Ansh Labs is an ISO 13485:2016 certified manufacturer of quality immunoassays for the measurement of biomarkers in blood and blood-derived specimens. Ansh offers an extensive catalog of immunoassays that are distributed worldwide for research use only (RUO), CE-marked, and/or FDA-cleared for research and clinical diagnostic applications.
Ansh Labs (previously Diagnostic Systems Laboratories) has a 25+ year history of collaborating with research leaders to discover new biomarkers and translate discoveries into assays of preclinical and clinical value. Ansh Labs has now expanded supportive services by offering in-house testing to basic and translational clinical investigators as well as to clinical laboratories providing patient care testing. These fee-for-services include Ansh FDA-cleared, CE marked and/or RUO products as well as single and multiplex immunoassay testing using commercially available materials. Ansh Esoteric laboratories provides one-stop specimen handling by outsourcing specialty testing, for example LC/MS-MS testing for steroid hormones. When outsourcing Ansh Esoteric Laboratory provides specimen aliquoting, chain of custody, and quality control for specimens to be tested externally as well as internally.
The Ansh Esoteric Laboratory is CLIA-certified (45D2081313). The laboratory is directed by John Petersen PhD (Medical Director) and Patrick M Sluss, PhD (Scientific Director). Both Directors have over 25 years of experience directing high complexity, clinical laboratories in major academic hospitals (University of Texas Medical Branch and Massachusetts General Hospital/Harvard Medical School, respectively) as well as extensive research experience in biomarker discovery, development and validation. The laboratory conforms to Good Laboratory Practices and can provide testing services for regulated re-clinical and clinal trials.
Internal immunoassay of human and animal blood and blood derived biospecimens, focused on:
- Ansh assays for biomarkers in Women’s Health: Fertility, Oncofertility, Menopause and Gonadotoxicity, PCOS, Endometriosis, etc.
- Ansh biomarkers in Pregnancy: pre-eclampsia, gestational diabetes.
- Ansh IGF family and related Biomarkers: metabolic diseases
- Ansh TGF-β superfamily biomarkers: in vitro fertilization/embryo development, folliculogenesis, oncology
- CLIA-certified, SOP-guided testing of client specimens
- Customized testing quality control and quality assurance
- Customized validation, as needed, for biobanked specimens
- Specimen volume-sparing protocols
- Interpretive support
- Specimen design and collection support, including blood spot testing
- Specimen aliquoting and/or distribution services
- Biobanking services
- Option for return of residual specimen
- Chain of custody documentation
Immunoassay and Dx Device Development
- Custom configuration and assay development
- Validate assays for specific diagnostic purpose(s)
- Validation of assays in preclinical research animal models
- Testing to support regulatory submissions: pre-clinical and/or clinical
- Building relationships with customers and key opinion leaders to discover, develop and validate new assays
- Developing intellectual property
- Training in biomarker immunoassay and laboratory procedures
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