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Liquid Biopsy, Food Sensitivity Testing, New Lab Space: News and Products for February

March 8, 2021 | New acquisitions and partnerships for Charles River, Illumina gets Russian approval, Lumos Diagnostics signs Canadian partnership, digital twin consortium, and more.

Several bits of news from Charles River Laboratories this month. The company has entered into a strategic partnership with Cypre, a biotechnology company that is using 3D hydrogel technology to advance the understanding of the tumor microenvironment and predict therapeutic efficacy. The partnership will provide Charles River clients with access to Cypre’s proprietary 3D tumor model platform, Falcon-X, which will expand Charles River’s 3D in vitro testing services to further optimize immuno-oncological approaches for its clients. Press release. Charles River also announced a definitive agreement to acquire Cognate BioServices, Inc., a premier, cell and gene therapy contract development and manufacturing organization for approximately $875 million in cash, subject to customary closing adjustments. The transaction is expected to close by the end of the first quarter of 2021, subject to regulatory requirements and customary closing conditions. Press release. Finally, Charles River has announced a strategic partnership with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies. Kibur’s IMD provides an opportunity to transform how researchers may assess efficacy of oncology compounds in vivo as both individual and combination therapies. Kibur’s microdevice technology can hold up to 20 different compounds for local administration, which allow it to measure interactions between disease tissue and microdoses of therapies to predict the optimal drug regimen; rapidly test multiple combinations at once in vivo in most solid tumors​; and dose therapies directly into disease tissue, allowing for investigative studies of early-stage compounds where pharmacokinetic properties are poorly understood. Press release.

Illumina’s NextSeq 550Dx platform and associated reagent kits have received medical device registration in Russia, as have reagents for the MiSeq Dx which was approved previously as a medical device. Both of these in vitro diagnostic (IVD)-ready solutions are available to customers and third-party developers to create diagnostic solutions using the technology. These registrations will catalyze the expansion of sequencing-based clinical diagnostics across the country. Sequencing platforms, and the reagents that drive them, must be approved separately in Russia by the medical device regulatory agency, Roszdravnadzor. Illumina’s strategic partner in Russia and CIS, R-Pharm, led the regulatory process and this is the first approval of complete sets of sequencing instruments plus reagents. Press release.

Lumos Diagnostics has announced a Canadian distribution partnership with Northern Diagnostics to bring the FebriDx test into Canada. FebriDx is a rapid, in-office POC test that uses a simple fingerstick blood sample to provide clinicians with a rapid assessment of the body’s host immune response to an acute respiratory infection (ARI) spanning from runny nose to sore throat or cough. The FebriDx test helps to differentiate common viral ARIs, including influenza, that may necessitate isolation from bacterial infections that require antibiotic therapy. This can assist not only with proper diagnosing and triage but also reduce the over-prescription of antibiotics, which are ineffective in viral infection. Northern Diagnostics, based in Winnipeg, Manitoba specializes in the provision of diagnostic medical equipment and POC rapid tests to a customer base ranging from small, privately-owned clinics to national healthcare systems. Press release.

YorkTest, one of the USA and UK’s market leaders in Food Sensitivity testing, is proud to announce a new partnership with Evexia Diagnostics, a clinical laboratory and medical distributor focusing on functional and integrative medicine. Effective immediately, Evexia Diagnostics will offer YorkTest’s flagship Premium Food Sensitivity Tests to clinicians. With a network of more than 6,000 partner doctors and nutritional therapists in the US, Evexia’s holistic philosophy is all about empowering clinicians to support wellness by treating the whole system and not just the symptoms. The partnership with YorkTest will provide clinicians with a remote diagnostic tool that will more quickly and efficiently identify trigger ingredients that may be causing patient discomfort and illness. The partnership also signals YorkTest’s continued growth in the US. Press release.

LabCentral, the first-of-its-kind shared laboratory space designed as a launchpad for high-potential biotech startups, today announced a total of $22.4 million in sponsorship commitments for LabCentral 238, a fully functional life sciences laboratory with a focus on scale-up bio-manufacturing. Thermo Fisher Scientific and Waters Corporation join Astellas and the Massachusetts Life Sciences Center (MSLC) as sponsors. Part of the Massachusetts Institute of Technology’s (MIT) South of Main Street (SoMa) Development in the heart of Kendall Square’s innovation hub, LabCentral 238 is currently under construction and is expected to open in November 2021. Press release.

ExEm Foam ((air polymer-type A) intrauterine foam), the only FDA-approved contrast agent for ultrasound tubal patency testing, is now available at select fertility clinics nationwide. The Foam procedure, a new ultrasound technique of hysterosalpingo foam sonography (HyFoSy), uses ExEm Foam to assess whether there may be a blockage in the fallopian tubes in women with known or suspected infertility. The innovative imaging technique offers a less complicated and less invasive alternative to laparoscopy and dye, the gold standard for diagnosing tubal patency. The outpatient tubal assessment is also associated with significantly lower pain scores as compared to the standard of care, X-ray hysterosalpingography (HSG), and does not require the use of radiation and iodine. Press release.

Digital Twin Consortium and FIWARE Foundation have entered into a collaborative agreement to accelerate the development, deployment, and wide-scale adoption of open digital twin technologies. Digital twins are growing their capabilities and sophistication. However, grasping their full potential may require integrating systems and data across entire organizational ecosystems. That's exactly where both organizations are set to create value and synergies. As part of the collaboration, both have agreed to collaborate on digital twin standardization requirements, and the open-source implementation of jointly identified standards requirements; realize interoperability, based on information exchange by harmonizing technology components and other elements; and align work in horizontal sectors toward the adoption of results in various vertical domains through reference use cases and pilot projects; and foster adoption among academia, researchers, and companies (among others) of open standards for digital twins and open-source technology, used as reference implementation of such standards. Press release.

Vocalis Health has announced results of a clinical study conducted in collaboration with the Municipal Corporation of Greater Mumbai (MCGM) at their NESCO COVID-19 Center to validate Vocalis Health’s COVID-19 screening tool, VocalisCheck. VocalisCheck is a software-only product that can be accessed via smartphones or other devices. Users simply count from 50 to 70, their voice recording is transformed to a picture (spectrogram) containing 512 features. That picture is then compared using AI machine learning/deep learning techniques to a composite picture based upon the voice recordings of COVID-19 positive participants in clinical trials to determine whether there is a high or low correlation between them. The MCGM study included over 2,000 participants who spoke numerous languages including English, Hindi, Marathi and Gujarati. Results from an unblinded validation set of 288 participants demonstrated an AUC of 0.88, which translated to accuracy of 81.2 percent, sensitivity of 80.3 percent and specificity of 81.4 percent. VocalisCheck has also obtained a CE mark. VocalisCheck is the first device with CE mark approval for its medical intended use of screening for COVID-19. Press release.

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