What Embryotech Laboratories does

Embryotech Laboratories Inc is an ISO 17025-accredited, GLP-compliant contract research organization and biological products supplier focused on the assisted reproductive technologies (ART) industry. Founded in 1994 and headquartered in Haverhill, Massachusetts, the company provides toxicity and functionality testing services — including the Mouse Embryo Assay (MEA) at 1-cell, 2-cell, and IVF stages, Human Sperm Survival Assay (HSSA) with Computer Assisted Sperm Analysis (CASA), Limulus Amebocyte Lysate (LAL) endotoxin assays, and ANSI/AAMI/ISO 11737-1 bioburden testing for medical devices — that are accepted by FDA and other regulatory bodies via ANAB and ILAC-MRA recognition. Its primary customers are pharmaceutical and biotech firms, medical device manufacturers, fertility clinics and IVF laboratories, and academic research institutions; revenue is generated through per-test professional service fees, sale of cryopreserved and fresh mouse embryos and hamster ova, and branded EMBRYO LOVE / EMBRYO LOVE HTF culture media. Distribution is direct via phone, email, and website inquiry forms, with biological products shipped globally under dry liquid nitrogen vapor shippers; pricing is quote-based with 5–7 business day turnaround, and the company operates as a subsidiary of Hamilton Thorne Ltd.

Name

Embryotech Laboratories

Legal name

Embryotech Laboratories Inc

Website

https://embryotech.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Embryotech Laboratories is an ISO 17025-accredited contract research organization providing toxicity, endotoxin, bioburden, and sperm quality testing for the assisted reproductive technologies and medical device industries, supplying fertility clinics, pharma, and academic labs worldwide.

Ownership category

akta.pro rank

Headquarters

HQ city

Haverhill

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research and Testing Services: CRO services providing toxicity and functionality testing for the assisted reproductive technologies industry, including MEA, HSSA, LAL, and bioburden testing. Revenue generated through per-test fees with 5-7 business day turnaround.
2. Embryo and Ova Products: Sale of cryopreserved mouse embryos at various stages (1-cell through blastocyst) and hamster ova. Products sold with various embryo counts per straw (10, 20, or 30). Also offers fresh embryo products.
3. Mouse Embryo Culture Media: Sale of Embryo Love branded culture media products including KSOM-based medium and HTF medium for IVF applications. Available in 20ml and 50ml formats.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Embryotech Laboratories is an ISO-17025 accredited Contract Research Organization providing specialized laboratory testing services for the assisted reproductive technologies (ART) industry. The company performs toxicity and functionality testing including Mouse Embryo Assays (MEA), Human Sperm Survival Assays (HSSA) with Computer Assisted Sperm Analysis (CASA), bacterial endotoxin testing (LAL), and bioburden testing for medical devices. The company also sells biological specimens (cryopreserved and fresh mouse embryos, hamster ova) and Embryo Love branded culture media to research and clinical customers worldwide.

Product overview

Embryotech Laboratories is an ISO-17025 accredited test laboratory and Contract Research Organization (CRO) offering a comprehensive portfolio of biological products and laboratory testing services for the assisted reproductive technologies (ART) industry. The core offering consists of toxicity and functionality testing services including Mouse Embryo Assay (MEA) at various stages (1-cell, 2-cell, IVF), Human Sperm Survival Assay (HSSA), Computer Assisted Sperm Analysis (CASA), Limulus Amebocyte Lysate (LAL) assays (Gel-Clot and Kinetic Turbidimetric), and Bioburden Testing for medical devices. The company also provides biological products including cryopreserved mouse embryos (1-cell through blastocyst stages), hamster ova, and fresh embryo products, along with EMBRYO LOVE™ and EMBRYO LOVE HTF specialized culture media. Additionally, Embryotech offers contract research and consulting services for drug discovery, development, and non-clinical laboratory studies. All testing services operate under GLP guidelines and 21 CFR Part 58 accreditation.

Differentiator

Problem solved

Functional benefit

Brands

• EMBRYO LOVE: Ready to use bicarbonate-buffered, Single-step Medium for embryo harvest and culture preimplantation mouse embryos for up to 120 hours. Complete KSOM based Medium.

Products and services

• Mouse Embryo Assay (MEA) Toxicity and functionality testing of raw materials, complete culture media, supplements, and disposable items using freshly harvested 1-cell or 2-cell mouse embryos under strict GLP guidelines, used by pharma, biotech, medical device, and fertility clinic customers for regulatory submissions.
• Human Sperm Survival Assay (HSSA) and Related Sperm Assays Human sperm-based toxicity and functionality testing required by regulatory bodies for lot release or premarket submissions of ART-contact products, including HSSA, Sperm Penetration Assay (SPA), Sperm Motility Index Assay (SMI), Lubricant Barrier Assay (LBA), and Sperm Immobilization Assay (SIA), with Computer Assisted Sperm Analysis (CASA) providing motility parameters and DNA fragmentation analysis.
• Bacterial Endotoxin Testing (LAL) Detection of bacterial endotoxins using the Limulus Amebocyte Lysate (LAL) assay, available as a qualitative Gel-Clot method and a quantitative Kinetic Turbidimetric method with maximum sensitivity of 0.001 EU/mL, used by medical device manufacturers and IVF media producers for lot release and quality control.
• Bioburden Testing for Medical Devices Medical device bioburden testing measuring the number and type of microorganisms present on a sample per ANSI/AAMI/ISO 11737-1, with extraction solution vacuum filtration through a 0.45-micron filter membrane, parallel culturing for fungi and aerobic and anaerobic bacteria, Gram staining, colony analysis, and recovery efficiency assay validation for sterility assurance and quality control.
• Contract Research & Consulting Services (CRO) Consultative contract research services for pharmaceutical, biotech, and device sponsors spanning drug discovery and development through commercial device and drug efficacy studies, including toxicity testing, embryo development work, in vitro fertilization, embryo cryopreservation, and non-clinical laboratory studies under GLP.
• Customized Testing Solutions Customized testing services for frozen and fresh mouse and hamster embryos and ova with configurable assay parameters including mouse strain, embryo stage, micro-drop size, and extraction time, offered to sponsors with specific QC needs not met by standard MEA protocols.
• Cryopreserved Mouse Embryos Cryopreserved mouse embryos at developmental stages from 1-cell through blastocyst, available with 10, 20, or 30 embryos per straw using a simple one-step thawing process, shipped worldwide in dry liquid nitrogen vapor shippers with Thaw Alert temperature monitoring for research and quality control use.
• Hamster Ova Cryopreserved hamster ova for research applications, available with 10, 20, or 30 ova per straw, suitable for Sperm Penetration Assay work and broader reproductive biology research.
• Fresh Embryo Products Fresh rodent embryo products shipped in specialized temperature-controlled containers that keep the embryos cool rather than frozen for research studies that cannot use cryopreserved specimens.
• EMBRYO LOVE (Mouse Embryo Culture Medium) Ready-to-use bicarbonate-buffered, single-step KSOM-based medium for embryo harvest and culture of preimplantation mouse embryos for up to 120 hours, available in 20ml and 50ml formats.
• EMBRYO LOVE HTF (Human Tubal Fluid Medium) Human Tubal Fluid medium (1X, liquid) optimized and validated for mouse IVF applications, available in a 50ml format.

Quantifiable outcome

• 80% blastocyst development required for passing MEA tests
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Hamilton ThornecoreOthersEmbryotech Laboratories Inc. is a Hamilton Thorne Company. Hamilton Thorne is a parent company that owns Embryotech Laboratories. The company website copyright notice lists Embryotech as 'A Hamilton Thorne Company' indicating a corporate ownership relationship.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Emerging players

• Toxikon: Preclinical contract research lab specializing in toxicology, biocompatibility, and medical device testing. Overlaps with Embryotech's reproductive toxicology and QC testing scope.
• NAMSA: Medical device-focused testing and regulatory consulting CRO offering microbiology, biocompatibility, and sterility services. Comparable on device QC and regulatory submission support.

Direct peers

• AccuGen Labs: Independent endotoxin (LAL) and microbial testing provider serving pharma and medical device manufacturers. Closely comparable on endotoxin and bioburden testing services.
• Nelson Laboratories: Specialized microbiology and medical device testing lab offering bioburden, endotoxin (LAL), and package validation. Directly comparable on the medical-device QC testing stack Embryotech serves.
• Pacific Biolabs: Microbiology and analytical testing lab providing LAL endotoxin and bioburden testing for medical devices and pharmaceuticals. Overlaps directly with Embryotech's bioburden and LAL service lines.

Broad incumbents

• Eurofins Scientific: Global testing services platform offering pharmaceutical, medical device, and microbiological testing. A scaled generalist that could move down-market into Embryotech's ART testing niche.
• Inotiv: Preclinical CRO with reproductive and developmental toxicology capability. Competes with Embryotech's contract research arm for ART and reproductive toxicology studies.
• Charles River Laboratories: Global CRO offering reproductive toxicology, endotoxin, and bioburden testing. Embryotech competes at the niche ART end of Charles River's portfolio but on a much smaller scale.
• Cytovance Biologics: Biologic CDMO with bioassay and potency testing capability. Adjacent in cell-based bioassays relevant to Embryotech's MEA and HSSA offerings.

Others

• BioTechne: Life science tools provider including specialty culture media and reagents for reproductive and stem cell research. Comparable on the Embryo Love media product line and biological reagents.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/EmbryotechLabs
• Facebookfacebook.com/EmbryotechLaboratories
• LinkedInlinkedin.com/company/hamilton-thorne-inc.
• Instagraminstagram.com/stories/embryotechlabs

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

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 Embryotech Laboratories