Partnered R&D

Asuragen’s R&D team and our CAP-accredited CLIA laboratory are both used to support our internal and partnered product development. Our wide menu of capabilities coupled with our flexible partnering approach means you can utilize us as a single provider to partner across your research, development and diagnostic needs.

Our wide menu of offerings range from RNA-Seq to targeted, high homology sequencing. This broad technology reach ensures we can tailor our test offering to best match your project and clinical needs across Genetics, Oncology and the broader Custom & Companion Diagnostic space.

Routine Applications

Custom & Companion Diagnostics

We leverage our R&D team, established CAP-accredited CLIA laboratory capabilities and extensive experience with molecular technologies to support your biomarker discovery and detection needs. Our bioinformatics-driven approach coupled with our significant experience with complex, hard-to-amplify targets and samples, enables us to rapidly confirm and validate clinically-relevant mutations and accelerate your research and development cycles.

Asuragen offers a broad range of technologies with high sensitivity and accuracy supported by an advanced bioinformatics capability, including:

Genetics

Leveraging proprietary enabling technologies, we have built a menu of tests to interrogate clinically-relevant GC-rich and high homology sequences.

In order to improve the understanding of genetic disorders, we have developed a range of tests for fragile X syndrome and Amyotrophic Lateral Sclerosis (ALS).

Fragile X:
FMR1 Analyses

  • PCR/CE FMR1 for detection of CGG repeats
  • mPCR to examine methylation status
  • Xpansion Interpreter® for interrogation of AGG interruptions

Learn more about Xpansion Interpreter

ALS:
PCR/CE C9orf72

Oncology

Leveraging our broad molecular biology and oncology capabilities, we have developed a menu of clinically-relevant tests to support needs ranging from development to diagnostics.

qPCR BCR-ABL
Detection of extremely low levels of the t(9:22) Philadelphia chromosome and reporting directly onto the International Scale (IS)

NGS Pan Cancer
Accurate detection of somatic mutations across many clinically relevant oncogenes from difficult to use FFPE tissues with limiting DNA quantities

NGS ERBB2
Investigate the impact gene mutations and amplifications have on efficacy of targeted therapies directed at the HER family of receptors

NGS TP53
Determination of the effect of activating or inactivating somatic or germline mutations on cell cycle, apoptosis, or therapeutic efficacy

CAP-Accredited CLIA Lab

Asuragen’s laboratory is licensed/certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and the requirements of the state of Texas licensure program. The Asuragen laboratory is accredited by the College of American Pathologists (CAP).

CTA Testing Site

Assays are analytically validated in Asuragen’s CAP-accredited CLIA lab with quality assurance oversight compliant with 42CFR493 regulations and the guidelines established by the 2009 AMP Clinical Practice Committee as well as the 2012 CAP molecular checklist.

Partnered R&D

Asuragen’s R&D team and our CAP-accredited CLIA laboratory are both used to support our internal and partnered product development. Our wide menu of capabilities coupled with our flexible partnering approach means you can utilize us as a single provider to partner across your research, development and diagnostic needs.

Our wide menu of offerings range from RNA-Seq to targeted, high homology sequencing. This broad technology reach ensures we can tailor our test offering to best match your project and clinical needs across Genetics, Oncology and the broader Custom & Companion Diagnostic space.

Routine Applications

Custom & Companion Diagnostics

We leverage our R&D team, established CAP-accredited CLIA laboratory capabilities and extensive experience with molecular technologies to support your biomarker discovery and detection needs. Our bioinformatics-driven approach coupled with our significant experience with complex, hard-to-amplify targets and samples, enables us to rapidly confirm and validate clinically-relevant mutations and accelerate your research and development cycles.

Asuragen offers a broad range of technologies with high sensitivity and accuracy supported by an advanced bioinformatics capability, including:

partnerRD

 

Genetics

Leveraging proprietary enabling technologies, we have built a menu of tests to interrogate clinically-relevant GC-rich and high homology sequences.

In order to improve the understanding of genetic disorders, we have developed a range of tests for fragile X syndrome and Amyotrophic Lateral Sclerosis (ALS).

Fragile X:
FMR1 Analyses

  • PCR/CE FMR1 for detection of CGG repeats
  • mPCR to examine methylation status
  • Xpansion Interpreter® for interrogation of AGG interruptions

Learn more about Xpansion Interpreter

ALS:
PCR/CE C9orf72

Oncology

Leveraging our broad molecular biology and oncology capabilities, we have developed a menu of clinically-relevant tests to support needs ranging from development to diagnostics.

qPCR BCR-ABL
Detection of extremely low levels of the t(9:22) Philadelphia chromosome and reporting directly onto the International Scale (IS)

NGS Pan Cancer
Accurate detection of somatic mutations across many clinically relevant oncogenes from difficult to use FFPE tissues with limiting DNA quantities

NGS ERBB2
Investigate the impact gene mutations and amplifications have on efficacy of targeted therapies directed at the HER family of receptors

NGS TP53
Determination of the effect of activating or inactivating somatic or germline mutations on cell cycle, apoptosis, or therapeutic efficacy

CAP-Accredited CLIA Lab

Asuragen’s laboratory is licensed/certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and the requirements of the state of Texas licensure program. The Asuragen laboratory is accredited by the College of American Pathologists (CAP).

CTA Testing Site

Assays are analytically validated in Asuragen’s CAP-Accredited CLIA lab with quality assurance oversight compliant with 42CFR493 regulations and the guidelines established by the 2009 AMP Clinical Practice Committee as well as the 2012 CAP molecular checklist.

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