Our Pipeline

Our mission

Bridging genomics and the environment to revolutionize the diagnosis and treatment of complex health conditions

A substantial need exists for new biomarkers, especially for Central Nervous System (CNS) conditions and Gastrointestinal (GI) disorders caused by the interplay of genetics and the environment. Extensive research in these areas has yet to result in genetic tests to guide diagnosis and treatment choices. Without biological tests, doctors continue to rely on questionnaires and specialists’ observations of symptoms for their clinical decision-making.

With its unique temporal exposomic platform, LinusBio can detect complex biomolecular signals in human hair. These signatures map metabolic responses to environmental inputs and can provide objective information to diagnose disease, stratify patient cohorts for clinical trials, and objectively measure study results.

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01

Central Nervous System

1001 - Early Autism Detection

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Status: CLIA Certificate of Compliance (COC) Acquired

ClearStrand-ASD ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) when it is a concern in children aged 1 month up to 36 months of age. It detects a biomarker associated with autism using a strand of hair. The test is performed by the LinusBio CLIA-certified laboratory (CLIA #31d2307499). 

02

Central Nervous System

10012 - Autism Detection (balanced device)

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: In development

StrandDx is the first molecular autism spectrum disorder (ASD) diagnostic biomarker. The test has received FDA Breakthrough designation. 

03

Central Nervous System

1002 - Attention Deficit Hyperactive Disorder (ADHD)

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Enrollment ongoing

Attention Deficit Hyperactive Disorder reduces people’s ability to focus, makes them more active and impulsive and is usually diagnosed through interviews and psychological tests. LinusBio’s diagnostic would be the first molecular test for ADHD, providing objective measures to aid in diagnosing patients and testing new therapies in clinical trials.

04

Central Nervous System

1003 - Psychosis & Schizophrenia

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Enrollment ongoing

Psychosis and schizophrenia can cause delusions, hallucinations, and other behavioral issues. There are effective therapies in the clinic, but the first step is diagnosis. At this moment, there are no molecular diagnostics for these conditions. 

05

Central Nervous System

1004 - Lou Gherig’s Disease (ALS)

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: FDA discussion initiated

Amyotrophic lateral sclerosis destroys the neurons that control muscle movement. As motor neurons die, muscles atrophy and weaken. Eventually, patients can no longer walk, talk or breath. ALS is currently diagnosed through multiple tests, with no definitive diagnostic. With a single strand of hair, LinusBio’s diagnostic platform can vastly accelerate and simplify the diagnostic process.

06

Gut

1005 - IBS, Eosinophilic Esophagitis, Microbiome

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Enrollment ongoing

IBS and eosinophilic esophagitis are chronic and painful conditions often caused by a person’s interactions with their environment. Exposomic readouts can help delineate underlying causes, providing a clinical strategy to help control these conditions.

07

Cancer

1006 - Pediatric Cancer

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Enrollment ongoing

Cancers respond best to treatment when they are detected early and that is particularly true for pediatric tumors. Exposomic data identifies the body’s response to malignancies, providing a roadmap for further care.

08

Data

1007 - Global Biodynamics Dataset

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: 1K complete, growing to 100K

Just like genomic information, which grows increasingly valuable as more gene variations and regulatory features are discovered, exposomic data gains value as it matures. LinusBio’s growing exposomic dataset is helping us develop a biomarker-based platform for multiple applications. 
In addition, biopharma companies can use this dataset to optimize clinical trial recruitment, set objective study endpoints, open new windows into patient compliance and drug pharmacology and solve many other problems.

09

Wellness

Wholistic Health

  • Patent
    submitted

  • Clinical
    studies

  • Pathway
    characterization

  • Commercially
    available

Status: Prototype complete for total analysis

People are often exposed to heavy metals, noxious gases and other toxins – both out in the world and in their own homes. LinusBio’s exposomic platform reads the body’s metabolic responses to these exposures, providing insights that could inform remediation, detoxification and other measures.

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Fast diagnostics in one assay

LinusBio’s platform generates data that would normally require hundreds of sequential blood tests – in one assay. These molecular signatures are being used to develop in-depth diagnostics for Autism Spectrum Disorder (ASD) and many other conditions.

Novel biomarkers and new health insights

Novel biomarkers deliver new angles on health and synergize with genomic and other diagnostic tests. These insights open new pathways for understanding health, enhancing diagnostics, and guiding more informed decision-making in medicine and wellness.

Objective biomarkers for early detection

The platform delivers objective biomarkers for Central Nervous System (CNS) disorders and other complex health conditions. Early detection often translates into more effective interventions.