Agena Bioscience


Developer and supplier of mass-spectrometry-based genetic analysis systems, consumables, and assay services for targeted genotyping, mutation profiling, pharmacogenetics, and liquid biopsy research. Offers targeted panel design, custom assay development, laboratory automation modules, and data-analysis software. Demonstrates experience with high-throughput laboratory deployment, regional commercial partnerships, and regulatory submissions for in vitro diagnostic products in selected markets.

Industries

Biotechnology
Health Care
Health Diagnostics
Medical Device
Productivity Tools
Biotechnology Research

Nr. of Employees

medium (51-250)

Agena Bioscience


Patents

Products and processes for multiplex nucleic acid identification

US-12630865-B2

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Methods and compositions for the quantitation of mitochondrial nucleic acid

US-12492428-B2

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Multiplexed method for the identification and quantitation of minor alleles and polymorphisms

US-12454722-B2

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Products and processes for nucleic acid detection and quantification

US-12188083-B2

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Compositions and processes for improved mass spectrometry analysis

US-12077819-B2

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Multiplexed method for the identification and quantitation of minor alleles and polymorphisms

US-11680289-B2

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Products

MALDI-TOF genotyping instrument platform and consumables

Array-based MALDI-TOF instrument platform and consumables for high-throughput multiplexed genotyping and targeted mutation profiling across multiple plate formats.

Automated modules for post-amplification sample preparation

Automated chip preparation and sample-dispensing modules for desalting, sample transfer, and array loading to reduce hands-on time and variability.

CE-marked targeted oncology diagnostic panels (Europe)

CE‑IVD marked targeted diagnostic panels for oncology applications (examples include lung and colon cancer panels) sold in European markets.

FDA 510(k)-cleared genotyping test and combined diagnostic system

Genotyping assay and associated combined-function diagnostic system cleared by the U.S. Food and Drug Administration for designated genetic tests and clinical laboratory use.

MassARRAY System

A flexible, cost-effective mass spectrometry genetic analyzer and system enabling laboratories to efficiently analyze known variants associated with hereditary genetic conditions.

MassARRAY System with CPM 384

An open targeted molecular analysis system combining mass spectrometry with end-point PCR, utilizing MALDI-TOF technology for precise genetic variant detection.

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Services

Design and development of predesigned and custom multiplexed genetic panels across pharmacogenetics, oncology, hereditary genetics, methylation, and sample-integrity applications.

Laboratory services for sample testing, validation, and regional service through certified third-party providers and distribution partners.

Expertise Areas

  • Targeted molecular genotyping and mutation profiling
  • Pharmacogenetics panel development and deployment
  • Liquid biopsy and low-allele-frequency variant detection
  • Targeted oncology panels including fusion/translocation detection
  • Show More (5)

Key Technologies

  • MALDI-TOF mass spectrometry
  • Multiplex PCR
  • Single-base extension (primer-extension) genotyping
  • Ultrasensitive targeted chemistries for low variant allele frequency
  • Show More (5)

News & Updates

Presence at major genomics and molecular diagnostics conferences (PGRN, APHL Newborn Screening Symposium, ASHG, AMP, PAG) with exhibition or participation planned.

Article describing MALDI-TOF workflows, sample preparation, and applications for genotyping, mutation profiling, CNV analysis, and biomarker detection in research.

Overview of distinct targeted chemistries and workflows for genotyping, high-sensitivity variant detection, liquid biopsy assays, and sample-integrity panels.

Article on the role of pharmacogenetics in drug metabolism research and incorporation of PGx into molecular studies.

Multiple company press releases covering transcriptome fusion panels, CE‑IVD oncology panels in Europe, partnerships for regional commercialization, expanded distributor network, and laboratory partnerships for high-volume clinical testing.

Regulatory clearance obtained from the U.S. Food and Drug Administration for a genotyping test and combined diagnostic system intended for clinical laboratory use.

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