Asuragen

What Asuragen does

Asuragen is a molecular diagnostics company founded in 2006 and headquartered in Austin, Texas, operating as a wholly-owned subsidiary of Bio-Techne Corporation (NASDAQ: TECH) within the Diagnostics & Genomics Segment. The company develops, manufactures, and commercializes kitted assays, reagents, and laboratory services for clinical genetics and precision oncology through three product franchises: AmplideX (PCR/CE-based assays for inherited disorders including Fragile X/SMA/CFTR/C9orf72/DMPK/HTT), QuantideX (qPCR assays for CML monitoring, ESR1 liquid biopsy, PML-RARA, and JAK2 testing), and Armored RNA/DNA molecular quality controls used by third-party IVD developers. Asuragen also operates a CAP-accredited, CLIA-certified clinical laboratory providing ultra-sensitive ESR1 liquid biopsy testing on a fee-for-service basis with 7-day turnaround, and offers custom cGMP-grade OEM reagent manufacturing for IVD partners.

Name

Asuragen

Legal name

Asuragen, Inc.

Website

http://www.asuragen.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

251–500 employees

Short description

Asuragen, a Bio-Techne subsidiary, develops and commercializes molecular diagnostic kits — AmplideX (inherited disorders), QuantideX (oncology), and Armored RNA/DNA controls — alongside CLIA lab services for clinical reference labs, oncology testing facilities, and IVD developers in the US and EMEA.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

akta.pro secondary industries

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC)

Keywords

• Molecular diagnostic kits
• Genetic testing reagents
• Clinical oncology assays
• Nucleic acid controls
• Carrier screening tests

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Kits and Reagents: Sale of AmplideX genetic testing kits (FMR1, SMN1/2, CFTR, C9orf72, DMPK, HTT) and QuantideX oncology testing kits (BCR-ABL, ESR1, PML-RARA, JAK2). Revenue from catalog products and custom configurations.
2. CLIA Laboratory Services: Fee-for-service testing through CAP-accredited, CLIA-certified clinical laboratory. Provides ultra-sensitive ESR1 mutation liquid biopsy testing with 7-day turnaround. Targets clinical decision-making and clinical trial support.
3. Molecular Quality Controls: Sale of Armored RNA Quant, Armored DNA Quant, and other molecular diagnostic control products. Includes catalog products and made-to-order custom controls for diagnostic assay development.
4. OEM and Custom Manufacturing Services: Custom reagent development and manufacturing services for IVD companies. Full product lifecycle support from assay development to commercialization. Includes cGMP-grade materials and regulatory compliance.
5. Molecular Assay Reagents: Sale of assay reagents including TSM III buffer solution, RNARetain sample collection devices, and access to FFPE tumor bank with over 100,000 clinical specimens.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

Asuragen develops, manufactures, and commercializes molecular diagnostic test kits and reagents under the AmplideX brand (genetic/inherited disorders), QuantideX brand (oncology monitoring and liquid biopsy), and Armored RNA/DNA (molecular quality controls). The company also operates a CAP-accredited, CLIA-certified clinical laboratory providing ESR1 mutation liquid biopsy testing services, and offers custom OEM manufacturing of nucleic acid controls for IVD developers worldwide.

Product overview

Asuragen, a Bio-Techne brand, provides a portfolio of molecular diagnostics products organized into three core segments: Genetics (AmplideX® brand), Oncology (QuantideX® brand), and Molecular Quality Controls (MolecularDx Controls/OEM). The AmplideX genetics portfolio includes kitted assays for inherited disorders — FMR1 (Fragile X Syndrome), SMN1/2 (Spinal Muscular Atrophy), CFTR (Cystic Fibrosis), C9orf72 (FTD/ALS), DMPK (Myotonic Dystrophy), HTT (Huntington's Disease) — available as standalone kits or unified via the AmplideX TRIO workflow, with the Nanopore Carrier Plus Kit extending to long-read sequencing via an Oxford Nanopore Technologies partnership. The QuantideX oncology portfolio covers BCR-ABL (CML monitoring with FDA clearance and IVDR Class C certification), BCR-ABL minor, ESR1 exoMutation (liquid biopsy), PML-RARA (APL), and JAK2 mutation testing. Molecular controls include Armored RNA Quant® and Armored DNA Quant™ products for SARS-CoV-2 and other infectious disease targets, plus custom OEM manufacturing. CLIA Lab Services offer ESR1 mutation testing. Reporter Software modules provide automated bioinformatics analysis across both portfolios. Xpansion Interpreter® provides AGG Interruption Testing Services.

Differentiator

Problem solved

Functional benefit

Brands

• AmplideX: Genetic testing assay kits for inherited disorders including fragile X syndrome (FMR1), spinal muscular atrophy (SMN1/2), cystic fibrosis (CFTR), and other trinucleotide repeat disorders.
• QuantideX
• Armored RNA

Products and services

• AmplideX PCR/CE FMR1 Kit PCR/CE-based assay kit for detection and sizing of CGG trinucleotide repeats in the FMR1 gene (Fragile X Syndrome). Uses Triplet Repeat Primed PCR (TP-PCR) to detect all alleles including full mutations; Class C IVDR certified in Europe. Used by clinical and research laboratories globally (over 200 installations).
• AmplideX mPCR FMR1 Kit PCR-only methylation assay kit for FMR1 gene analysis, eliminating the need for Southern blot analysis. Determines methylation status of each allele in male and female samples with a 10-hour turnaround (vs. 1 week for Southern blot). For clinical and reference laboratories performing Fragile X testing.
• AmplideX FMR1 Controls Proprietary mixtures of genomic DNA containing multiple FMR1 alleles (Normal, Premutation, Full Mutation) for use as process or batch controls. Cover multiple size ranges and different methylation states.
• AmplideX Nanopore Carrier Plus Kit Long-range PCR and long-read sequencing solution for carrier screening research, developed in partnership with Oxford Nanopore Technologies. Interrogates eleven genes contributing to high at-risk couple rates across four mixes with modularity. For genetic and reproductive health laboratories performing expanded carrier screening research.
• AmplideX PCR/CE SMN1/2 Plus Kit Comprehensive PCR/CE assay for SMN1 and SMN2 copy number quantification and variant detection (including SMN1 gene duplication and SMN2 disease modifier variants) from a single PCR reaction in less than four hours. For SMA carrier screening and diagnosis.
• AmplideX PCR/CE CFTR Kit Targeted PCR/CE CFTR variant panel providing equitable coverage across ethnically diverse populations for cystic fibrosis carrier screening. Based on recent large-scale population studies.
• AmplideX PCR/CE C9orf72 Kit Single-tube Repeat-Primed PCR assay for high-resolution genotyping of GGGGCC hexanucleotide repeat expansions in the C9orf72 gene. Associated with frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS).
• AmplideX PCR/CE DMPK Kit PCR assay for detection and sizing of CTG trinucleotide repeats in the DMPK gene associated with Myotonic Dystrophy Type 1.
• AmplideX PCR/CE HTT Kit PCR/CE assay for detection and sizing of CAG trinucleotide repeats in the HTT gene associated with Huntington's Disease, using two-primer anchor-primed PCR with capillary electrophoresis; delivers results from as little as 10ng gDNA.
• AmplideX TRIO Workflow Unified PCR workflow for analyzing FMR1, SMN1/2, and CFTR in one streamlined workflow, optimized for widely established laboratory equipment with automated analysis software. Delivers genetic results from DNA in under one day.
• QuantideX qPCR BCR-ABL IS Kit First FDA-cleared CML monitoring assay for BCR-ABL Major breakpoints (e13a2, e14a2) with direct reporting on the International Scale. Deep clinical sensitivity of 0.002% IS (MR4.7). Class C IVDR certified in Europe. For clinical laboratories performing chronic myeloid leukemia monitoring.
• QuantideX qPCR BCR-ABL minor Kit Ultra-sensitive qPCR detection of BCR-ABL1 minor fusion transcripts (e1a2) from whole blood specimens for rare leukemic variant monitoring, with LOD of 4.61 log reduction (0.0025% ratio).
• QuantideX qPCR ESR1 exoMutation Kit First multianalyte liquid biopsy assay tailored for detecting 11 of the most prevalent ESR1 mutations using both cell-free DNA (cfDNA) and exosomal RNA (exoRNA). Variant detection as low as 0.025% VAF. For oncology laboratories performing metastatic breast cancer monitoring.
• QuantideX qPCR PML-RARA Kit Highly sensitive and scalable multiplex RT-qPCR detection of three PML-RARA aberrant fusions (bcr1/bcr2/bcr3) for acute promyelocytic leukemia (APL) monitoring, with results in approximately four hours.
• QuantideX qPCR JAK2 Kit Quantitative PCR kit for JAK2 mutation detection used in myeloproliferative neoplasm diagnostics.
• Armored RNA Quant SARS-CoV-2 Controls In vitro transcribed RNA encapsulated in a protective protein coat creating virus-like particles resistant to nuclease degradation. Used as extraction/process quality controls or positive diagnostic reference controls for SARS-CoV-2 and variants (Alpha, Beta, Gamma, Delta, Omicron).
• Armored RNA/DNA Quant Catalog Controls Nucleic acid controls utilizing Armored Technology (protein coat protection) including Armored RNA Quant Respiratory Triplex Control (covering SARS-CoV-2, Influenza A/B, RSV), Armored RNA Quant Internal Process Control, and Armored RNA Quant EPA-1615 for environmental testing. NIST-traceable standardization.
• Custom Nucleic Acids / OEM Services Custom molecular control reagent manufacturing including custom plasmid DNA, in vitro transcribed RNA, and Armored RNA/DNA products with cGMP manufacturing capabilities. Full product lifecycle support from assay development to commercialization. For IVD developers and diagnostic companies.
• ESR1 Mutation CLIA Lab Testing Service Ultra-sensitive (<0.1% VAF) CLIA-certified liquid biopsy testing service covering 11 most prevalent ESR1 ligand-binding domain mutations, with results delivered within 7 business days of sample receipt. Performed in CAP-accredited, CLIA-certified laboratory. Targets clinical decision-making and clinical trial support.
• AmplideX / QuantideX Reporter Software Proprietary bioinformatics software modules providing automated peak calling, variant annotation, batch-level QC and run metrics, and LIMS-compatible result exports (CSV/Excel/PDF) for AmplideX and QuantideX assay data analysis. Includes machine-learning-based Sample-Aware capabilities for constant result quality monitoring.

Quantifiable outcome

• 875-fold improvement in sensitivity compared to Southern blot for FMR1 testing
• +4 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Oxford Nanopore TechnologiescoreTechnology or Integration · 1 January 2024Strategic partnership to develop and commercialize the AmplideX Nanopore Carrier Plus Kit for long-read sequencing-based carrier screening research. Combines Asuragen's gold-standard PCR technology with Oxford Nanopore's long-read DNA sequencing capabilities to create first sequencing system identifying challenging yet high prevalence carrier genes in a single unified workstream.
• Wave Life SciencesminorStrategic or Co-development Partner · 1 January 2024Partnership on Wave Life Sciences' PRISM RNA medicines platform. Asuragen contributes to RNA therapeutic development through this collaboration, which has been described as incrementally positive for Wave's investment narrative.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• QIAGEN: QIAGEN is a major molecular diagnostics and sample technologies company offering a broad portfolio of PCR-based assays, reagents, and bioinformatics — directly comparable to Asuragen's AmplideX and QuantideX kits as well as its OEM/custom manufacturing services, though at significantly larger scale.
• Roche Diagnostics: Roche Diagnostics is the global leader in molecular diagnostics with PCR-based cobas systems and a comprehensive oncology and genetic testing menu — represents the dominant competitive incumbent that Asuragen's differentiated niche assays must defend against in clinical lab accounts.
• Hologic: Hologic is a major molecular diagnostics player (Panther system, Aptima assays) serving clinical laboratories with high-throughput molecular testing — comparable to Asuragen's clinical lab channel strategy and IVD reagent business, though Hologic operates at substantially larger scale and menu breadth.
• Bio-Rad Laboratories: Bio-Rad is a leading life science and clinical diagnostics company with PCR/qPCR instrumentation, reagents, and digital PCR technology — overlapping with Asuragen's molecular diagnostics reagent business and quality controls portfolio, particularly in clinical and research laboratory channels.
• Abbott Molecular: Abbott Molecular offers the m2000 system and a broad menu of infectious disease and genetic testing assays — a key incumbent comparable to Asuragen's clinical lab serving model and IVD reagent business, with much greater global commercial reach.

Direct peers

• Natera: Natera is a genetic testing company specializing in reproductive health (carrier screening, NIPT) and oncology minimal residual disease — directly comparable to Asuragen's AmplideX carrier screening portfolio and oncology MRD monitoring products like QuantideX BCR-ABL.
• Exact Sciences: Exact Sciences is a molecular diagnostics leader (Cologuard, Oncotype DX) with strong oncology screening and monitoring products — comparable to Asuragen's QuantideX oncology monitoring strategy and CLIA lab services approach, though Exact Sciences is far larger and focused on high-volume indications.
• Guardant Health: Guardant Health is a liquid biopsy leader in oncology with cfDNA-based tests (Guardant360, Guardant Reveal) — directly comparable to Asuragen's QuantideX ESR1 exoMutation Kit and broader strategy of applying liquid biopsy to oncology monitoring, though Guardant operates at much larger scale.
• Myriad Genetics: Myriad Genetics specializes in genetic testing for inherited disorders and oncology (BRACAnalysis, Foresight carrier screen) — directly comparable to Asuragen's AmplideX genetic testing portfolio and oncology testing strategy, though focused more on LDT services than kitted reagents.
• Oxford Nanopore Technologies: Oxford Nanopore is both a partner (AmplideX Nanopore Carrier Plus Kit) and a long-read sequencing technology leader with growing clinical applications — comparable as both an ecosystem participant and a potential competing diagnostic assay developer in carrier screening and genetic disease research.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/Asuragen
• LinkedInlinkedin.com/company/asuragen

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds5 records

Investors4 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 Asuragen