What Biotheranostics does

Biotheranostics is a commercial-stage molecular diagnostics company headquartered in San Diego, California, that develops and operates proprietary gene-expression-based laboratory tests for oncology treatment decision-making. The company runs a CLIA-certified laboratory offering two flagship assays: the Breast Cancer Index (BCI), which is the only genomic test with dual recognition from both ASCO and NCCN Clinical Practice Guidelines for predicting benefit from extended endocrine therapy in hormone receptor-positive (HR+) early-stage breast cancer patients, and CancerTYPE ID, positioned as the most validated gene-expression assay for identifying tumor type and subtype in metastatic cancer patients presenting with unknown or unclear primary diagnoses. Both tests are deployed through a sales-led, direct-to-provider model in which oncologists, breast-cancer specialists, and pathologists order tests via the Hologic Provider Portal and patients interact with a separate payment portal (dxlink.com), with revenue generated through per-test laboratory service fees rather than disclosed subscription or enterprise contracts. Biotheranostics was acquired by Hologic, Inc. (NASDAQ: HOLX) in February 2021 and continues to operate as a wholly-owned subsidiary within Hologic's Diagnostics segment, with active clinical-evidence generation including 11 studies at the 2025 San Antonio Breast Cancer Symposium and a registry study presented at the 2026 ASCO Annual Meeting demonstrating material shifts in physician treatment recommendations following BCI testing.

Name

Biotheranostics

Legal name

Biotheranostics, Inc.

Website

https://biotheranostics.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

Biotheranostics is a San Diego-based, Hologic-owned molecular diagnostics company that operates a CLIA-certified lab providing two proprietary gene-expression tests — Breast Cancer Index and CancerTYPE ID — to oncologists for personalized treatment decisions in HR+ breast cancer and metastatic cancer of unknown primary.

Ownership category

akta.pro rank

Product category

Molecular Oncology Diagnostics

NAICS

Medical and Diagnostic Laboratories (62151), Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

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

akta.pro primary industry

Breast Oncology (HLAKAFAJ)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Proteomics & Biomarker Analytical Testing (HLAGADAG)

Keywords

• Molecular cancer diagnostics
• Genomic oncology testing
• Breast cancer assays
• Tumor profiling services
• Gene expression diagnostics

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Testing Services: Biotheranostics provides genomic testing services to healthcare providers and patients, generating revenue through laboratory service fees for the Breast Cancer Index and CancerTYPE ID tests

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Biotheranostics operates a CLIA-certified laboratory that provides two proprietary gene expression-based genomic tests to support oncologists' treatment decisions. The Breast Cancer Index (BCI) test predicts benefit of extended endocrine therapy in hormone receptor-positive (HR+) early-stage breast cancer patients, while the CancerTYPE ID assay identifies tumor type and subtype in metastatic cancer patients with unknown or unclear diagnoses.

Product overview

Biotheranostics offers a portfolio of proprietary genomic assays for personalized disease management in oncology. The company provides two core genomic tests: the Breast Cancer Index (BCI) test for predicting extended endocrine therapy benefit in HR+ early-stage breast cancer, and the CancerTYPE ID assay for identifying tumor types and subtypes in metastatic cancer patients with unknown diagnoses. Both products use gene expression analysis to guide treatment decisions. Biotheranostics was acquired by Hologic in February 2021.

Differentiator

Problem solved

Functional benefit

Brands

• Breast Cancer Index: The only genomic test recognized by ASCO and NCCN Clinical Practice Guidelines to help predict benefit of extended endocrine therapy in HR+, early-stage breast cancer.
• CancerTYPE ID

Products and services

• Breast Cancer Index (BCI) A proprietary gene expression-based genomic test recognized by both ASCO and NCCN Clinical Practice Guidelines that helps predict benefit of extended endocrine therapy in hormone receptor-positive (HR+), early-stage breast cancer patients. Used by oncologists and breast cancer specialists to personalize treatment duration decisions.
• CancerTYPE ID A proprietary gene expression-based assay described as the most validated of its kind that helps identify the tumor type and subtype for metastatic cancer patients with unknown or unclear diagnoses, supporting personalized treatment selection by oncologists and pathologists.

Quantifiable outcome

• Physician recommendations for extended endocrine therapy increased by over 30% for patients identified as likely to benefit following BCI testing
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• HologiccoreStrategic or Co-development Partner · 1 February 2021Hologic acquired Biotheranostics in February 2021. Biotheranostics continues to operate as a subsidiary offering its portfolio of proprietary genomic assays for personalized disease management in oncology, leveraging Hologic's broader diagnostics infrastructure and market presence.

Scale indicators3 records

Recent moves4 records

Expansion highlights3 records

Direct peers

• Myriad Genetics: Myriad Genetics offers hereditary cancer testing (BRACAnalysis) and oncology molecular diagnostics, competing in similar oncology specialist channels and serving overlapping breast and metastatic cancer patient populations.
• Veracyte: Veracyte (including the NanoString Prosigna acquisition) markets the Prosigna Breast Cancer Prognostic Gene Signature Assay, a direct competitor to BCI for HR+ early-stage breast cancer risk of recurrence assessment.
• Exact Sciences: Exact Sciences develops and commercializes the Oncotype DX Breast Recurrence Score test, the most entrenched competitor to Biotheranostics' Breast Cancer Index for guiding extended endocrine therapy decisions in HR+ early-stage breast cancer.
• Agendia: Agendia offers MammaPrint and BluePrint genomic assays for breast cancer recurrence risk and molecular subtyping, directly competing with Biotheranostics' BCI in the same oncologist customer base for early-stage breast cancer treatment decisions.
• Caris Life Sciences: Caris provides molecular profiling and tumor type identification services for metastatic and cancers of unknown primary, directly overlapping with CancerTYPE ID's use case for oncologists dealing with unclear diagnoses.

Broad incumbents

• Foundation Medicine (Roche): Foundation Medicine, a Roche subsidiary, provides comprehensive genomic profiling for solid tumors including FoundationOne CDx, overlapping with Biotheranostics' CancerTYPE ID for metastatic cancer molecular profiling and tumor characterization.
• NeoGenomics: NeoGenomics is a clinical oncology laboratory offering comprehensive oncology testing services including molecular and genetic profiling, competing broadly with Biotheranostics' specialty genomic assays while serving a wider oncology menu.

Emerging players

• Natera: Natera offers oncology molecular testing including Signatera for MRD monitoring and broader tumor profiling, competing in the oncology molecular diagnostics space where Biotheranostics operates.
• Guardant Health: Guardant Health offers liquid biopsy-based oncology testing including tumor profiling for advanced cancers, representing an emerging technology approach that competes with tissue-based assays like CancerTYPE ID and could encroach on BCI's market.
• Tempus AI: Tempus provides multi-modal oncology testing including molecular profiling and tumor type identification for metastatic cancer, competing with CancerTYPE ID for cancer of unknown primary workups.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds1 record

Investors3 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 Biotheranostics