Pandemic Infuses New Urgency Into Effort to Develop Genomics-Based Early PTSD Detection Diagnostics

In addition to death and dislocation, the global COVID-19 pandemic is likely to spawn a crisis in mental health, including a spike in post-traumatic syndrome disorder (PTSD) cases. With this in mind, a pair of diagnostic firms—one in genomics and the other in AI—have teamed up to develop new biomarkers and methodologies that can be used for early detection of the condition. The Partners The current survey-based methods of early PTSD identification tend to be subjective and biased due to the stigma associated with the condition. Recognizing the need for unbiased genomic and data-driven technologies, TruGenomix, a Maryland-based developer of next-generation-based genomic tests for PTSD formed by a pair of military veterans steeped in behavioral health research, entered into talks with BlueBee, the California-based provider of a rapidly configurable omics data platform, about collaborating to create a biomarker-based risk assessment for early PTSD identification. When the pandemic hit, it infused the project with a new sense of urgency. The Partnership On May 20, the companies announced their new strategic partnership. The plan calls for combining BlueBee’s expertise in AI and optimizing data flow with TruGenomix’s PTSD genomics data and analytics. Specifically, the partners will leverage BlueBee’s platform to aggregate, train and model DNA, RNA and methylation data alongside patient data and metadata from TruGenomix. The End Game The ambitions behind the collaboration are huge. TruGenomix and BlueBee have set out to fuse genomics and digital technology to revolutionize behavioral healthcare by speeding up insight generation and laying the foundation for an industrial-scale, clinical-grade data operation that can be applied not only to PTSD but other conditions. “For something as complex as human behavioral and mental health, a data strategy must be at the core of R&D,” noted TruGenomix co-founder and Chief Scientific Officer Tshaka Cunningham in a statement.

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Here’s a summary of other key strategic diagnostic deals announced in May 2020:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS
Partner 1	Partner(s) 2+	Deal Summary
Bio-Techne	Mount Sinai Health System	Objective: Produce and distribute Mount Sinai SARS-CoV-2 serology testing kit Dynamic: Bio-Techne to collaborate with Kantaro Biosciences, a joint venture of Mount Sinai and Renalytix AI
Thermo Fisher Scientific	WuXi Diagnostics + Mayo Clinic	Objective: Develop COVID-19 total antibody test Dynamic: Mayo Clinic clinically evaluating Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test to run on open instrument platform for diagnosis of COVID-19 during acute and recovery stages
Ambry Genetics	Volpara Health Technologies	Objective: Link Volpara’s cancer screening and practice management platform with Ambry Genetics’ program for identifying high-risk breast cancer patients Dynamic: Volpara Aspen Breast software to include online ordering process for Ambry genetic tests Volpara Density software for assessing volumetric breast density to be included in Ambry’s Comprehensive, Assessment, Risk, and Education (CARE) program
Genetron Health	Darui Biotechnology	Objective: Develop pathogenic microorganism detection products on Genetron sequencer Dynamic: Detection kits to run on Genetron S5 next-generation sequencer Genetron to help Darui seek regulatory registration of its reagent kits
Proteomedix	Dynex Technologies	Objective: Develop automated workflows for Proteomedix’s Proclarix prostate cancer test Dynamic: Proteomedix to sell Proclarix with the Dynex instrumentation on which test was clinically validated Make protocols for test available for Dynex DS2 and Agility platforms
Bayer	ArcherDX	Objective: Broaden patient access to comprehensive genomic testing that includes NTRK1, NTRK2 and NTRK3 gene fusions and improve identification of treatment options for patients with TRK fusion cancer Dynamic: Develop NGS-based companion diagnostic test for Bayer’s Vitrakvi (larotrectinib)
Bayer	OrigiMed	Objective: Develop NGS-based companion diagnostic for cancer drug larotrectinib (Vitrakvi) for Chinese market
Mologic	BioSure	Objective: Develop SARS-CoV-2 antibody self-test Dynamic: Test to combine Mologic’s lateral flow assay with BioSure’s self-test design
CareDx	Weill Cornell Medicine	Objective: Develop urine-based gene expression test for acute cellular rejection in kidney transplant recipients called UroMap Dynamic: Multiyear exclusive research collaboration with Weill Cornell to have exclusive rights to provide UroMap, which is based on technology licensed from Cornell Medicine, to patients
Roswell Biotechnologies	Imec	Objective: Develop biosensor chips for use in molecular testing and DNA storage Dynamic: Key proof-of-concept work already successfully completed and products to become available in 2021
Avrobio	Saladax Biomedical	Objective: Develop automated nanoparticle immunoassay kit for busulfan therapeutic drug monitoring (TDM) Dynamic: Saladax developing a blood-based assay kit Avrobio to provide funding to support development of  assay, but Saladax to retain all product rights
Avacta	Adeptrix	Objective: Develop high-throughput COVID-19 antigen test Dynamic: Test to test that combine Avacta’s Affimer-based antigens that bind to the SARS-CoV-2 virus with Adeptrix’s bead-assisted mass spectrometry (BAMS) platform Avacta to receive royalty on Adeptrix’s sales of test kits
DISTRIBUTION, SALES & MARKETING AGREEMENTS
Property Owner	Distributor	Deal Summary
Veracyte	CareDx	Products: Solid organ transplant rejection tests on Veracyte’s nCounter Flex Analysis diagnostic platform Territory: Worldwide Exclusive
Ubiquitome	DiethelmKellerSiberHegner (DKSH)	Products: Ubiquitome’s Liberty 16 mobile PCR-based COVID-19 testing platform Liberty16 Territory: Australia, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, Thailand, Vietnam Exclusive
Chembio Diagnostics	Thermo Fisher Scientific	Products: Chembio’s DPP COVID-19 System Territory: US Non-exclusive
EKF Diagnostics	Tosoh Europe	Products: EKF’s point-of-care Quo-Test HbA1c analyzer Territory: Middle East and Africa 3-year deal
Sienna Cancer Diagnostics	Scientle Innovations	Products: Sienna’s hTERT test for bladder cancer Territory: New Zealand Exclusive
NG Biotech	Eurobio Scientific	Products: Eurobio’s NG Biotech's COVID-19 NG-Test IgG-IgM rapid serology test Territory: France
Osang Healthcare	SG Blocks	Products: Osang’s GeneFinder COVID-19 Plus RealAmp Kit Territory: US Non-exclusive, 1-year deal
Spartan Bio	Cardinal Health	Products: Spartan’s CYP2C19 assay Territory: US
Quest Diagnostics	Centene	Products: 25,000 Quest rRT-PCR-based SARS-CoV-2 test kits per week Territory: Federally Qualified Health Centers in 10 US states or districts
LICENSES
Licensor	Licensee	Deal Summary
Brigham and Women’s Hospital	Quanterix	Quanterix acquires non-exclusive rights to use SARS-CoV-2 serology test on its Simoa multiplex immunoassay platform
SUPPLY, SERVICE & TESTING AGREEMENTS
Supplier/Servicer	Client/User	Deal Summary
Quotient	Hvivo	Quotient to supply its SARS-CoV-2 antibody microarray test to UK-based contract research organization for use in viral challenge studies