Linus Biotechnology

What Linus Biotechnology does

Linus Biotechnology, Inc. (LinusBio) is a US-based precision exposome medicine company that operates a proprietary temporal exposome sequencing platform. Founded in 2020 as a spinout from the Icahn School of Medicine at Mount Sinai, the company uses automated robotics, laser ablation, mass spectrometry, and an AI pipeline to analyze single hair strands and generate approximately 150 million biochemical data points — equivalent to over 500 liquid biopsies — that map an individual's biological response to environmental exposures across time.

The company monetizes this platform through prescription-based diagnostic testing, clinical-trial services for pharmaceutical companies, and academic/research collaborations. ClearStrand-ASD, commercially launched in February 2025, is a non-invasive rule-out test for autism spectrum disorder in children 1 month to 10 years of age, performed in LinusBio's CLIA-certified laboratory. StrandDx-ASD, a related diagnostic aid with FDA Breakthrough Device designation, covers ages from birth to 21 years. The platform also supports a Global Biodynamics Dataset and pipeline programs in ADHD, ALS, schizophrenia, IBS, and pediatric cancer.

LinusBio distributes ClearStrand-ASD primarily through licensed healthcare providers with telehealth-enabled ordering, expanded through partnerships with Autism Speaks, the BRAIN Foundation, and Coralis Health. The test is available in 49 US states (as of March 2026) and in Japan through an exclusive distribution agreement with YAC Bio (Y.A.C. Holdings), representing the company's first international market. The company has raised over $25.5 million in funding, led by GreatPoint Ventures, Bow Capital, Divergent Investments, and Y.A.C. Holdings, and is led by founder and CEO Dr. Manish Arora.

Name

Linus Biotechnology

Legal name

Linus Biotechnology, Inc.

Website

https://linusbio.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

LinusBio is a US precision medicine company that uses AI-driven temporal exposomic sequencing of hair strands to diagnose autism (ClearStrand-ASD) and develop biomarkers for CNS, GI, and oncology conditions, serving families, pediatricians, and pharmaceutical trial sponsors.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO)

akta.pro secondary industries

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Exposome sequencing platform
• Molecular diagnostics
• Biomarker discovery services
• Autism diagnostic testing
• Precision exposome medicine

Headquarters

HQ city

New Rochelle

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Diagnostic Testing Services: ClearStrand-ASD is sold as a biochemical diagnostic test. The test is ordered by licensed healthcare providers (Rx only) and performed in LinusBio's CLIA-certified laboratory. Caregivers can request the test through an independent telehealth provider.
2. Clinical Trial Services for Pharma: Provides molecular data, objective endpoints, and screening tools for pharmaceutical companies conducting clinical trials. The platform helps enroll appropriate clinical trial cohorts, measure patient compliance, and provide longitudinal environmental exposure data.
3. Research Platform Licensing: Platform is used in academic collaborations and pharmaceutical research. The BRAIN Foundation facilitates academic collaborations for researchers to incorporate LinusBio's temporal exposome sequencing platform into their studies.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels9 records

Core offering

LinusBio develops and commercializes a proprietary Temporal Exposome Sequencing Platform that analyzes a single strand of hair using robotics, laser ablation, mass spectrometry, and AI/ML to detect molecular biomarkers. Its commercial product is ClearStrand-ASD, a prescription diagnostic aid that helps healthcare providers rule out autism spectrum disorder in children from 1 month to 10 years of age. The platform is also licensed to pharmaceutical and academic clients for clinical trial endpoints, biomarker discovery, and research.

Product overview

LinusBio is a precision exposome medicine company offering a platform-plus-products architecture. The core technology is a temporal exposome sequencing platform that analyzes hair strands using proprietary robotics, laser ablation, mass spectrometry, and AI to identify molecular biomarkers. The primary commercial product is ClearStrand-ASD, a biochemical test for ruling out autism spectrum disorder in children from 1 month to 10 years of age. StrandDx-ASD is the diagnostic aid counterpart with FDA Breakthrough Designation that assesses ASD likelihood. The platform also generates a Global Biodynamics Dataset and is being applied to develop diagnostics for ADHD, ALS, schizophrenia, IBS, and pediatric cancer.

Differentiator

Problem solved

Functional benefit

Brands

• ClearStrand-ASD: First-of-its-kind biochemical test intended to help healthcare providers rule out autism spectrum disorder (ASD) in children using a strand of hair. Available by prescription in 49 states and internationally in Japan.
• StrandDx-ASD

Products and services

• ClearStrand-ASD A non-invasive, prescription-only biochemical diagnostic test that uses a single strand of hair to help healthcare providers rule out autism spectrum disorder in children 1 month to 10 years of age. Performed in LinusBio's CLIA-certified laboratory.
• StrandDx-ASD First molecular autism spectrum disorder diagnostic biomarker with FDA Breakthrough Device designation; intended to assess likelihood of ASD in children from birth to 18 months and aid in diagnosis for patients 18 months to 21 years. Developed as a laboratory developed test (LDT) using a single strand of hair.
• Temporal Exposome Sequencing Platform (Clinical Trial & Research Services) Proprietary biomarker platform that maps growth rings in hair to reveal molecular features at multiple time points using robotics, laser ablation, mass spectrometry, and AI. Licensed and sold as a service to pharmaceutical companies for clinical trial endpoints, patient stratification, compliance measurement, and exposure data, and to academic researchers for biomarker discovery studies.

Quantifiable outcome

• 80-90% accuracy in detecting autism biomarker at birth
• +5 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature7 records

Partnerships

Six partnerships are on record, tiered core and major.

• Coralis HealthcoreStrategic or Co-development Partner · 5 August 2025Partnership to reduce autism diagnosis waitlists. Combines ClearStrand-ASD biomarker test with Coralis Health's specialized care platform, creating a seamless pathway from early screening to diagnosis and intervention. Reduces typical years-long diagnostic journey to just 90 days. Families with ClearStrand results are referred to Coralis Health, with virtual diagnostic teams reaching out within 5 calendar days.
• Autism SpeakscoreStrategic or Co-development Partner · 17 April 2025Partnership to advance early autism diagnosis and intervention. Autism Speaks provides educational materials and resources through their Autism Response Team (ART), helping families understand biomarker testing. Autism Speaks offers ClearStrand-ASD at reduced cost to families in need. LinusBio supports Autism Speaks' community initiatives including the Empower Summit & Challenge events in five U.S. cities.
• The BRAIN FoundationmajorStrategic or Co-development Partner · 2 April 2025Partnership to support autism biomarker research and facilitate early identification and intervention. BRAIN Foundation facilitates academic collaborations for researchers to incorporate LinusBio's platform into studies. LinusBio provides discounted ClearStrand-ASD testing for BRAIN community members. Both organizations work to remove barriers for early intervention and increase awareness about novel biomarkers. LinusBio's first collaboration with a patient advocacy group.
• Novozymes / Novozymes OneHealthmajorStrategic or Co-development Partner · 11 November 2022Collaboration to test LinusBio's environmental biodynamics platform in a clinical trial. The project applies temporal mapping of harmful compound exposure (lead and environmental pollutants) to a clinical trial of probiotics sponsored by Novozymes OneHealth. Study conducted in Mexico where lead exposure is a significant public health issue. Collaboration combines exposome data with Novozymes' Data Science platform.
• Mount Sinai Health SystemcoreStrategic or Co-development Partner · 21 November 2021LinusBio spun off from Mount Sinai with a worldwide license and collaboration agreement. The company's technology is based on research developed by Dr. Manish Arora and other faculty at Icahn School of Medicine at Mount Sinai. Mount Sinai researchers including Dr. Arora have a financial interest in LinusBio.
• The BRAIN FoundationcoreStrategic or Co-development PartnerPartnership for biomarker-supported autism diagnosis and early intervention research. Company to offer reduced-cost testing for at-risk patients and their families. BRAIN Foundation facilitates academic collaborations for researchers to incorporate LinusBio's temporal exposome sequencing platform.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Quadrant Biosciences: Quadrant Biosciences develops saliva-based molecular diagnostic tests for autism spectrum disorder and other neurological conditions, making it the most direct competitor to LinusBio's ClearStrand-ASD in non-invasive autism biomarker testing.
• Metabolon: Metabolon provides metabolomics-based biomarker discovery and clinical research services with mass spectrometry platforms; directly comparable technology approach for exposomic/molecular biomarker development and clinical trial support.

Broad incumbents

• Tempus Labs: Tempus is an AI-driven precision medicine company offering molecular diagnostics, multi-omics data, and clinical trial support services; comparable to LinusBio in combining AI/ML with molecular data for biomarker discovery and clinical trial applications.
• Myriad Genetics: Myriad Genetics is an established molecular diagnostics company offering genetic tests for hereditary cancers and other conditions; comparable as a CLIA-certified lab business model selling diagnostic tests to healthcare providers.
• Natera: Natera specializes in molecular diagnostics for oncology, reproductive health, and organ transplantation using cell-free DNA analysis; comparable CLIA-certified lab offering specialty molecular tests ordered through healthcare providers.
• GeneDx: GeneDx (formerly Sema4) is a genomics and molecular diagnostics company offering whole exome sequencing and genetic tests, including for autism diagnosis; competing in the autism diagnostic workup pathway where LinusBio positions ClearStrand-ASD.
• NeoGenomics: NeoGenomics is a CLIA-certified oncology-focused molecular diagnostics company with pharma services and clinical trial testing; comparable lab services business model with pharma B2B and healthcare provider channels.
• Foundation Medicine (Roche): Foundation Medicine is a leading molecular diagnostics company specializing in comprehensive genomic profiling for cancer; comparable in AI-driven interpretation of complex molecular data and pharma partnership model for clinical trials.
• Roche Diagnostics: Roche Diagnostics is the largest in vitro diagnostics company globally, offering molecular diagnostic tests, lab automation, and companion diagnostics; represents a potential partner or acquirer and operates in the same molecular diagnostics category.
• PerkinElmer (Revvity): PerkinElmer (now Revvity) provides diagnostics, life sciences, and analytical instruments including newborn screening and molecular diagnostics; comparable in providing both diagnostic tests and the laboratory instruments/informatics infrastructure underlying them.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/linusbio
• Xx.com/linusbio

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds4 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Linus Biotechnology