Astute Medical

What Astute Medical does

Astute Medical is a privately-held, for-profit diagnostics company founded in 2007 and headquartered in San Diego, California. The firm focuses on the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers, an area where it has built proprietary assay and clinical-validation IP over roughly two decades. The company operates at a commercial scale of 51–100 employees, consistent with a late-stage clinical diagnostics organization that has progressed from discovery into early hospital adoption. Its scientific leadership is anchored by co-founder and Chief Scientific Officer Paul McPherson, who remains on the board.

Astute Medical has funded its development through nine disclosed financing rounds between 2008 and 2016, raising approximately $206 million in cumulative capital. Early rounds (2008–2011) totaled approximately $45.75 million from venture investors DeNovo Ventures, Delphi Ventures, Domain Associates, and Johnson & Johnson Development Corporation. The 2012 Series 3 ($40.4 million) broadened the syndicate to include MPM Capital as lead, Kaiser Permanente Ventures, and the prior participants. Subsequent rounds added growth capital: $40 million from CRG (Oct 2014), $20 million from Fosun Pharma (Oct 2015), and a $43 million round from Bio-Techne (Dec 2016) — the company's largest single disclosed financing.

The commercial model centers on biomarker-based diagnostic tests sold primarily into hospital and clinical laboratory channels, with usage-based revenue from test kits and consumables running on installed instruments, alongside enterprise sales contracts. The investor mix — including a global pharmaceutical platform (Fosun Pharma), a healthcare growth capital specialist (CRG), a publicly-traded life-sciences tools company (Bio-Techne), and integrated delivery-system capital (Kaiser Permanente Ventures) — signals a deliberate build-out of both scientific validation and commercial scaling capability, with an apparent eye toward international (notably Asia-Pacific) expansion following the Fosun investment.

Name

Astute Medical

Website

https://astutemedical.com

Company type

Private

Founded year

2007

Headcount range

51–100 employees

Short description

Astute Medical, founded in 2007 in San Diego, is a private protein biomarker diagnostics company developing and commercializing tests for high-risk medical conditions such as acute kidney injury, selling primarily into hospital and clinical laboratory channels.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

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

SIC

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

akta.pro primary industry

Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Protein biomarker diagnostics
• Acute kidney injury testing
• In vitro diagnostic assays
• Biomarker validation services
• Risk stratification diagnostics

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Instruments and Systems: Sale and installation of diagnostic instrumentation including BIOFIRE systems, VITEK MS, BACT/ALERT systems. Instruments provide recurring revenue through consumables.
2. Diagnostic Test Kits and Consumables: Recurring sales of test kits, reagents, and consumables for installed instrument base. Includes specialty panels for sepsis, respiratory, gastrointestinal, and food safety applications.
3. Pharmaceutical Quality Control Testing: Solutions for sterility testing, endotoxin testing, mycoplasma testing, and environmental monitoring for pharmaceutical and biopharmaceutical manufacturers.
4. Service and Support Contracts: Technical support, maintenance, calibration, and customer service agreements for diagnostic systems.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Astute Medical provides diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers. The company develops and commercializes protein biomarker-based in vitro diagnostic tests designed to enable clinicians and clinical laboratories to detect and assess risk for critical medical conditions, with focus areas including acute kidney injury (AKI) risk assessment.

Product overview

bioMérieux offers a comprehensive portfolio of in vitro diagnostic solutions spanning clinical diagnostics, food safety testing, and pharmaceutical quality control. The core platform consists of molecular diagnostic systems (BIOFIRE® FILMARRAY® TORCH and BIOFIRE® SPOTFIRE®), microbial detection systems (BACT/ALERT® VIRTUO® and BACT/ALERT® 3D), mass spectrometry (VITEK® MS PRIME), and immunoassay solutions (VIDAS®). These are complemented by specialized panels and modules (respiratory, gastrointestinal, mycoplasma) and food industry products (GENE-UP®, VERIFLOW™, TEMPO®, 3P® ENTERPRISE). The portfolio integrates multiplex PCR technology, MALDI-TOF mass spectrometry, and automated microbial detection to address infectious disease diagnostics, antimicrobial stewardship, sepsis management, and food safety applications.

Differentiator

Problem solved

Functional benefit

Products and services

• Protein Biomarker Diagnostic Tests In vitro diagnostic tests built on identified and validated protein biomarkers, used by hospitals and clinical laboratories to diagnose high-risk medical conditions.
• Acute Kidney Injury (AKI) Risk Assessment Tests Diagnostic tests enabling clinicians to identify patients at risk of acute kidney injury through protein biomarker-based assessment, supporting early clinical intervention in critical care settings.

Quantifiable outcome

• BIOFIRE SPOTFIRE Vaginitis Panel provides results in 20 minutes
• +2 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Antimicrobial Stewardship Centers of ExcellencecoreStrategic or Co-development PartnerA network of pioneering institutions engaged in the global initiative of strengthening antimicrobial stewardship and diagnostic-driven care. The Centers of Excellence bring together healthcare leaders to advance the fight against antimicrobial resistance (AMR), with bioMérieux partnering to provide diagnostic expertise and solutions supporting appropriate antibiotic therapy decisions.

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• bioMérieux: Global IVD leader with a portfolio that includes protein biomarker tests for critical-care conditions (sepsis, PCT-guided antibiotic therapy) and an installed base in hospital and clinical laboratories. Directly comparable to Astute Medical's protein biomarker diagnostics for high-risk medical conditions and shares similar hospital/critical-care customers.
• Sphingotec (Revvity): German biomarker company developing and commercializing protein biomarkers for acute and critical-care conditions (e.g., AKI, cardiovascular risk). Directly comparable to Astute Medical as a focused protein biomarker diagnostics peer in the same high-risk medical condition space.

Broad incumbents

• Roche Diagnostics: One of the largest global IVD players with extensive menus in clinical chemistry, immunoassays, and biomarker-based diagnostics across hospital and reference-lab channels. Competes with Astute in high-acuity protein biomarker testing through its Elecsys/Cobas platforms.
• Siemens Healthineers: Large IVD and imaging player with an ADVIA Centaur / Atellica immunoassay menu covering cardiac, sepsis, and acute-care biomarkers. Directly comparable to Astute in critical-care hospital diagnostics, with broader portfolio reach.
• Beckman Coulter (Danaher): Clinical diagnostics franchise under Danaher offering Access / DxI immunoassay systems used by hospital laboratories for protein biomarker testing. Competes with Astute for the same hospital lab testing budgets and workflow integrations.
• DiaSorin: Italian specialty IVD company with a strong LIAISON immunoassay franchise covering infectious disease, cardiac, and critical-care biomarkers. Comparable to Astute in protein biomarker-based diagnostics for hospital laboratories.
• Ortho Clinical Diagnostics: Specialty IVD company (now under QuidelOrtho) offering VITROS immunoassay systems used by hospital labs for protein biomarker testing. A direct comparator for Astute's hospital-focused diagnostic testing footprint.
• QuidelOrtho: Specialty diagnostics company with rapid immunoassay and biomarker products serving hospitals and reference labs. Comparable to Astute's protein biomarker diagnostics for high-risk medical conditions through its specialty IVD focus.
• Abbott Diagnostics: Major diversified diagnostics franchise (ARCHITECT, Alinity platforms) offering immunoassays and protein biomarker tests relevant to critical-care and hospital customers. A scaled competitor that Astute would compete with for hospital formulary slots and clinical adoption.

Others

• Bio-Techne: Life-science tools and diagnostics company that led Astute's 2016 financing round and is closely tied to its biomarker strategy. Comparable as a strategic investor and potential commercial partner/parent with overlapping biomarker and protein research reagent offerings.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/astute-medical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds9 records

Investors9 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 Astute Medical