Precision BioLogic

What Precision BioLogic does

Precision BioLogic Incorporated is a Nova Scotia, Canada-based developer and manufacturer of frozen diagnostic products used by clinical hemostasis and coagulation laboratories. Founded in 1992 and headquartered in Dartmouth, the company sells its CRYOcheck line of controls, specialty plasmas, factor deficient plasmas, reagents, and diagnostic kits to clinical laboratories performing routine coagulation testing, hemophilia management, lupus anticoagulant detection, and thrombophilia screening. Products are sold in frozen format to eliminate reconstitution errors, with extended shelf life of two to three years, color-coded compact packaging, and platform-independent performance on automated coagulation analyzers. The portfolio includes the first FDA-cleared chromogenic Factor VIII assay for automated instruments (launched 2020) and an updated bovine formulation cleared in 2025 for monitoring emerging FVIIIa mimetic bispecific antibody therapies.

The company operates a hybrid commercial model: direct sales and customer support within North America combined with a network of specialized distributors covering 14+ European countries plus Australia, New Zealand, Korea, Japan, and Taiwan. The company holds FDA 510(k) clearances, ISO 13485:2016 certification, MDSAP certification, and IVDR QMS certification (obtained June 2023), collectively enabling access to the US, EU, Japan, Canada, and Australian markets. Precision BioLogic has expanded through two acquisitions: Affinity Biologicals (November 2018), adding coagulation-related antibodies and ELISA kits for research and diagnostics, and George King Bio-Medical, Inc. (October 16, 2025), adding specialty fresh frozen human plasma products with ties to the bleeding disorders community. The company was acquired by private equity firm Procuritas Capital Investors VII in February 2024. Pricing is quote-based per unit/vial, with no public price list; revenue is not publicly disclosed.

Name

Precision BioLogic

Legal name

Precision BioLogic Incorporated

Website

https://precisionbiologic.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

11–50 employees

Short description

Precision BioLogic develops and manufactures frozen diagnostic controls, reagents, and chromogenic assays for clinical hemostasis and coagulation laboratories in North America, Europe, Asia-Pacific, and Oceania. Owned by Procuritas Capital Investors VII since February 2024.

Ownership category

akta.pro rank

Product category

Hemostasis Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Hematology & Coagulation Diagnostics (HLAHAAAB)

akta.pro secondary industry

Plasma-Derived Therapy Cold Chain & Specialty Logistics (HLAIAHAL)

Keywords

• Hemostasis diagnostics
• Coagulation testing products
• Frozen diagnostic reagents
• Clinical laboratory controls
• In vitro diagnostics

Headquarters

HQ city

Dartmouth

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Products Sales: Precision BioLogic develops, manufactures, and markets frozen diagnostic products for hemostasis labs. Revenue comes from sale of controls, specialty plasmas, reagents, and diagnostic kits to clinical laboratories.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

Precision BioLogic develops, manufactures, and markets frozen diagnostic products under the CRYOcheck brand for clinical hemostasis laboratories. The portfolio includes controls, specialty plasmas, factor deficient plasmas, reagents, and diagnostic kits used by clinical laboratories to perform coagulation testing for the diagnosis and monitoring of blood coagulation disorders such as hemophilia, lupus anticoagulant, thrombophilia, and heparin therapy. Products are sold frozen, eliminating reconstitution errors and providing extended shelf life of two to three years.

Product overview

Precision BioLogic is a developer and manufacturer of frozen hemostasis diagnostic products under the CRYO*check* brand. The company's product portfolio comprises four main categories: Controls & Specialty Plasmas (including Abnormal Controls, Reference Plasmas, Lupus Controls, Heparin Control, and Pooled Normal Plasma); Factor Deficient Plasmas (Factor II, V, VII, VIII, VIII with VWF, IX, X, XI, XII, and Prekallikrein); Diagnostic Kits (Chromogenic Factor VIII and IX assays, Clot C, Factor VIII Inhibitor Kit, Hex LA); and Reagents (LA Check, LA Sure, Platelet Lysate). All products are designed for use with automated coagulation analyzers in clinical hemostasis laboratories. The company operates an online ordering system and customer portal for lot-specific documentation. Precision BioLogic has expanded through two strategic acquisitions: Affinity Biologicals (2018) for coagulation antibodies and ELISA kits, and George King Bio-Medical (2025) for specialty hemostasis products.

Differentiator

Problem solved

Functional benefit

Brands

• CRYO*check*: The company's line of frozen hemostasis diagnostic products including controls, calibrators, reagents, and diagnostic kits for coagulation testing.
• PBInsider
• Fritsma Factor

Quantifiable outcome

• Products stable for at least two years from date of manufacture, many for three years
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Ten partnerships are on record, tiered core.

• George King Bio-MedicalcoreStrategic or Co-development Partner · 16 October 2025Acquired George King Bio-Medical, Inc. on October 16, 2025. George King Bio-Medical is a provider of hemostasis diagnostic products with close ties to the bleeding disorders community. Founded in 1973 by George J. King, the company offers quality fresh frozen human plasmas for clinical laboratories.
• Affinity BiologicalscoreStrategic or Co-development Partner · 1 November 2018Acquired Affinity Biologicals in November 2018. Affinity Biologicals is a primary manufacturer of products used worldwide in thrombosis and hemostasis research and diagnostics, offering an extensive line of coagulation-related antibodies and other products and services.
• Alpha LaboratoriescoreChannel Partner/ Reseller/ DistributorUK distributor covering England, Scotland, and Wales. Located at 40 Parham Drive, Eastleigh, Hampshire SO50 4NU, United Kingdom.
• CoaChrom DiagnosticacoreChannel Partner/ Reseller/ DistributorEuropean distributor covering Austria, Denmark, Finland, Germany, Norway, and Sweden. Located at Hauptstraße 5, 2344 Maria Enzersdorf, Austria.
• CryopepcoreChannel Partner/ Reseller/ DistributorEuropean distributor covering Belgium, France, Luxembourg, Netherlands, and Spain. Located at 83 rue Yves Montand – Parc 2000, 34080 Montpellier, France.
• ELITech GroupcoreChannel Partner/ Reseller/ DistributorDistributor covering Australia and New Zealand. ELITech Australia at 65 Mills Road, Braeside, VIC, 3195, Australia.
• Tokyo Future Style, Inc.coreChannel Partner/ Reseller/ DistributorDistributor covering Japan and Taiwan. Japan office at TCI A-13, 1-6, Sengen 2-Chome, Tsukuba City, Ibaraki, Japan 305-0047.
• Endotell AGcoreChannel Partner/ Reseller/ DistributorSwiss distributor. Located at Gewerbestrasse 25, 4123 Allschwil, Switzerland.
• FannincoreChannel Partner/ Reseller/ DistributorIrish distributor covering Republic of Ireland and Northern Ireland. Located at Fannin House, South County Business Park, Leopardstown, Dublin 18.
• MoreBio Inc.coreChannel Partner/ Reseller/ DistributorKorean distributor. Located at #F810, Testa Tower, 25, Misagangbyeonseo-ro, Hanam-si, Gyeonggi-do, Republic of Korea, 12918.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Diagnostica Stago: French-headquartered global specialist in hemostasis and coagulation diagnostics, manufacturing analyzers and a broad portfolio of reagents, controls, and calibrators that directly overlap Precision BioLogic's CRYO*check* product lines across PT, APTT, factor assays, and lupus anticoagulant testing.
• Sysmex Corporation: Global leader in hematology and hemostasis diagnostics offering automated coagulation analyzers and reagent systems; competes directly with Precision BioLogic in factor assays, lupus anticoagulant testing, and routine coagulation controls.
• Werfen (Instrumentation Laboratory): Through its Instrumentation Laboratory business, Werfen offers ACL series hemostasis analyzers and a broad reagent menu in coagulation, factor deficiency testing, and lupus anticoagulant detection that directly competes with Precision BioLogic's specialty plasmas and factor deficient plasma reagents.
• Helena Laboratories: US-based specialty manufacturer of clinical electrophoresis, hemostasis, and coagulation products including factor deficient plasmas, lupus anticoagulant reagents, and quality controls — closely comparable to Precision BioLogic's reagent and specialty plasma portfolio.
• Bio/Data Corporation: Specialty manufacturer of platelet aggregation reagents, coagulation controls, and factor deficient plasmas used in hospital and reference coagulation laboratories — a smaller, comparable specialty IVD peer in the hemostasis reagent niche.
• Sekisui Diagnostics: Diagnostics manufacturer with coagulation and hemostasis reagent offerings, including specialty plasmas, calibrators, and controls used in clinical labs — competing in the same end-user workflow as Precision BioLogic's CRYO*check* reagents.

Broad incumbents

• Siemens Healthineers: Diversified IVD major offering hemostasis analyzers and reagents within its Atellica/BCA portfolio alongside broader chemistry, immunoassay, and hematology lines — a broader incumbent whose reagent menu overlaps with Precision BioLogic at hospital and reference-lab customers.
• Roche Diagnostics: Global IVD leader providing coagulation reagents on its cobas t series analyzers, with deep contracts at large hospital networks. While broader than Precision BioLogic, its coagulation offerings address the same clinical end users.
• Abbott: Diversified diagnostics and medical device company with hemostasis reagents on its Alinity ci-series analyzers, serving many of the same hospital and reference-lab customers as Precision BioLogic with a broader reagent and instrument portfolio.

Emerging players

• HemoSonics: Emerging specialized hemostasis diagnostics company focused on viscoelastic testing (Quantra system) for point-of-care and specialty lab use; an emerging player in hemostasis diagnostics adjacent to Precision BioLogic's specialty assay positioning.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInca.linkedin.com/company/precision-biologic

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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

M&A2 records

Investments

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

Frequently asked questions about Precision BioLogic