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Clinical Diagnostics

Bringing streamlined genetic testing into everyday care

 
 

Clinically actionable patient testing for infectious disease and antibiotic sensitivity, and precision medicine for high-quality medication management.

 

Infectious Disease

Women’s Health and STI Testing
  • The Quantigen® Women’s Health Portfolio utilizes the most advanced PCR technology. We provide accurate and clinically actionable information for the most common infections of the genital tract, and in less time than culture-based tests. The Comprehensive Panel includes 23 assays for bacterial, fungal, protozoan, mycoplasmal, and viral pathogens. A single vaginal swab can be tested using one or all assay panels, except HSV testing, which requires a separate swab from the base of an active lesion. Collection Kits include clear instructions, sample collection materials, and secure, convenient transport containers.
Urinary Tract Infection Testing

The Quantigen® Urinary Tract Infection (UTI) test utilizes the most advanced qPCR technology to quantify infectious agents from patient urine. Intermediate and high positives are then tested for antibiotic sensitivity to help identify the most effective treatment. Our UTI Panel includes individual tests for 16 bacterial and one fungal target, all known to cause UTI. Follow-up antibiotic sensitivity testing phenotypically screens for susceptibility to a large array of common antibiotics used for both Gram-positive and Gram-negative bacteria. Clinicians can now prescribe the most appropriate antimicrobial treatment with no guesswork—and be alerted to possible antibiotic-resistance patterns in their geographic area. Test requires a single urine collection. Collection Kits include clear instructions, sample collection materials, and secure, convenient transport containers.

SARS-CoV-2 Patient Testing and Variant Surveillance

In spring, 2020, Quantigen began patient testing for the novel coronavirus (SARS-CoV-2) in samples from state-sponsored collection sites located throughout Indiana. This endeavor was undertaken through a collaboration with both Eli Lilly and the Indiana State Department of Health (ISDH), with the latter providing testing instrumentation and reagents in support of Quantigen’s rapid mobilization. As of March of 2021, Quantigen had tested in excess of 75,000 samples, with a plan to continue testing as needed for the foreseeable future.

In addition, Quantigen agreed in March of 2021 to begin genetic variant surveillance using select CoV-positive samples taken from around the state. By performing whole-genome sequencing on these viral isolates and comparing them to a reference sequence, the ISDH can monitor the prevalence of variants with known clinical characteristics (e.g., the South African 501.V2). In addition, they can quickly detect and monitor other novel variants that might potentially (a) cause more severe illness, (b) spread more readily, and/or (c) evade immune surveillance as primed by current vaccines. All variant information from these screens will be shared with the CDC, who will then use the data to help inform its guidance on appropriate public safety measures.

Respiratory Pathogen Testing

Coming soon…

Precision Medicine

Enterprise Pharmacogentics

Quantigen is pleased to offer the latest generation of pharmacogenetic testing to at-risk populations as part of its Enterprise PGx efforts. Working closely with Coriell Life Sciences, an established leader in personalized medicine, Quantigen seeks to improve population-wide health outcomes by ensuring that individuals are being prescribed safe, effective drugs at the proper doses.

To function properly, most pharmaceutical compounds require specific gene products known collectively as “drug metabolism enzymes” or DMEs. These enzymes either activate a compound upon ingestion, thereby readying it to do its job, or they inactivate a compound in preparation for excretion once that drug has performed its function. There are also gene products that help those drugs get to the right place in the body. However, natural variation in these genes translates to differences in how we respond to different drugs. For individuals with a particular variant, any drug dependent on the action of that gene’s DME product may prove ineffective or, in some cases, even toxic.

By testing for a comprehensive list of well-characterized genetic variants, individuals with a natural predisposition for altered drug metabolism can readily be identified. In turn, a careful review of that person’s current prescription regimen – examined in the context of his or her genetic profile – allows an experienced healthcare provider to offer appropriate replacement pharmaceuticals that will prove safe and effective. Dosing can also be adjusted for many medications, based again on the patient's genetics. Finally, drugs that are either redundant or potentially in conflict with one another (so-called “drug-drug interactions”) can also be modified.

The result? The patient enjoys better health outcomes, clearer explanations for why specific drugs have been prescribed, and fewer side effects – which together increase that individual’s willingness to adhere to his or her prescribed drug regimen. In turn, that person will feel better more of the time, make fewer trips to the doctor, and miss fewer days of work.

For more information on Coriell’s Corigen™ program for offering subscriber population analytics and associated cost savings, please visit:

Corigen™ at a Glance | Coriell Life Sciences.

Microsatellite Instability (MSI) Oncology Testing

Coming soon…

Stockholm 3 Prostate-Cancer Testing

Coming soon…