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New COVID-19 Diagnostics, Myriad Sells myPath, Nanoscale Diagnostic Sensors

May 3, 2021 | New sequencing project looks at developmental differences, Castle Biosciences to acquire Myriad’s myPath, AI tools for cystic fibrosis detection, updates in COVID-19 diagnostics, and more new products and updates from around the industry.


National Institutes of Health is funding $29 million in additional grants for the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. This funding was supported by the American Rescue Plan. The awards will provide $15 million to 11 teams already conducting research and outreach to help strengthen COVID-19 vaccine confidence and access, as well as testing and treatment, in communities of color. An additional $14 million will fund 10 new research teams to extend the reach of COVID-19 community-engaged research and outreach. Press release.

Illumina, GeneDx (a wholly owned subsidiary of BioReference Laboratories) and The University of Washington are collaborating to study early detection of developmental differences in children. The project, SeqFirst, will provide early access to whole-genome sequencing (WGS) to 100 children suspected of having developmental differences at the point of diagnosis. Scientists anticipate this will lead to earlier, more rapid diagnoses, as well as lowering health care costs and improving subsequent treatment for these children. Illumina will support the study by providing advanced sequencing reagents and GeneDx will perform state-of-the-art diagnostic WGS. Press release.

Castle Biosciences has signed a definitive agreement to acquire all of the equity of Myriad myPath, LLC (Myriad myPath Laboratory), from Myriad Genetics. Myriad myPath Laboratory is a CLIA-certified laboratory in Salt Lake City, where the myPath Melanoma 23-gene expression profile (GEP) test was developed and is currently owned and offered. Castle is acquiring Myriad myPath Laboratory for $32.5 million. Castle will finance the acquisition price with cash and cash equivalents on hand. The transaction is expected to close approximately four weeks post signing, at which time Castle will be the successor owner of Myriad myPath Laboratory. The transaction is subject to customary conditions to closing. Castle currently offers DecisionDx DiffDx-Melanoma, a 35-GEP test designed to characterize difficult-to-diagnose melanocytic lesions. myPath Melanoma is a distinct test, which Castle anticipates will complement its current offerings and enable Castle to provide the most comprehensive molecular testing solution for difficult-to-diagnose melanocytic lesions. DecisionDx DiffDx-Melanoma and myPath Melanoma are both commercially available and will remain available through Castle and Myriad, respectively, throughout the transaction period. As the successor owner, upon closing, Castle will be the sole provider of myPath Melanoma. Press release.

C4Diagnostics announced the CE marking and commercialization of C4Covid-19 Human for the rapid diagnostic of Covid-19 from a saliva sample. The performance of the test was calculated upon a largescale clinical trial of 1320 participants, carried out in collaboration with Synlab Provence Laboratories. Sensitivity is 86% and specificity is 97.5%. C4Covid-19 Human is an in vitro diagnostic test (IVD) designed to address the growing need for saliva-based screening, combining high performance while being deployable outside the clinical laboratory. Based on RT-LAMP technology, which is close to RT-PCR, it requires minimal equipment, namely a portable reader-analyzer, and the result is delivered in less than 30 minutes. Press release.

Hillrom has launched the new Welch Allyn PanOptic Plus Ophthalmoscope and the Welch Allyn MacroView Plus Otoscope. The new devices represent advancements that build on more than 100 years of the company's innovation in physical assessment tools and a new standard of care in exam rooms. The new Welch Allyn MacroView Otoscope features a new, one-of-a-kind, LumiView clear ear speculum, with four times the brightness through an adult speculum when compared to a standard ear speculum. The MacroView Plus otoscope enables clinicians to move quickly from an optical exam to digital image capture. When used along with Hillrom’s free iExaminer Pro App, clinicians can securely save and share ear images for tracking, trending and easy consultations with specialists. The new Welch Allyn MacroView Otoscope features a new, one-of-a-kind, LumiView clear ear speculum, with four times the brightness through an adult speculum when compared to a standard ear speculum. Press release.

MIP Diagnostics has launched its COVID-19 nanoMIP for diagnostic sensors, a synthetic alternative to antibodies that offers ultra-high sensitivity for the next wave of COVID-19 antigen detecting devices. nanoMIPs are nanoscale Molecularly Imprinted Polymers, commonly known as synthetic antibodies. They are manufactured around a template molecule in a highly controlled chemical process. In this case, the nanoMIP has been manufactured around the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, specific to the COVID-19 virus. The COVID-19 nanoMIP has now undergone significant testing and has demonstrated an ultra-low limit of detection of 5 fg/ml to the RBD spike protein in a sensor device. Alongside this exceptional sensitivity performance, COVID-19 nanoMIPs also introduce an extra level of stability compared to biological receptors such as antibodies, and have been proven to withstand temperatures up to 121°C. Press release.

OpGen has announced that its strategic collaboration with the New York State Department of Health (“DOH”) is being extended through September 30, 2021. The collaboration intends to develop a state-of-the-art solution to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. Having successfully achieved all of the milestones of the first and second year phases for the development of an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance, OpGen will continue to work together with DOH’s Wadsworth Center and the participating healthcare systems to expand the reach of the platform, increase the volume of testing, and enhance data collection. OpGen is providing its Acuitas AMR Gene Panel for rapid detection of multidrug-resistant bacterial pathogens along with its Acuitas Lighthouse Software for high resolution pathogen tracking. The six-month extension and expansion contract includes a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to an additional $540,000 to OpGen, which includes unused budget resources from the second-year phase. Press release.

Renalytix AI has entered into an exclusive option agreement with Joslin Diabetes Center for patent filings on certain additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelX in vitro prognostic platform. In 2018, RenalytixAI secured an exclusive license from Joslin Diabetes Center to intellectual property relating to sTNFR1 and sTNFR2, both of which have been extensively validated as highly prognostic biomarkers in multiple settings and are integral to the KidneyIntelX test. The novel biomarkers included in the new option agreement have the potential to provide additional clinical utility for understanding early disease progression and risk of kidney failure, therapeutic response, and the mechanistic pathways of kidney disease beyond the inflammatory and tubular injury markers that are currently captured by KidneyIntelX. RenalytixAI plans to begin evaluating these novel biomarkers in expanded clinical validation studies beginning in the second half of 2021. Press release.

Cofactor Genomics has begun the first multicenter clinical trial of its OncoPrism diagnostic assay using the company’s patented approach to generating multidimensional immune biomarkers. Fifteen hospitals and healthcare networks, including Mayo Clinic, MultiCare Institute for Research and Innovation, and Revive Research Institute, are currently enrolling in the PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial to evaluate use of the OncoPrism test in patients with recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) to effectively predict a patient’s response to immunotherapy. The company expects additional sites to join the trial before the end of 2021. While the trial will initially recruit RM-HNSCC patients, the protocol is approved for recruitment of patients with 10 additional indications where independent market research has identified an unmet clinical need in predicting tumor response to immunotherapy. Specimens collected in the study will be analyzed at Cofactor’s CAP/CLIA accredited laboratory. Press release.

QIAGEN has launched QIAseq DIRECT SARS-CoV-2 Kit, a viral genome enrichment and library preparation solution that significantly reduces library turnaround times and plastics use compared with ARTIC project protocols, the primer-based approaches for next-generation sequencing that are considered the gold standard in NGS-based characterization of SARS-CoV-2 genomes. QIAseq DIRECT SARS-CoV-2 supports sample multiplexing with up to 768 Dual Molecular Indices—unique markers tagged to molecules in a sample to eliminate errors from downstream analysis—in a library preparation workflow from extracted viral RNA that reduces turnaround time to as little as four hours. This also increases the number of samples per sequencer to over 6,000 samples on the highest-throughput instruments. The kit also cuts plastics usage by 50%, drastically reduces hands-on time, requires no fragmentation or ligation reactions and can be readily automated with robotic liquid handlers. The viral enrichment approach delivers superior uniformity of coverage across the SARS-CoV-2 genome as well as deeper sequencing performance compared with the most widely used amplicon-based options. Press release.

2bPrecise added functionality in the 2bPrecise winter 2021 release. Notable features include: introduction of an innovative 2bPrecise Precision Timeline, enabling clients to access previous tests, diagnoses, labs and notes in a single view to eliminate time-consuming “document hunting” during clinical decision-making; PGx candidate identification support to determine patient cohorts at greatest risk for drug-gene interactions (especially in those taking multiple medications); broader PGx knowledgebases to incorporate the latest medication ontologies and scientific discoveries; additional lab integrations to enhance insights from tumor test results (somatic), including identification of additional biomarkers and chromosomal alterations; and functionality that allows clinicians to easily search for negative genetic/genomic findings to easily determine if a specific condition or genotype was covered by an ordered test. Press release.

RegDesk has released an updated version of its 'Dash' platform. Dash 2.0 incorporates an innovative application builder that cuts the submissions process from months to hours and facilitates faster approvals. Registering medical devices has become increasingly challenging in recent years as nations struggle to update regulations in response to rapid technological advances in the industry. The result is labyrinthine approval processes that often differ from country to country. RegDesk's application builder uses AI-powered software to automatically prepare submissions dossiers and autofill applications with archived product and regional targeting information. Internal data shows that with one click, on average, 40-50% of certain applications can be completed. Besides faster application building, the tool also ensures greater compliance with individual nations' regulatory requirements. RegDesk utilizes the largest and most up-to-date global regulatory intelligence database on the web to guide users through the application process, potentially saving devices from years of regulatory limbo. Press release.

Thirona has developed an AI algorithm that revolutionizes cystic fibrosis (CF) care. The new algorithm, coined PRAGMA-AI, allows for fast, automated analysis of CT scans of patients with CF to detect and quantify lung abnormalities related to CF. These quantifications are critical in determining the status of the patient and determine optimal treatment paths but are not feasible to be performed by humans in clinical care. The release of PRAGMA-AI paves the way for large-scale usage in clinical trials and clinical care for better diagnostics, patient monitoring, and treatment planning. Press release.

Proscia and Ibex Medical Analytics have entered into a strategic partnership to support pathologists in detecting prostate cancer, the second leading cause of cancer death among men in the United States. Through the collaboration, the partners will advance the use of computationally-enabled workflows leveraging AI, which drive accuracy, efficiency, and quality gains in routine pathology diagnosis. Proscia and Ibex have joined forces to deliver a unified software solution that powers AI-enabled workflows for prostate cancer diagnosis, helping laboratories to drive meaningful productivity and quality gains. The joint product integration will bring together Ibex’s Galen Prostate solution with Proscia’s Concentriq image and data management platform, introducing AI-powered triaging, cancer detection, and grading of prostate core needle biopsies into routine workflows. Galen Prostate is already deployed in laboratories worldwide and supports pathologists with real-time quality control by alerting on misdiagnosed and mis-graded cancers. Press release.

PerkinElmer has launched two solutions to identify SARS-CoV-2 variants. Upon detecting a positive case using a first-tier diagnostic assay, labs can now use second-tier assays like the new PerkinElmer PKamp VariantDetect (RT-PCR) and NEXTFLEX Variant-Seq (NGS) kits to provide further information about mutations in the sample. Both kits are currently intended for research use only. Press release.

PerkinElmer has also completed its acquisition of Oxford Immunotec Global PLC, the second largest company in the latent tuberculosis (TB) market. By bringing Oxford’s expertise and technologies into the PerkinElmer Diagnostics portfolio—including the Oxford T-SPOT.TB test—the combined team is helping to combat two of the most highly infectious disease causes of death worldwide: tuberculosis and COVID-19. Press release.

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