DX Deals

New Saliva-Based Pregnancy Test May Revolutionize POC Diagnostics

The global pandemic has forced test makers to accelerate development of innovative rapid, point-of-care diagnostics. While COVID-19 detection remains the paramount objective, pandemic pressures may also lead to breakthroughs in other areas. One potential game changer could end up revolutionizing the kind of home test women who miss a period use to determine if they’re pregnant. Using COVID-19 detection technology to fertilize an idea gestated before the pandemic, Israeli medical start-up Salignostics is getting ready to launch the world’s first pregnancy test based on saliva samples.

The Untapped Potential of Saliva-Based Pregnancy Diagnostics

In addition to being easy to detect and store, saliva contains biomarkers that can be used for early detection of different diseases and medical conditions. The presence of multiple biomarkers makes saliva ideal for development of simple, noninvasive multiplexed assays that can be performed quickly at the point of care. One of the most promising of these biomarkers is beta-human chorionic gonadotropin (β-hCG), measurement of which can be used to detect levels of hormones associated with pregnancy. β-hCG levels in saliva are usually detectable at about three to four weeks into pregnancy and continue to increase as the pregnancy continues.
But despite its potential diagnostic advantages, there have been only a few studies evaluating the role of saliva and β-hCG as a noninvasive, rapid, and more acceptable biofluid for pregnancy detection. One study supporting the viability of using β-hCG levels in saliva to detect pregnancy was published in the journal Gynecology and Minimally Invasive Therapy in June 2019.

The New Saliva-Based Pregnancy Test

Perhaps encouraged by the GMIT study, Jerusalem-based Salignostics set out to use its proprietary saliva-based hormone detection technology to develop a home test for early pregnancy detection. Like so many other companies did when the pandemic arrived, Salignostics shelved its plans to concentrate on COVID-19 testing. But something unexpected happened along the way. In developing its SaliCov rapid antigen test for COVID-19, which has received CE Marking from the European Union (EU) and is now widely used across Europe and Africa, Salignostics uncovered the missing piece they needed to bring the pregnancy assay to fruition.

The company reports that its resulting SaliStick test product has 95 percent sensitivity when women use it after they have missed a period. The company has successfully completed clinical trials in Israel on more than 300 women—both pregnant and non-pregnant—and has begun the process of applying for CE Marking and US Food and Drug Administration (FDA) approval. If it all works out, the company plans call for a commercial launch early in 2022.

Here’s a summary of some of the key strategic diagnostic deals announced in November 2021:

STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1 Partner(s) 2+ Deal Summary
Burning Rock Biotech Merck
  • Objective: Develop companion diagnostic for MET inhibitor tepotinib (Tepmetko) in mainland China market
  • Dynamic: Leverage Burning Rock’s OncoCompass Target blood-based next-generation sequencing assay targeting 168 biomarkers, including MET
Burning Rock Biotech Impact Therapeutics
  • Objective: Furnish testing services to support Impact Therapeutics’ development of ATR inhibitor IMP9064 in China and US
  • Dynamic: Pharma firm’s most recent collaboration with Chinese genomics firms with Burning Rock to perform genetic testing of trial participants in its Guangzhou and California labs
Helix Cue Health
  • Objective: Generate SARS-CoV-2 sequencing data for study of individuals who test positive for virus with Cue Health’s at-home COVID-19 test
  • Dynamic: Positive subjects can opt into virus variant sequencing study by providing specimens for analysis with Helix research-use-only variant sequencing test with test results provided via the Cue Health App
Cellenion Bruker
  • Objective: Comarket tools for single-cell proteomics experiments
  • Dynamic: Market Cellenion’s CellenOne single-cell isolation and dispensing system with Bruker’s timsTOF SCP mass spectrometer to enable label-free single-cell proteomics workflows
Cellenion Thermo Fisher Scientific
  • Objective: Develop workflows for single-cell, mass spectrometry-based proteomics analyses
  • Dynamic: Comarketing agreement to combine combine Cellenion’s CellenOne single-cell isolation system and ProteoChip consumable with Thermo Fisher’s TMT multiplexing technologies and Orbitrap mass spectrometers
Lucence VA Palo Alto Health Care System
  • Objective: Launch observational study to evaluate use of sequencing-based LiquidHallmark liquid biopsy assay in a screening context
  • Dynamic: Study to compare study will compare the sensitivity and specificity of positron emission tomography-computed tomography (PET/CT), alone versus PET/CT in combination with LiquidHallmark in detecting lung cancer nodules between 6 and 20 millimeters
Genomenon Inozyme Pharma
  • Objective: Improve diagnosis and treatment of ENPP1 deficiency, aka, generalized arterial calcification of infancy or autosomal recessive hypophosphatemic rickets Type 2
  • Dynamic: Provide molecular diagnostic data on a rare pediatric-onset calcification disorder to testing labs and clinicians
Genomenon Deep 6 AI
  • Objective: Research cancer, Parkinson’s, Wilson’s disease and other diseases
  • Dynamic: Proof-of-concept agreement to explore integrating Deep 6 AI’s software for mining patient records, and genomics and pathology data to support trial-feasibility site selection and patient recruitment with Genomenon’s AI-powered Genomic Landscapes platform for matching patients to trial inclusion criteria
Genetron Health NeoGenomics
  • Objective: Support NeoGenomics’ drug development clinical trials
  • Dynamic: Use respective technology platforms and product pipelines to help business partners synchronize global clinical drug trials and companion diagnostics development
Scipher Medicine GNS Healthcare
  • Objective: Develop and launch Gemini, the in silico Patient, for rheumatoid arthritis
  • Dynamic: Patient model to use Scipher’s clinic-genomic patient data in RA generated from firm’s PrismRA liquid signature blood test to predict non-response to TNFi therapies in rheumatoid arthritis patients
Scipher Medicine Tara Biosystems
  • Objective: Identify therapeutic targets for drug development in cardiac laminopathies
  • Dynamic: Scipher to use its Spectra platform to identify potentially therapeutic targets from proteins up- and downstream of LMNA for a stratified disease population, while incorporating data from Tara’s Biowire II LMNA disease models
Saga Diagnostics AstraZeneca
  • Objective: Develop digital PCR assays for undisclosed methylated targets in tissue and liquid biopsies
  • Dynamic: Leverage Saga’s SagaSafe (formerly IBSafe) digital PCR method for improving sensitivity
Deep Bio Morphle Labs
  • Objective: Give pathologists access to AI-based prostate-specific tissue image analysis and Morphle Labs’ remote microscopy workflow scanner
  • Dynamic: Integrate Deep Bio’s DeepDx Prostate software with Morphle Labs’ slide scanners
Sciex Evosep
  • Objective: Comarket Sciex’s mass spectrometry with Evosep’s liquid chromatography systems for high-throughput proteomics workflows
  • Dynamic: Sciex to market its ZenoTOF 7600 mass spec system with Denmark-based Evosep’s Evosep One LC system
SomaLogic University Hospitals Cleveland Medical Center
  • Objective: Evaluate the impact of SomaLogic’s SomaSignal tests on managing diabetic patients at high risk of cardiovascular disease
  • Dynamic: Use test in clinical trials for identifying diabetic patients with elevated risk for cardiovascular disease and tracking effectiveness of therapies such as SGLT-2 inhibitors and GLP-1 agonists on those patients
Numares Oxford University Innovation
  • Objective: Develop multimarker test to detect multiple sclerosis disease progression
  • Dynamic: Exclusive license with Numares to develop MS biomarkers that identified by Oxford University into an in vitro diagnostic test

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner Distributor Deal Summary
PathogenDx Axiology Labs
  • Products: PathogenDx’s Detectx-Cv SARS-CoV-2 variant assay technology
  • Territory: Africa (12 countries), Thailand
Mission Bio Alliance Global
  • Products: Mission Bio’s single-cell sequencing Tapestri platform and other products
  • Territory: Middle East, Africa
  • Exclusive
Mission Bio Bioké
  • Products: Mission Bio’s single-cell sequencing Tapestri platform
  • Territory: Belgium, Netherlands, Luxembourg
PerkinElmer GenWorks Health
  • Products: PE’s newborn and prenatal screening products
  • Territory: India
  • Exclusive

LICENSES

Licensor Licensee Deal Summary
Spanish National Research Council (CSIC) World Health Organization and the Medicines Patent Pool (MPP) MPP licenses CSIC’s rapid manufacture and commercialization of COVID-19 antibody testing technology
University of Maryland, Baltimore + University of Maryland, Baltimore County RNA Disease Diagnostics RNA Disease Diagnostics licenses RNA-based lateral flow assay technology that for use to develop at-home molecular SARS-CoV-2 and influenza test kits

GOVERNMENT CONTRACTS

Contractor Govt. Agency Contract Summary
Quest Texas Department of State Health Services Quest to provide COVID-19 testing for K-12 schools in Texas via its labs in the Houston and Dallas-Fort Worth areas
Eurofins Genomics US US Department of the Air Force and Department of Health and Human Services $30 million contract to build a new production facility and to expand manufacturing capacity for reagents used in COVID-19 diagnostic tests
OraSure Technologies US Department of Defense $109 million contract for manufacturing scale-up for OraSure’s InteliSwab rapid SARS-CoV-2 antigen assays
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