Impact Genetics

What Impact Genetics does

Impact Genetics is a CAP/CLIA-certified clinical genetic testing laboratory headquartered in Bowmanville, Ontario, with operational and shipping facilities in Brampton. The company provides diagnostic testing for five select hereditary conditions: retinoblastoma (RB), hereditary hemorrhagic telangiectasia (HHT), uveal melanoma (UM), tumor mismatch repair (MMR) sequencing for Lynch-like syndrome, and BAP1 tumor predisposition syndrome. Testing is conducted in a single Ontario laboratory using Next Generation Sequencing (NGS), Multiplex Ligation-dependent Probe Amplification (MLPA), microsatellite analysis, and allele-specific PCR, with proprietary methods including MYCN copy-number testing, RB1 promoter methylation detection, and mosaic mutation detection down to 1% allele frequency for eleven recurrent RB1 mutations.

The company's go-to-market is sales-led and clinical-specialist-driven: healthcare providers — geneticists, oncologists, and ophthalmologists — order tests through the company website; samples are shipped in from approximately 25 countries using the company's logistics infrastructure and courier partnerships. Revenue is generated on a fee-for-service, pay-as-you-go basis, with US billing and genetic counseling routed through LabCorp Integrated Genetics. Impact also retains remaining DNA for future re-testing at no added charge and offers genetic counseling coordination for HHT and BAP1-TPDS patients. The lab is fully accredited by CAP, registered under CLIA-88, compliant with ISO 15189:2012, accredited by the Ontario Lab Accreditation program, and a member of the European Molecular Quality Network.

Impact Genetics operates as a privately held subsidiary of Dynacare, a Canadian diagnostic services company, with no external venture or private equity funding disclosed. The company has tested more than 2,057 retinoblastoma families (2,141 including clinical families as of January 2015), building a variant interpretation knowledge base that supports diagnostic sensitivity across its rare-disease menu. Revenue is not publicly disclosed, and the company is positioned as a niche, disease-specialized laboratory serving a long tail of rare-disease referrals across North America and international markets.

Name

Impact Genetics

Legal name

Impact Genetics Inc.

Website

https://impactgenetics.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Impact Genetics is a CAP/CLIA-certified Canadian clinical genetic testing laboratory that runs NGS, MLPA, and PCR-based assays for rare hereditary diseases including retinoblastoma, HHT, uveal melanoma, tumor MMR, and BAP1-TPDS, serving healthcare providers across approximately 25 countries as a Dynacare subsidiary.

Ownership category

akta.pro rank

Product category

Clinical Genetic Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151), Testing Laboratories and Services (54138)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Genetic & Prenatal Testing Laboratories (HLAFAMAH)

akta.pro secondary industries

Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

Keywords

• Clinical genetic testing
• Hereditary cancer diagnostics
• Retinoblastoma testing
• Uveal melanoma prognosis
• Molecular diagnostics

Headquarters

HQ city

Brampton

HQ country

Canada

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, Supply Chain

Revenue model

1. Clinical Genetic Testing Services: Fee-for-service genetic testing for select diseases including Retinoblastoma, Hereditary Hemorrhagic Telangiectasia, Uveal Melanoma, BAP1 Tumor Predisposition Syndrome, and Tumor MMR Sequencing. Tests are ordered by healthcare providers and shipped to the CAP/CLIA certified laboratory for analysis.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Impact Genetics is a CAP/CLIA-certified clinical laboratory that performs fee-for-service genetic testing for a focused set of hereditary diseases, including Retinoblastoma, Hereditary Hemorrhagic Telangiectasia, Uveal Melanoma, BAP1 Tumor Predisposition Syndrome, and Tumor MMR Sequencing. Healthcare providers submit patient samples to the Ontario lab, where multi-method molecular analysis (NGS, MLPA, MSA, AS-PCR) is performed to deliver diagnostic and prognostic reports. The company also coordinates genetic counseling through partner LabCorp Integrated Genetics for US patients.

Product overview

Impact Genetics is a CAP/CLIA-certified clinical genetic testing laboratory providing diagnostic services for select hereditary cancers and genetic disorders. The company's portfolio consists of four main genetic testing services: Retinoblastoma (RB) testing, Hereditary Hemorrhagic Telangiectasia (HHT) testing, Uveal Melanoma (UM) prognostic testing, and Tumor MMR Sequencing Test. Additionally, BAP1 Tumor Predisposition Syndrome testing is offered. These tests are conducted in their CAP/CLIA certified laboratory and include comprehensive analysis methods such as Next Generation Sequencing (NGS), Multiplex Ligation-dependent Probe Amplification (MLPA), microsatellite analysis, and various PCR-based methods. The company also provides genetic counseling services, particularly for HHT and UM testing.

Differentiator

Problem solved

Functional benefit

Products and services

• Retinoblastoma (RB) Genetic Testing Clinical genetic testing for retinoblastoma including RB1 gene core promoter and exons 1-25 sequencing, MLPA copy-number analysis, MYCN copy-number testing, RB1 promoter methylation analysis, and allele-specific PCR for eleven recurrent RB1 mutations; offered to healthcare providers managing affected children and at-risk family members for diagnosis, carrier identification, prenatal testing, and surveillance planning.
• Hereditary Hemorrhagic Telangiectasia (HHT) Genetic Testing Clinical genetic testing for HHT using sequencing and MLPA deletion/duplication analysis of the ENG, ACVRL1, and SMAD4 genes with splice-site analysis and mosaic mutation detection; offered to clinicians and patients for molecular diagnosis, family-specific mutation identification, and reduction of costly clinical screening (MRI, CT) for non-carriers.
• Uveal Melanoma (UM) Genetic Prognostic Testing Prognostic genetic testing for uveal melanoma combining MLPA copy-number analysis on chromosomes 1, 3, 6, and 8, microsatellite analysis for chromosome 3 loss, and sequencing of GNAQ, GNA11, SF3B1, and EIF1AX; offered to ophthalmologists and oncologists to estimate metastatic risk, tailor surveillance, and stratify patients for treatment.
• Tumor MMR Sequencing Test (MLH1/MSH2/MSH6/PMS2/EPCAM) Somatic tumor MMR sequencing and MLPA deletion/duplication analysis of MLH1, MSH2, MSH6, PMS2, and EPCAM in tumor cells using NGS and MLPA; offered to oncologists and genetics providers for patients with abnormal IHC or MSI results but normal germline Lynch testing, to distinguish somatic MMR mutations from hereditary Lynch syndrome.
• BAP1 Tumor Predisposition Syndrome (BAP1-TPDS) Genetic Testing Genetic testing and counseling for BAP1 tumor predisposition syndrome, identifying germline BAP1 mutations associated with increased risk of uveal melanoma, lung adenocarcinoma, meningioma, and other malignancies; offered to clinicians and families with suspected hereditary cancer predisposition.

Quantifiable outcome

• Splice site analysis with minimum 25 nucleotides flanking each exon
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

One partnership is on record.

• LabCorp Integrated GeneticscoreStrategic or Co-development PartnerLabCorp Integrated Genetics provides comprehensive pre-test and post-test genetic counseling for HHT patients using telegenetics. Impact Genetics refers patients to LabCorp Integrated Genetics for genetic counseling services. Impact also processes US client billing through LabCorp for certain tests.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• GeneDx: Specialized clinical genetic testing lab (now part of Sema4) focusing on hereditary disorders including rare pediatric conditions and cancer predisposition; most directly comparable peer given overlap on specialized hereditary disease testing for clinicians.
• Centogene: Genetic diagnostics company focused on rare hereditary diseases with global sample logistics across multiple countries; most directly comparable peer to Impact on rare-disease specialization and international shipping model.
• Blueprint Genetics: Specialized clinical genetic testing lab offering hereditary disease panels and rare disease testing; overlapping capability set with Impact particularly in hereditary cancer syndromes and tumor testing.
• Ambry Genetics: Clinical genetic testing laboratory specializing in hereditary cancer and rare disease diagnostics; comparable on hereditary cancer testing depth and on offering comprehensive reports with variant interpretation support.
• Myriad Genetics: Established hereditary cancer testing laboratory with strong oncology and women's health franchises; overlaps with Impact on BAP1-TPDS and Lynch/HNPCC-related tumor testing pathways.
• PreventionGenetics: Clinical DNA testing laboratory (part of Exact Sciences) focused on inherited disease testing including rare hereditary conditions; comparable niche-specialist positioning similar to Impact's disease-focused model.
• Invitae: Clinical genetic testing laboratory offering hereditary cancer panels and rare disease testing; competes directly with Impact in germline cancer predisposition testing, though Impact retains depth advantage on specific niche indications like retinoblastoma.

Broad incumbents

• Labcorp Genetics (Labcorp): Major commercial clinical laboratory with extensive genetic testing menu including hereditary cancer and oncology; broader portfolio than Impact but directly relevant as Impact's US billing/counseling partner and a potential competitive incumbent.
• Quest Diagnostics: Large diversified clinical laboratory with genetic and molecular diagnostics capabilities including hereditary cancer testing; broad incumbent with overlapping capabilities though typically less specialized in ultra-rare conditions like retinoblastoma.

Emerging players

• Foundation Medicine: Molecular diagnostics company (now part of Roche) specializing in comprehensive tumor genomic profiling; overlaps with Impact on somatic tumor testing (Lynch/MMR and uveal melanoma segments) but operates at a much larger scale and broader indication set.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/impactgenetics
• Facebookfacebook.com/ImpactGeneticsInc
• LinkedInlinkedin.com/company/impact-genetics-inc

Compliance5 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 Impact Genetics