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Research & Clinical

Clinical assays are not FDA cleared for in vitro diagnostic use.

Infectious Disease

HPV

The Rheonix HPV CARD is able to detect and distinguish 20 different clinically relevant HPV sub-types directly from cervical specimens, including distinguising infections by multiple sub-types. Close

Research indicates that virtually all cervical cancers are caused by HPV infections, with two particular strains responsible for almost 70% of all instances. Current FDA-approved HPV diagnostic tests can only distinguish between high–and low–risk HPV strains. The Rheonix HPV CARD is able to detect and distinguish 20 different clinically relevant HPV sub-types directly from cervical specimens, including distinguishing infections by multiple sub-types. Providing rapid, detailed results at a low cost will enable physicians to make course of treatment decisions and support the development of strain-specific therapies.
Path-to-market

Sepsis

The SeptiCARD can detect the presence of 150 sepsis agents, including C. albicans, E. coli and enterococcus, within a three-hour period directly from 5 ml of whole blood, resulting in potential life-saving diagnoses. Close

The rate of sepsis mortality increases approximately 8% for every hour the disease goes undiagnosed. The current method to detect sepsis agents can take days because it relies upon blood cultures for diagnosis. The SeptiCARD can detect the presence of 150 sepsis agents, including C. albicans, E. coli and enterococcus, within a three-hour period directly from 5 ml of whole blood, resulting in potential life-saving diagnoses.
Path-to-market

STI

The STI CARD is unique in that it is able to simultaneously detect the STI agents responsible for gonorrhea, chlamydia, syphilis and trichomoniasis directly and automatically from urine. Close

Sexually transmitted infections (STIs) are often curable. Unfortunately, many go unnoticed in the early stages of infection leading to much more serious consequences when left untreated. The STI CARD is unique in that it is able to simultaneously detect the STI agents responsible for gonorrhea, chlamydia, syphilis and trichomoniasis directly and automatically from urine. The STI CARD assay is a low-cost, easy-to-use test adaptable to both industrialized and developing nations for diagnosis of STIs at an early stage as part of routine screening.
Path-to-market

HIV

Rheonix has created the HIV CARD with the ability to simultaneously run a screen and confirmatory assay on the same consumable. Close

HIV is one of the world's leading killers; yet less than half of people who are infected globally know their HIV status. With new advancements in HIV therapies, patients can enjoy healthy and productive lives. Rheonix has created the HIV CARD with the ability to simultaneously run a screen and confirmatory assay on the same consumable. The product can identify both antibodies against HIV and HIV RNA from saliva samples, providing an instant confirmatory test to patients and reducing the number of false positives.
Path-to-market

UTI

The UTI CARD is able to diagnose UTIs with strain specificity directly from urine in a three-hour period on an easy-to-use instrument. Close

Urinary tract infections (UTIs) are common and easily treated with antibiotics; however, complications can occur if the infection spreads to the kidneys. Current UTI diagnosis is performed by urinalysis to determine the presence of an infection followed by a urine culture to determine the specific bacterial strain present, which ensures the correct antibiotic is given. Both tests require specialized training and time, whereas the UTI CARD is able to diagnose UTIs with strain specificity directly from urine in a three-hour period on an easy-to-use instrument.
Path-to-market

Pharmacogenomics

Warfarin

The Warfarin PGx Assay provides clinicians with sufficient genomic data to determine appropriate therapeutic doses of warfarin. Close

Warfarin is a widely prescribed anticoagulant, but finding the right dosage can require weeks of trial and error often resulting in incorrect dosing and dangerous adverse events in patients with genetic predispositions. The Warfarin PGx Assay provides clinicians with sufficient genomic data to determine appropriate therapeutic doses of warfarin. The assay automatically detects three specific single-nucleotide polymorphisms (SNPs) associated with warfarin dosing sensitivity from whole blood and has the potential to drastically reduce the number of adverse events that occur with the trial and error dosing method.
Path-to-market

Clopidogrel (Plavix®) Sensitivity

The Clopidogrel PGx Assay is able to detect the patients at risk for clopidogrel sensitivity, providing physicians with imperative knowledge when prescribing this drug. Close

Clopidogrel is an anti-platelet drug used in the prevention of strokes and heart attacks. Researchers have found that certain genetic variations put some patients at more than three times higher risk for a major adverse cardiovascular event when taking clopidogrel. The Clopidogrel PGx Assay is able to detect the patients at risk for clopidogrel sensitivity, providing physicians with imperative knowledge when prescribing this drug.

Plavix® is a registered trademark of Sanofi–Aventis.
Path-to-market

KRAS-BRAF

The KRAS CARD is able to automatically process both fresh and FFPE (formaldehyde fixed-paraffin embedded) samples, amplify, and detect the somatic mutations associated with reduced drug therapy effectiveness. Close

Patients undergoing cancer therapy are commonly screened for the biomarkers KRAS and BRAF to predict the effectiveness of anti-EGFR drug therapy. Tumors with mutated versions of KRAS and BRAF are less likely to respond to such therapies; therefore, physicians use KRAS and BRAF status to determine treatment options. The KRAS CARD is able to automatically process both fresh and FFPE (formaldehyde fixed-paraffin embedded) samples, amplify, and detect the somatic mutations associated with reduced drug therapy effectiveness.
Path-to-market