CLN - Industry Playbook

Thermo Fisher, NX Prenatal to Develop Tests for Pregnancy-Related Complications

Industry Playbook: June 2019

Thermo Fisher Scientific has entered a collaboration with NX Prenatal, a company focused on the detection, monitoring, and management of pregnancy-related complications using novel exosome-based methods. Together, the two partners plan to develop clinical mass spectrometry (MS)-based proteomics assays to monitor fetal health in utero and assess the risk of adverse outcomes, including preterm birth and preeclampsia. The new tests will combine NX Prenatal’s NeXosome platform with Thermo Fisher’s liquid chromatography (LC)-MS instrumentation to analyze exosome-derived proteomic biomarkers of maternal-fetal health. NX Prenatal’s NeXosome platform enriches maternal blood samples for microparticles such as exosomes, which play key roles in maintaining certain physiological balances between the mother and fetus during pregnancy. Aberrations in these balances have been shown to correlate with the likelihood of adverse pregnancy outcomes.

“At NX Prenatal, we are developing novel assays and noninvasive early warning systems to detect subtle molecular changes in the maternal-fetal environment,” said Brian D. Brohman, CEO of NX Prenatal. “Our collaboration with Thermo Fisher Scientific brings together our novel NeXosome platform with their leading analytical technology…in an effort to provide the precision necessary for personalized diagnostic solutions to improve health outcomes for both mother and child.”

FH Foundation Strives to Improve Homozygous Familial Hypercholesterolemia Diagnosis

The FH Foundation has launched the Flag, Identify, Network, Deliver (FIND) HoFH program to identify individuals at risk for homozygous familial hypercholesterolemia (HoFH), a more severe form of FH. FIND HoFH will build on the FH Foundation’s FIND FH initiative, which was established in 2013. Both FIND FH and FIND HoFH use machine learning and big data to analyze national healthcare encounter and laboratory data in order to identify individuals who should be evaluated by clinicians for FH and HoFH. FH Foundation has also entered a multipartner collaboration so that individuals identified by FIND HoFH can receive free genetic counseling through Genome Medical and free confirmatory genetic testing through Invitae. “Genetic testing for HoFH can make a big difference for young people, who may be facing serious cardiovascular risks that might otherwise be missed due to their age,” said Robert Nussbaum, MD, chief medical officer of Invitae. “The FIND HoFH program is an excellent example of combining technology and public health techniques to better identify young people who are at risk.”

Cleveland Clinic Spin-Off, Shivom to Help Patients Manage Hereditary Conditions

Family Care Path (FCPI), a spin-off company from Cleveland Clinic, has joined forces with Shivom, a biotechnology data and analysis company that aims to optimize the way genetic data is shared, secured, and analyzed through blockchain and artificial intelligence technology. Together, the partners will integrate FCPI’s MyLegacy and CarePathConnect applications within Shivom’s marketplace. MyLegacy is Cleveland Clinic’s family history collection and disease risk assessment tool, which uses proprietary algorithms based on practice guidelines developed by the Cleveland Clinic Genomic Medicine Institute and which FCPI has exclusively licensed. CarePathConnect is FCPI’s international telehealth counseling network that enables patients to discuss their genetic health risk conditions with genetic counselors and learn about the benefits and limitations of genetic testing via a HIPAA-compliant web-based video platform. Together, these two offerings will give Shivom’s customers access to a personalized health risk profile, as well as guidance on how to take proactive steps against hereditary conditions found within their genetic data.

Cellgen, Genomic Testing Cooperative Join Forces on Immuno-Oncology Co-Diagnostics

Cellgen Diagnostics and Genomic Testing Cooperative (GTC) have teamed to help accelerate global development of companion diagnostics for oncology therapeutics. The companies expect their collaboration to focus initially on immuno-oncology drugs. Cellgen will contribute to the partnership a fully automated companion diagnostic platform that can be used across multiple drug pipelines, as well as its Immune Panel assays. According to Cellgen, these assays will enable pharma groups in research and development to use a standard approach to patient stratification and therapeutic response monitoring during clinical trials. Additionally, the collaboration will leverage GTC’s capabilities in next-generation sequencing, machine learning, and deep learning to comprehensively profile the tumor microenvironment and create unique patient phenotypic profiles. With the synergies between the two companies, the partners ultimately aim to provide the pharmaceutical industry with an integrated immuno-oncology pipeline that seamlessly moves from discovering and validating biomarkers to developing companion diagnostics.

RxGenomix, Coriell Life Sciences Team to Support Pharmacogenomics Programs

RxGenomix and Coriell Life Sciences are partnering in an effort to advance clinical pharmacogenomics. RxGenomix has created the RxGenomix Training Program in Pharmacogenomics, a pharmacist-led solution to help healthcare providers apply pharmacogenomics to patient care. Coriell Life Sciences, in turn, offers a suite of tools to healthcare providers that provide comprehensive pharmacogenomic risk analysis, accounting for genetic factors alongside risks related to drug interactions, age, cognitive impairment, and numerous other considerations. The companies’ new partnership will combine RxGenomix’s process for implementing pharmacogenomics with Coriell’s risk analyses, reporting solutions, and population-level healthcare analytics. “After surveying the market, we were thrilled to find Coriell Life Sciences as having the perfect complementary bioinformatics services to drive our continued strategy of pharmacist-led [pharmacogenomics] solutions,” said Blake Keller, PharmD, RxGenomix chief operating officer.

The two companies hope this collaboration will enable healthcare entities to evaluate the potential effectiveness of pharmacogenomics programs and target their efforts for the greatest patient benefit.

Foundation Laboratory, Yikon to Offer Noninvasive Preimplantation Genetic Testing

Yikon Genomics is collaborating with Viazoi, a genetic testing and wellness division of Foundation Laboratory, to launch clinical noninvasive preimplantation genetic testing for aneuploidy (PGT-A) in the U.S. Yikon is a single cell sequencing company focused on reproductive health and cancer diagnostics based in Shanghai, with global operations out of the U.S. The company’s noninvasive PGT-A test screens embryos for chromosomal aneuploidy prior to implantation without an invasive embryonic biopsy. Instead, the culture medium used during in vitro embryo culture is collected and then processed for aneuploidy screening through library preparation and next-generation sequencing (NGS). Viazoi has validated Yikon’s noninvasive PGT-A test and together with Yikon is selling the service in the U.S. “It was a very obvious decision to partner with Yikon and offer our [NGS] production capacity to support Yikon’s noninvasive [preimplantation genetic screening] testing as there is valuable genetic information at the embryonic level that parents can review and make very important decisions with,” said Zareh Baghoomian, DDS, vice president of operations at Viazoi.