ADVANCE^®and PancreasDx^®
Clinical Decision Support

Identifying the underlying biological causes of symptoms can help direct therapy and guide medical management specific to the patient’s disease process. For example, genetic conditions such as hereditary pancreatitis and cystic fibrosis can both increase the risk of pancreatitis, but involve different treatments and clinical considerations. Early detection of the cause or causes of the disease process may prevent extensive diagnostic evaluations, delayed diagnosis and more severe end-stage disease.

Genetic testing for pancreatitis is recommended for individuals with pancreatitis that meet one or more of the following criteria:

• An unexplained episode of acute pancreatitis in childhood
• Recurrent acute or chronic pancreatitis without a known cause, particularly with early-onset
• A family history of pancreatitis of unknown cause
• A family history of pancreatitis with an established genetic cause
• Additional symptoms consistent with a genetic disorder that includes pancreatitis as a symptom, such as cystic fibrosis or a CFTR-related disorder

Additionally, individuals that meet any of the following criteria may also benefit from genetic testing:

• One or more attacks (or suspected attacks) of acute pancreatitis
• Abdominal pain after eating, chronic diarrhea, abnormal findings on a CT or MRI scan, or an abnormal laboratory test related to the pancreas

Ariel’s test goes beyond genetics to incorporate genetic testing, patient medical and family history, patient biomarkers, and up-to-date management considerations to provide a comprehensive and actionable precision medicine report.

PancreasDx tests for predisposition to both Mendelian (monogenic) and complex (multifactorial) forms of disease. A minority of pancreatitis patients have a monogenic cause of disease. Therefore, testing for predisposing risk variants in addition to monogenic disease variants assures a complete picture of known genetic predisposition.

PancreasDx^® is a comprehensive next-generation sequencing panel of genes related to susceptibility to pancreatitis and related complications.

ArielDx^® Lipid is a next-generation sequencing panel of genes related to genetic susceptibility to hypertriglyceridemia, a predisposing factor to pancreatitis. ArielDx^®Lipid is available as an add-on to PancreasDx^® during the ordering process.

Ariel is committed to a streamlined and convenient ordering and results disclosure process:

1. PancreasDx^® is a clinician-ordered test. To begin, create an account through the easy-to-use and secure Ariel online provider portal to place the order.
2. Once the order is placed, your patient will receive an email from Ariel inviting them to register online, sign test consent forms, access help resources, and complete their health profiles. 
3. A buccal swab kit will be mailed to your patient’s home. The patient will be provided with instructions to swab the inside of their cheek and return their DNA sample by mail.
4. Upon receipt of the DNA sample, completion of genetic testing and subsequent expert review of the findings, your patient’s test results will be released electronically through the secure Ariel portal. Clinicians and staff have a centralized area for managing different patient orders, requesting genetic counseling, and electronic release of results to patients.

Ariel offers educational materials on pancreatitis, genetic testing, complex disease and other pertinent topics for clinicians and patients inside the portal. Patient counseling materials for use during informed consent discussions and test ordering are available.

Ariel also offers genetic counseling services for patients through an independent third-party genetic counseling provider over video or phone. Pre-test genetic counseling through a third party is included as an option with every test, which clinicians can request with every order. A request for post-test genetic counseling can be made through the Ariel provider portal. At that time, the patient’s contact information and PancreasDx^® test results are provided to a third-party genetic counseling service. This third-party service will contact the patient to discuss cost and scheduling.

Yes. Ariel offers genetic counseling services for patients through an independent third-party genetic counseling provider over video or phone. Pre-test genetic counseling through a third-party is complimentary with every test, which clinicians can request with every order. A request for post-test genetic counseling can be made through the Ariel provider portal. At that time, the patient’s contact information and  PancreasDx^® test results are provided to a third-party genetic counseling service. This third party service will contact the patient to discuss cost and scheduling.

Mendelian, or monogenic, genetic variants are those traditionally associated with a high genetic risk for a disease or syndrome. Mendelian diseases for which pancreatitis is a feature include PRSS1-hereditary pancreatitis (autosomal dominant) and cystic fibrosis (autosomal recessive). However, Mendelian diseases are rare causes of pancreatitis. Instead, the etiology is typically complex. Multiple low-to-moderate impact risk variants have been associated with the development and progression of pancreatitis. Risk variants increase the risk for disease, but they are not considered to be causal in isolation. Instead, risk variants act in concert with other genetic and environmental influences. Pancreatitis research and clinical studies have shown that pancreatitis patients typically harbor several risk variants in combination with other environmental (e.g. tobacco, alcohol) or anatomic (e.g. pancreas divisum) risk factors.

Ariel reports both Mendelian and risk variants to provide a comprehensive picture of your patient’s genetic predisposition for pancreatitis and related complications. Although risk variants do not cause disease on their own, known associations with other variants, environmental or anatomic factors can provide insight into the etiology of a patient’s disease, thereby guiding future management strategies.

Ariel accepts all insurance plans. As a new provider, we are not considered an in-network provider with all insurance plans. While the organization continues to grow, Ariel will work towards establishing in-network status.

The Ariel team follows the process below:

1. When a physician orders PancreasDx the patient will receive a ‘Welcome’ email with a link to Ariel’s secure patient portal to register. During registration, they will be asked to provide their insurance information.
2. The Ariel team will contact the patient’s insurance to verify eligibility and benefits to assess potential costs for the patient. It is important to note that initial determinations from the patient’s insurance are subject to change, based on the patient’s clinical record and the discretion of the insurer.
3. Ariel’s billing team will contact the patient by phone to discuss benefits findings and the patient’s potential financial responsibility (i.e. co-pay, co-insurance, deductible). Ariel works with the patient’s insurance directly through the claims and appeals process. Our team will exhaust all efforts to obtain payment from the patient’s insurance plan to reduce or eliminate patient responsibility for the service. During the billing process, Ariel may ask the ordering provider to supply additional documentation to support the medical necessity of the service for your patient.

Ariel is required by law to bill patients for applicable co-pays, co-insurance, and deductibles, as directed by their individual insurance benefit plan. Ariel will partner with the patient to implement the most appropriate payback plan based on the individual’s financial need.

Depending on the patient’s insurance plan, there may be situations where Ariel is considered an out-of-network provider and the payment for our test will be sent to the patient directly. The patient is legally responsible for re-issuing that payment, with a copy of the Explanation of Benefits, to Ariel for processing.

To ensure that Ariel services are accessible to medically necessary patients, several options are available to support any patient out-of-pocket costs remaining after all billing efforts are exhausted with the insurance plan. Available options include payment plans, prompt pay discounts, and financial assistance, based on individual need.

Please tell your patient to expect an email from Ariel. Once you place an order in the secure portal, Ariel will send your patient a ‘Welcome’ email with a link to Ariel’s secure patient portal to register. The patient can then follow the instructions in their email to register in Ariel’s online portal, provide their insurance information and complete the informed consents and their patient profile. Once the requisite forms are compete, Ariel dispatches a DNA testing kit to the patient’s house. This kit also has all the necessary instructions for collecting the sample and shipping it back to Ariel.

The turnaround time for the test is approximately 4 to 6 weeks from the time the patient sample is received in our laboratory.