Breast Cancer Index

What Breast Cancer Index does

Breast Cancer Index (BCI) is a proprietary molecular diagnostic brand operated by Biotheranostics, Inc., a wholly-owned subsidiary of Hologic, Inc. (NASDAQ: HOLX). The company's core product is a laboratory-developed genomic test that analyzes gene expression from tumor tissue to deliver two outputs: a binary predictive answer (YES/NO) on whether a patient is likely to benefit from extending anti-estrogen therapy beyond five years, and an individualized prognostic risk estimate of late distant recurrence between years five and ten post-diagnosis. The test is indicated for women with early-stage, hormone receptor-positive (HR+) breast cancer who are lymph node-negative or have up to three positive nodes, and it uses the patient's existing tumor sample, requiring no additional procedures.

The technology has been validated across multiple peer-reviewed studies and is recognized in the NCCN Clinical Practice Guidelines for Breast Cancer (V.5.2025) and the ASCO Clinical Practice Guideline on Biomarkers for Adjuvant Endocrine and Chemotherapy as the only genomic test for predicting extended endocrine therapy benefit. Biotheranostics operates a CLIA-certified, high-complexity clinical laboratory in San Diego, California. The test is not FDA-cleared or approved, but is positioned as a clinical-use LDT with Medicare reimbursement under LCD ID 37822 (no patient copay when criteria are met) and commercial insurance coverage pathways.

Commercially, Breast Cancer Index operates a sales-led, healthcare-provider-driven distribution model: the test can only be ordered by a licensed US provider with a valid NPI, and Biotheranostics coordinates tumor-sample retrieval directly with the originating pathology lab. Revenue is generated on a per-test basis through insurance reimbursement, supported by a patient services team that handles billing, insurance verification, and financial assistance (available when expected out-of-pocket costs exceed $100). Patient acquisition is driven through content marketing, YouTube testimonials, multilingual conversation guides, and provider-channel integration via Hologic.com. Outcomes data from Sanft et al. 2025 show that 45% of patients changed their therapy preference, 41% felt more comfortable with their decision, and 40% of providers changed their recommendations after receiving BCI results.

Name

Breast Cancer Index

Legal name

Biotheranostics, Inc.

Website

https://breastcancerindex.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

Breast Cancer Index is a genomic laboratory-developed test operated by Biotheranostics, Inc. (a Hologic subsidiary) that analyzes gene expression from tumor samples to guide anti-estrogen therapy duration decisions for women with early-stage hormone receptor-positive breast cancer in the United States.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Genetic & Prenatal Testing Laboratories (HLAFAMAH)

akta.pro secondary industry

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

Keywords

• Genomic diagnostic testing
• Breast cancer diagnostics
• Oncology genomic assays
• Recurrence risk profiling
• Endocrine therapy planning

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, Others

Revenue model

1. Laboratory Testing Services: The Breast Cancer Index Test is a laboratory-developed test performed by Biotheranostics, Inc. Revenue is generated through insurance reimbursement from Medicare and commercial payers. Medicare covers the test with no copay or deductible when criteria are met. Commercial insurance may also cover the test.
2. Financial Assistance Program: For patients with expected out-of-pocket costs exceeding $100, patient services team contacts patients to discuss billing process and financial assistance options.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

The Breast Cancer Index (BCI) Test is a proprietary laboratory-developed genomic test that analyzes gene expression from a patient's existing tumor sample to deliver two results: (1) a predictive YES/NO answer on whether continuing anti-estrogen therapy beyond five years is likely to reduce recurrence risk, and (2) an individualized prognostic percent risk of late distant recurrence between years 5–10. The test is performed by Biotheranostics, Inc.'s CLIA-certified laboratory and is ordered exclusively by licensed healthcare providers.

Product overview

Breast Cancer Index is a single genomic test offering (BCI Test) that provides both predictive and prognostic information for early-stage hormone receptor-positive breast cancer patients. The test combines two results: a predictive answer ('yes' or 'no') on whether extended anti-estrogen therapy is likely to reduce recurrence risk, and a prognostic estimate of the patient's individualized risk of late distant recurrence. The test requires a healthcare provider order and does not require any additional procedures from the patient—Biotheranostics retrieves the tumor sample from the original biopsy or surgery pathology lab.

Differentiator

Problem solved

Functional benefit

Brands

• BCI Test: The Breast Cancer Index (BCI) Test provides personalized information to help determine the optimal length of anti-estrogen therapy for breast cancer patients. It provides a predictive result (yes/no) on whether continuing therapy beyond 5 years is likely to benefit the patient and an individualized risk of late distant recurrence between years 5-10.

Products and services

• Breast Cancer Index (BCI) Test A laboratory-developed genomic test that analyzes gene expression from a tumor sample to provide early-stage hormone receptor-positive breast cancer patients and their oncologists with a predictive YES/NO result on benefit from extended (>5 year) anti-estrogen therapy, plus an individualized prognostic percent risk of late distant recurrence (years 5–10). Indicated for women with HR+, node-negative or 1–3 node-positive early-stage invasive breast cancer who are distant recurrence-free.
• Patient Services and Financial Assistance Program Companion patient-support service providing phone/email assistance for BCI Test inquiries, insurance verification, billing questions, and financial assistance enrollment for eligible patients.

Quantifiable outcome

• 45% of patients changed their preference regarding extended anti-estrogen therapy following BCI Testing
• +3 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature3 records

Partnerships

One partnership is on record.

• Hologic, Inc.coreOEM/ Whitelabel/ Licensing PartnerBiotheranostics, Inc. is a wholly-owned subsidiary of Hologic, Inc. The Breast Cancer Index Test is marketed through both breastcancerindex.com (patient site) and Hologic.com (provider site). Hologic provides the corporate infrastructure, compliance framework, and distribution channel for the BCI Test.

Scale indicators5 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Myriad Genetics: Myriad is a longstanding molecular diagnostics incumbent with a hereditary cancer testing franchise (BRACAnalysis, myRisk) that overlaps with the breast cancer patient journey. It is a broad incumbent because it serves the same oncology ecosystem with a broader portfolio (germline + select somatic tests) rather than a single narrow indication like BCI.
• Hologic, Inc. Hologic is the parent company of Biotheranostics and owner of the BCI brand, with a broader women's health and diagnostics portfolio including ThinPrep cytology, Genius digital cytology, and breast health screening. It is a broad incumbent because BCI sits inside a much larger diversified diagnostics organization whose corporate strategy and capital allocation directly govern BCI's trajectory.
• NeoGenomics: NeoGenomics operates a large oncology-focused clinical laboratory offering a broad menu of solid-tumor genomic profiling, hematology, and PD-L1 tests used by oncologists. It is a broad incumbent because it competes for the same hospital/community oncology customer wallet via a multi-test menu, of which breast cancer genomic testing is one component.

Direct peers

• Prosigna (Veracyte): Veracyte's Prosigna is a gene expression test using the PAM50 algorithm to assess risk of recurrence and intrinsic subtype in postmenopausal HR+ breast cancer. It is a direct peer because it performs gene-expression-based risk profiling on the same patient population and competes for NCCN guideline status and oncologist ordering decisions in extended endocrine therapy planning.
• MammaPrint (Agendia): Agendia's MammaPrint is an FDA-cleared 70-gene expression assay that provides recurrence risk and molecular subtyping for early-stage breast cancer. It is a direct peer because both MammaPrint and BCI analyze tumor tissue gene expression to inform adjuvant/extended endocrine therapy decisions in the same HR+ patient population, and both compete for inclusion in NCCN/ASCO guidelines.
• Oncotype DX (Exact Sciences): Exact Sciences acquired Genomic Health in 2019 to obtain the Oncotype DX breast cancer recurrence score, the most widely used genomic test for early-stage HR+ breast cancer. It is a direct peer because both tests use gene expression from tumor tissue to guide adjuvant therapy decisions in the same patient population, competing for oncologist mindshare and Medicare coverage.

Emerging players

• Guardant Health: Guardant Health is best known for liquid biopsy tests (Guardant360, Reveal) but is expanding into earlier-stage and minimal residual disease settings that could eventually overlap with BCI's recurrence-risk territory. It is an emerging player because its current MRD/early-stage evidence base is thinner than BCI's, but its technology platform could compete in late-recurrence risk prediction over time.
• Caris Life Sciences: Caris offers MI Profile and other molecular profiling services used by oncologists for solid tumor molecular characterization, including breast cancer. It is an emerging player because it is broadening into comprehensive multi-omics profiling that could eventually offer predictive insights into extended endocrine therapy benefit, overlapping with BCI's clinical-decision value proposition.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/BreastCancerNDX
• Facebookfacebook.com/breastcancerindex
• LinkedInlinkedin.com/company/breastcancerindex

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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 Breast Cancer Index