HiTech Analytical and Diagnostic Solutions


Laboratory services company offering contract bioanalytical assay development, validation, and testing for biologics, vaccines, diagnostics and consumer samples. Services include multiplex real-time PCR method development, ELISA assays, microbiome analysis (direct-to-consumer stool testing offered as a non-CLIA nutrigenomic assay), carbohydrate/glycosylation analysis, stability testing, and food authenticity testing. Operates GLP/CLIA-capable facilities with standard analytical instrumentation and provides regulatory and clinical development support.

Industries

biopharma
biotechnology
health-diagnostics
medical

Nr. of Employees

small (1-50)

HiTech Analytical and Diagnostic Solutions

17b Firstfield Road, Suite #207, Gaithersburg, Maryland 20878, United States


Products

Contract assay development and qualification

Custom development and qualification of molecular and immunoassays (multiplex PCR, ELISA) and bioanalytical methods for research, clinical trials and product development.

Bioanalytical testing for biologics

Analytical services for biologics including aggregate and purity testing, variant analysis, peptide mapping, glycosylation profiling and impurity testing.

Food and beverage authenticity testing

Analytical assays for detection of adulteration and verification of authenticity in fruit juice and related products, including multiple chemical profiling methods.


Services

Non‑CLIA stool microbiome testing offered as a nutrigenomic assay; includes kit shipping and result reporting.

Expertise Areas

  • Bioanalytical assay development
  • Multiplex PCR method development
  • ELISA and immunoassays
  • Microbiome analysis and nutrigenomics
  • Show More (7)

Key Technologies

  • Real-time PCR (multiplex)
  • ELISA
  • High-performance liquid chromatography (HPLC)
  • Liquid chromatography–mass spectrometry (LC-MS)
  • Show More (6)

News & Updates

Reference link to CDC blog on advancing microbiome science for infection prevention, clinical care and public health.

Site references several published studies on gut microbiome associations with obesity, diabetes and colorectal cancer (World Journal of Gastroenterology 2021; BMC Endocrine Disorders 2023; Nature and institutional reports cited on site).


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