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