Boston An independent LDT provider

Frequently asked questions

What is the sensitivity and specificity of the IMMray® PanCan-d test?

The IMMray PanCan-d test has a specificity of 99% and a sensitivity of 89% in stages I and II PDAC, and a specificity of 99% and sensitivity of 92% in stages I – IV PDAC.

What is the negative predictive value (NPV) and positive predictive value (PPV) of the IMMray PanCan-d test?

Assuming a prevalence of 1%, the NPV of the IMMray PanCan-d test is 99.9% for stages I and II PDAC and 99.9% for all stages, and the PPV is 47.3% for stages I and II and 48.2% for all stages.

Assuming a prevalence of 3%, the NPV is 99.7% for stages I and II and 99.8% for all stages, and the PPV is 73.4% for stages I and II and 74.0% for all stages.

How do I get an IMMray PanCan-d test requisition?

You can download the IMMray PanCan-d Test Requisition here.  Contact Customer Support at 833-593-9522 for assistance or to request a printed version to be mailed to you.

How do I order the IMMray PanCan-d test? Can I order it through my EHR system?

The IMMray PanCan-d test can be ordered by:

1) Faxing the Test Requisition to our laboratory at (888) 466-7298

2) Submitting via the Immunovia, Inc. online portal

The IMMray PanCan-d test currently cannot be ordered within an EHR system. It must be ordered via fax or through the Immunovia, Inc. provider portal.  You can request access to the provider portal by completing this form and once registered, you can access to the provider portal here.

How is my patient’s blood sample collected for the IMMray PanCan-d test?

Patients can have their blood drawn for the IMMray PanCan-d test either by having a certified phlebotomist come to their home or office, or by going to an ExamOne or Any Lab Test Now office location. The sample is collected in a red top glass tube supplied by Immunovia, then allowed to sit for 45 to 60 minutes to allow clots to form. It is then centrifuged for 10 minutes at 1300xg. A pipette (also provided by Immunovia, Inc.) is then used to move the serum into microcentrifuge tubes, which is how it is transported to Immunovia, Inc. for processing.

Can I collect the blood sample for the IMMray PanCan-d test in my office?

It may be possible for you to collect the IMMray PanCan-d serum sample in your office. Please speak with your local Immunovia, Inc. sales consultant or contact Customer Support at 833-593-9522 for additional information.

Where does my patient’s serum sample need to be sent for processing?

All serum samples are processed at Immunovia, Inc. located at 26 Forest St, Suite 110, Marlborough, Massachusetts 01752. Samples are shipped via FedEx® Priority Overnight in NanoCool® packaging to make sure the serum stays between 4 and 8°C during shipment.

What happens if the serum sample is lost or delayed en route to the laboratory?

In the unlikely event that a patient’s serum sample is lost or delayed during shipment, Customer Support will schedule another draw for that patient. The patient will not be charged for any portion of the cost associated with the lost or delayed sample, and will only be charged when a valid test result is reported.

Is my patient able to receive their test results directly?

All patient result reports are sent to the ordering physician, who will then share the results with the patient.

How do I access the IMMray PanCan-d results for my patient?

Physicians can decide if they want results faxed to their office, or if they would like to access them via the provider portal.

What information is included in the test results? Why are CA19-9 levels also reported in the test result?

IMMray PanCan-d results include: High-Risk Signature Present, Negative for High-Risk Signature, or Borderline (where a patient’s sample result is close to the cutoff and could not be assigned a High-Risk Signature Present or Negative for High-Risk Signature result with greater than 90% confidence). The IMMray PanCan-d test uses CA19-9 levels in its algorithm, so CA19-9 levels are also reported in the result.

What is the turnaround time for the IMMray PanCan-d test?

Once Immunovia, Inc. receives a patient sample, it takes 5 to 7 business days for a result to be sent to the ordering physician.

My patient received a result of “High-Risk Signature Present” with the IMMray PanCan-d test. What does that mean?

A result of High-Risk Signature Present with the IMMray PanCan-d test indicates that the patient’s sample was classified as “high risk” based on the analysis of 9 serum biomarkers (including CA19-9) using a predetermined risk stratification algorithm.  While this assay is highly accurate, its results must be evaluated in light of both clinical findings and the patient’s family and genetic histories in order to reach optimal care decisions.

What does a “Borderline” result for the IMMray PanCan-d test mean?

The Borderline finding indicates that the sample result is close to the cutoff and could not be assigned a High-Risk Signature Present or Negative for High-Risk Signature result with greater than 90% confidence. Sample quality was adequate. Retesting with a new sample may clarify the results for this patient.  Typically, less than 10% of samples analyzed yield a borderline IMMray PanCan-d result.

What does a “Test Not Performed” result for the IMMray PanCan-d test mean?

A result of Test Not Performed means that Immunovia, Inc. was unable to process the specimen in our lab, usually because of the quality of the specimen. This can be caused by shipping delays, or conditions during travel where the specimen temperature increased above 8°C.

Is my patient charged for a “Test Not Performed” result?

No. Patients are only charged for IMMray PanCan-d tests that are processed and provide a valid result of High-Risk Signature Present, Negative for High-Risk Signature, or Borderline.

Will I see the measures of individual biomarkers reported in the IMMray PanCan-d test results?

No. With the exception of CA19-9, the individual biomarker measures are not included in the patient result report.

How much does the test cost? Is it covered by insurance?

The IMMray PanCan-d test is only available via patient pay as we seek insurance coverage. The list price of the IMMray PanCan-d test is $995.

Patients may also be able to use flexible spending accounts (FSAs) or health savings accounts (HSAs) to pay for the IMMray PanCan-d test.

Contact our Customer Support team for additional information, including payment plan options and prompt pay discounts, at 833-593-9522 between 8 AM and 5 PM Eastern Time.

Do you have financial assistance programs for patients?

Yes, Immunovia, Inc. has a number of financial assistance programs including a prompt pay discount, interest-free payment plan options, and hardship programs.  Contact Customer Support at 833-593-9522 for more information.

Who should I contact with questions about my patient’s results?

Questions regarding a specific patient’s results should be directed to Dr. Thomas King, Immunovia, Inc.’s Medical Director. General questions about the test, or logistics about the test, can be directed to Customer Support at 833-593-9522.

I am having trouble accessing the portal to order a test or to download my patient results. Who do I contact?

If you encounter any issues with the Immunovia, Inc. provider portal, please contact Customer Support at 833-593-9522.