No river too wide.
Clinical & Translational Research
Taking an application from the research lab into the clinic isn’t easy; but at Quantigen, we love a challenge! Our scientists use a methodical, time-tested approach for identifying the best strategy to meet each client’s needs. Whether for biomarker discovery and validation, diagnostic protocol design-device development, or clinical trials support, we’re ready to help you build a bridge to better patient care.
Method Development:
Confirming the validity of a bench-top method, whether a pre-clinical study or patient diagnostic, is an essential step in ensuring the reliability of subsequent results. Following CLSI guidelines, Quantigen both optimizes and experimentally tests the performance specifications for laboratory workflows of all kinds, including rare genetic polymorphism-based tests, quantitative assays for infectious disease, and many more. Quantigen assesses and meticulously documents performance parameters (e.g., limits-of-detection, linear dynamic range, precision, accuracy, and matrix-specific effects) deemed critical to a particular test; we then make adjustments to the protocol in cases where performance isn’t up to snuff. In this way, Quantigen ensures that the data a method generates are consistently accurate.
Regulatory Compliance Expertise
Quantigen laboratories are licensed for clinical testing in all 50 US states, including New York, California, Pennsylvania and Maryland. We maintain CLIA certification, CAP accreditation, Good Clinical Practice (GCP) certification, and ISO15189 accreditation; ISO13485 accreditation is in process.
Quantigen scientists work to scrupulously meet all regulatory requirements related to the development and use of both IVD (in vitro diagnostic) assays and LDTs (lab-developed tests). Our clients recognize the importance of fulfilling accepted standards of reagent and assay performance metrics in designing assays for human diagnostic use. However, we always invite our customers to define their own needs for diagnostic-test development support, even when they exceed the mandates of federal oversight bodies.
Laboratory Support for Clinical Trials
From laboratory infrastructure, to quality systems, to experienced personnel, Quantigen Biosciences is equipped to provide lab support for clinical trials of all sizes, from just a handful of samples to hundreds or even thousands. In addition to the regulatory certifications listed above, Quantigen scientists and quality experts have the credentials and experience needed to analyze your most precious clinical samples, using a variety of laboratory techniques across multiple scientific disciplines. From the moment of sample receipt until final data are reported, our LIMS and associated sample-tracking systems help ensure strict chain of custody and maintenance of critical sample identifiers.
Recent Partnerships:
Bill & Melinda Gates Foundation: DeWorm3
Soil-transmitted helminths (STH) are parasitic worms associated with numerous health problems, including chronic malnutrition. The WHO estimates that one-quarter of the world’s population is currently infected.
DeWorm3 is a five-year surveillance study, examining the effectiveness of a mass-drug administration (MDA) protocol to interrupt STH transmission among affected populations in India, Benin, and Malawi.
Quantigen and its DeWorm3 collaborators have validated a DNA isolation procedure and a high-throughput, lyophilized, multiplex qPCR-based assay specific to four STH species. We have also created a comprehensive set of standard operating procedures and a rigorous proficiency testing program, which together are helping Quantigen to deploy our test into international partner laboratories.
Future plans at Quantigen: Over the study’s duration, our lab will test approximately 200,000 pre-and post-treatment stool samples for STH infection; in this way, study monitors can ensure that incidence levels following multiple rounds of MDA fall below the threshold (approx. 2%) at which future lateral transmission should be eliminated.
In addition, we will perform a clinical study to validate the STH test as a patient diagnostic – one with much higher sensitivity than the current, microscopy-based standard of care.
Key collaborators:
- Bill and Melinda Gates Foundation
(primary sponsor) - University of Washington
- PATH (Seattle, WA)
- Smith College
(Dr. Steve Williams’ Lab) - Thermo Fisher Scientific
- Argonaut Manufacturing Services
Tuberculosis Assay Development
Tuberculosis, the leading cause of infectious disease-related deaths worldwide, is thought to kill some 1.5 million people per year. While curable when accurately diagnosed and properly treated, cases of both multi-drug resistance (to first-line antibiotics) and extensive-drug resistance (to multiple antibiotic classes) are on the rise.
Having access to inexpensive, broadly available, and minimally invasive testing is critical to curing TB, particularly in low-income settings where TB is most prevalent.
Quantigen is developing and validating a TB infection and antibiotic resistance testing workflow that combines the following:
- A minimally invasive tongue collection (as opposed to sputum)
- An extraction-free lysis procedure
- A low-cost PCR-based solution with medium-throughput capabilities
By rapidly and inexpensively identifying patients with active TB, as well as those with specific antibiotic resistance patterns, Quantigen’s test will address the main needs of resource-constrained countries with high rates of TB infection.
Key collaborators:
- Bill and Melinda Gates Foundation(primary sponsor)
- PATH (Seattle, WA)
- Thermo Fisher Scientific
Diagnosing Bacterial Vaginosis: Results of 600-Patient Study
In 2018, Quantigen completed a multi-center study designed to develop a molecular-based diagnostic for bacterial vaginosis. With expert contributions from its various partners, including RDI (Van Nuys, CA) and Coriell Life Sciences (Philadelphia), Quantigen tested vaginal swab samples from 550 symptomatic and 50 asymptomatic patients using a panel of real-time PCR assays designed to both healthy lactobacilli and BV-associated microorganisms. The qPCR results for this microbial panel were compared to Nugent scoring for each patient, with supporting Amsel data serving to ascribe a diagnosis to Nugent "intermediates." The result was a molecular diagnostic for BV with high sensitivity and specificity (both > 90%) relative to Nugent -- one that also eliminates ambiguous intermediate calls.
Because Quantigen’s BV test uses the same vaginal swab required to test for other syndromic conditions (aerobic vaginitis, bacterial STIs, and candidiasis), physicians can choose to order a Comprehensive panel from a single specimen collection. In this way, they can receive a specific diagnosis for women with non-specific symptoms that do not clearly point to a definitive cause. Promptly initiating the most appropriate treatment is thereby possible within just a day or so of sample collection.
Quantigen’s recently-refined panel is manageably small, consisting of 6 pathogenic and two non-pathogenic (i.e., “healthy”) microbes: