter applications on Aurora and Northern Lights flow cytometry systems. Bio-Rad’s StarBright Dyes are designed to be stable with superior brightness, narrow excitation, and emission characteristics to minimize spillover and improve specific cell populations' resolution. Bio-Rad’s StarBright Dyes complement Cytek’s cFluor family of proprietary dyes, providing a wider variety of color options for highly multiplexed panel design and application development. Bio-Rad StarBright Dye conjugates can also seamlessly integrate into Cytek immune profiling assays. Press release

Soundable Health and Valensa International announced a collaboration on evaluating the progression and management of lower urinary tract symptoms (LUTS) using proudP, Soundable’s FDA Class II mobile uroflow monitoring application to showcase the clinical usefulness and convenience of proudP in LUTS monitoring. This collaboration will closely observe the progression of LUTS management in real life with the intake of Flomentum saw palmetto extract, a dietary supplement that promotes prostate and urinary health in men. The two companies hope that this collaboration will clearly show the versatility and convenience of proudP, not only for patients or physicians but also for pharmaceutical or dietary supplement researchers. Press release

Babson Diagnostics announced the launch of BetterWay Blood Testing. The service begins with a proprietary fingertip capillary blood collection methodology that does not require a phlebotomist and is simpler, easier, and potentially less stressful than traditional venipuncture. A sample preparation device placed at the pharmacy guides the technician and is designed to reduce diagnostic errors by automating preanalytical tasks such as labeling, mixing, and centrifugation. BetterWay Blood Testing brings these innovations together to enable blood testing that requires only one-tenth the sample volume of venipuncture methods without sacrificing quality, accuracy, or the number of possible tests. Press release

A new smartphone application owned by Neuronics Medical—called FAST.AI—may help people with a stroke, or their family and caregivers, recognize common stroke symptoms in real-time. FAST.AI is a fully automated smartphone application for detecting severe strokes using machine learning algorithms to identify facial asymmetry (drooping of the muscles in the face), arm weakness, and speech changes—all common stroke symptoms. The smartphone application uses a facial video of the patient to examine 68 facial landmark points, sensors that measure arm movement and orientation, and voice recordings to detect speech changes. Press release

OncoHost announced the official launch of its PROphet non-small lung cancer (NSCLC) Test in the United States. The PROphet NSCLC Test provides clinicians with actionable clinical insights into optimal first-line therapeutic choices and a better understanding of their patients’ personalized cancer dynamics. Requiring just one pre-treatment blood test, PROphet scans approximately 7,000 proteins in a patient's blood plasma and delivers a report that predicts their clinical benefit from anti-PD-1/PD-L1 immunotherapy-based treatment plans. The PROphet NSCLC test accurately predicts a patient’s clinical benefit and associated overall survival differences with single agent versus combination treatment plans. Press release

Sherlock Biosciences announced the acquisition of Sense Biodetection (Sense). The acquisition accelerates Sherlock’s go-to-market strategy by adding Sense’s Veros instrument-free rapid molecular test platform and manufacturing capabilities, enabling the vision of highly accurate and affordable diagnostics that can be used anytime, anywhere. Coupled with Sherlock’s proprietary engineering biology tools, including the first FDA-authorized use of CRISPR technology, this transaction enables Sherlock to bring highly accurate, advanced, handheld tests to global consumers for a wide range of diseases from respiratory and sexual health to global health outbreak response. Press release

Bio-Rad Laboratories announced the launch of the CFX Opus Deepwell Dx Real-Time PCR System, a real-time PCR system listed with the U.S. Food and Drug Administration for in vitro diagnostic testing and developed under the European Union’s regulations for in vitro diagnostic medical devices (EU 2017/746). The CFX Opus Deepwell Dx Real-Time PCR System system offers accurate and precise quantification with flexibility for reactions up to 125 µl in a 96-well format for quantitative PCR diagnostic assays. The CFX Opus Dx Real-Time PCR System is also available in a 96- and 384-well reaction block format. CFX Opus Dx Real-Time PCR Systems offer easy-to-use desktop management and analysis software with integrated security features for electronic signature, audit, and user control. Press release

Verisense Health launched as a digital health software and data management company to provide sponsors with cost-efficient access to a digital biobank of longitudinal raw patient data. The new company is a spin-off of Dublin-based wearable technology services and sensor manufacturer Shimmer Research. Verisense Health will also assume the Verisense Digital Health Panel (DHP) ownership to provide clinical researchers access to raw, real-world, digital health ground-truth sensor data. Going forward, the Verisense platform will be open to non-Shimmer Research hardware. In addition, the Verisense DHP is recruiting clinical study participants and healthy volunteers to its institutional review board-approved longitudinal study. Press release