Background

--KamTek is equipped with state-of-the-art laboratory and biorepository FACILITIES...

 

--Our operations are guided by a thorough and vetted TOTAL QUALITY MANAGEMENT SYSTEM...

 

BACKGROUND ON HISTORICAL OPERATIONS
  • Established in 1992, KTI was awarded Phase I and II SBIR grants (1995 and 1999) to develop DNA probes and a PCR-based diagnostic test for the detection of Leishmania. This experience led KTI to migrate such DNA diagnostic system from multi-well plates to the preparation of custom microarrays on glass slides, using not only for attached DNA probes but also linked protein and glycan probes as well. Over the years, these diagnostic test services have been performed for federal agencies (e.g., NCI, WRAIR and the U.S. Navy) and private industry, resulting in many high-quality publications.
  • KTI’s EBV (Epstein-Barr Virus) transformation service is an offshoot of a 1983 SBIR Phase I grant awarded to Braton Biotech. Dr. Sharan VedBrat was instrumental in preparing that grant proposal and took over the project when the original PI left the company. The technology is again offered as EBV transformation services to interested clients. Relatively recent example is an FDA contract awarded to KTI to develop cell lines using EBV transformation of B-cells of whole blood from individuals with specific HLA typing DNA sequences. These cell lines became a continuous source of supply of DNA specific genotype to develop reference panels of HLA DNA typing analyses for FDA.
  • KTI worked with Ariosa Diagnostics to EBV-transform B-cells from small quantities of cord blood from early stage pregnancy to establish cell lines for specific chromosomal abnormalities. First such successfully established cell line is Trisomy 18 from cord blood along with normal cell line from the mother blood to yield large quantities of DNA of each type. This service provided to Ariosa Daignostics has become the basis of a variety of prenatal “Harmony test kits” developed in alliance with Roche sequencing Inc. The Harmony Prenatal Test is a blood screening test for pregnant women that can be used as early as 10 weeks of pregnancy to evaluate cell-free fetal DNA circulating in maternal blood and diagnose the presence of this T18 trisomy (down syndrome) by NextGen Sequencing analyses. Roche Sequencing Solutions Inc. has expanded such blood test to diagnose a variety of other chromosomal abnormalities from circulating fetal DNA in mother’s blood. KamTek continues to assist Roche sequencing Inc. for development of additional cell lines via EBV transformation for these abnormalities and continue to provide sufficient cellular resource for control DNAs required for such tests. Roche is expanding the use of this prenatal test for global diagnostic market.
  • With funds from Elona Pharmaceuticals LLC, KTI established laboratories of Microbiology to evaluate the suitability of existing antimicrobials against different bacterial flora. That project resulted in the discovery of narrow spectrum but potent in vitro activity of Clofazimine (CFM) against Clostridium difficile (CD), at concentrations where rest of the gut microbiota is not affected. The data demonstrated greater efficacy of CFM as compared to current drugs being used to treat C. difficile infection (CDI) [e.g., metronidazole (MET) and vancomycin (VAN)]; these findings resulted in a U.S. patent application submitted by KTI. The data also became the basis of SBIR Phase-I funding used towards the investigation of the in vivo efficacy of CFM formulations (EK101) to treat the C. difficile-associated disease (CDAD) in an animal model and helped to propel the project forward.
  • NextGen Sequencing (NGS) laboratory at KTI is geared to provide microbial and human NGS sequencing services i.e. Whole Genome DNA and RNA sequencing, target sequencing and microbiome analysis using metagenomics, 16S rRNA, and 16S rRNA-ITS-23S rRNA.
  • Currently KTI is working on a project to establish a “Sound Gut Microbiome Monitoring System” for Evaluating Personal Health and Wellbeing is a prerequisite to this objective of studying microbiome during Clostridium difficile associated disease (CDAD) treatment. This is a collaborative project with Dr. Raja Mazumder’s laboratory at George Washington Hospital. For this project we have studied 160 fecal samples of healthy individuals of two groups, those using artificial sweeteners and a control group not using any sweeteners. For this cohort, we are using metagenomics analysis approach on NGS analysis. In addition, we have initiated a project on providing a handle on genetic diversity of chronically infected HCV patients and to determine its relevance to efficacy of treatment.
  • Currently, KTI holds a provisional patent for repurposing the antibiotic clofazimine for treatment against Clostridium difficile. The final patent on “Synergistic effect of Clofazimine and metronidazole” was recently received on Dec 26, 2017. This project has raised a need to establish the microbiome analysis as a tool to evaluate the efficacy of antibiotic treatment in animal model systems as well as in humans. KTI is offering this as pre-clinical service not only for antibiotics but also for any other drugs, especially oral drugs.
  • As a recipient of recent SBIR Phase I award, KTI also won I-Corps training program award from NIAID (NIH) to provide insight in to commercialization process for therapeutic products. The program has opened up unfathomable resources and concepts to facilitate early stages of development of EK101 and other associated drug products has provided to a very small business like KTI clear understanding of issues and requirements of later stages of this long term and very expensive (upwards of $100 million or more) endeavor. Through this training, KTI I-Corps team grew tremendously in understanding of the whole ecosystem of drug development process and various strategic players involved.