What is IQIsolate?
IQIsolate is a proprietary process that measures gene expression patterns in whole blood. Using gold standard approaches widely adopted in the molecular laboratory industry, RNA expression patterns are quantified to determine the extent to which a particular gene is turned on or turned off. The genes examined through our research show distinct expression levels across healthy subjects and patients with autoimmune or related conditions. The IQIsolate process is able to distinguish subtle differences in RNA expression levels indicative of healthy or diseased patients and provides clinicians with actionable information to confirm a suspected diagnosis.
What are the Isolate tests?
The Isolate tests include IsolateMS, IsolateIBS-IBD, and IsolateFibromyalgia. These tests leverage the IQIsolate process to decipher real-time disease activity in a patient’s blood sample. Specific patient RNA expression patterns are analyzed and compared to both healthy and diseased subjects. These results are then transformed into a simple yes or no outcome for each specific autoimmune condition. This actionable information provides clinicians with crucial test results identifying the current disease state. Earlier determination of disease allows for clinicians and patients to develop a treatment regimen to halt disease progression.
What is the difference between RNA and DNA?
Alterations in DNA sequences have been studied and documented for decades, but the presence of changes in DNA do not necessarily result in the manifestation of disease. RNA molecules carry out the instructions found in our DNA. Given that the vast majority of our genome is transcribed into RNA, there is a great deal of information communicated in the cells of the human body. IQIsolate harnesses information found in a portion of this ‘molecular conversation’ by measuring RNAs that exhibit significant changes across multiple disease types including autoimmune and non-autoimmune patient populations.
What does RNA reveal that can't be obtained some other way?
IQIsolate and the Isolate tests provide clinicians with information not currently available. Analysis of the RNA found in blood provides a real-time snapshot of what is taking place in a patient’s immune cells. Using machine learning to analyze thousands of patient samples, IQuity accurately identifies whether a patient has a specific disease or condition. In autoimmune diseases, like multiple sclerosis, RNA signatures are detectable at the earliest stages of the disease. IQIsolate may allow a patient to avoid tissue damage that typically occurs prior to diagnosis using current conventional methods.
Which specific RNA levels indicate a person has a particular disease?
The genes measured can be over or under expressed at various stages of disease progression. The IQIsolate process is able to discern even small changes in RNA expression levels. The specifics are proprietary and developed from a cohort of more than 2,500 test subjects.
Could a patient have a 'yes' result and not have the disease?
It is unlikely – IQuity’s research determined and validated that the genes measured are specific to the suspected disease and not to other diseases or healthy people.
How early in the disease progression can disease be detected?
Using the IQIsolate process, we are able to detect presence or absence of disease at the earliest sign of symptoms.
How is an Isolate test panel run?
The provider, or a designated phlebotomist, collects blood into a special PAXgene tube that is sent to IQuity’s CLIA-certified laboratory. RNA is first isolated from the patient’s blood and analyzed using real-time PCR (qPCR), the gold standard for measuring gene activity. IQuity’s proprietary algorithm is applied to the results to determine if the pattern is consistent with the specific disease or condition. Our laboratory delivers a result to the provider in as little as seven days.
How is RNA isolated from whole blood?
IQuity uses Preanaytix PAXgene tubes. The PAXgene Blood RNA System consists of a blood collection tube (PAXgene Blood RNA Tube) and a nucleic acid purification kit (PAXgene Blood RNA Kit). It is intended for the collection, transport, and stable storage of RNA in a closed tube derived directly from the blood. This allows for subsequent isolation and purification of intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing.
How were the Isolate tests validated?
The Centers for Medicare and Medicaid (CMS) regulate all laboratory testing performed on humans in the US through the Clinical Laboratory Improvements Amendments (CLIA). To be formally validated through CLIA, the test must meet CLIA-established standards related to analytical accuracy, sensitivity and specificity, as well as result reproducibility, and specimen collection stability. Additionally, the fundamental science on which the IQIsolate test platform is predicated was validated through the scientific rigor necessary to achieve publication in several academic peer-reviewed journals and presentations.
How does IQuity arrive at a definitive 'yes' or 'no' result?
Thousands of subjects at various stages of disease, as well as healthy subjects were studied for more than a decade to develop the IQIsolate process. Analyzing RNA patterns across multiple diseases led to the creation of a suite of algorithms, informed through machine learning, which support the analysis of a patient sample. An individual patient’s profile is compared to a robust database of other patient samples obtained through research efforts conducted by IQuity. The current tests deliver an accuracy rate greater than 90 percent.
What does the 'Yes' or 'No' result mean?
The test results indicate that the patient has an RNA expression pattern consistent with that of subjects who have been diagnosed with a given disease (Yes) or not (No).
Are the Isolate tests covered by insurance?
Not at this time. New diagnostics, as well as therapeutics undergo a time consuming process of securing reimbursement that can take years. IQuity is actively pursuing reimbursement.
What assistance is available for patients who can't afford the test?
IQuity is committed to making the Isolate tests available to as many patients as possible. The company offers significant discounts to patients who qualify.