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Frequently asked questions

What is the IMMray® PanCan-d test?

The IMMray PanCan-d test is a blood test for the early detection of pancreatic ductal adenocarcinoma (PDAC). In a blind validation study performed at Immunovia, Inc. in Marlborough, Massachusetts, the IMMray PanCan-d test was able to identify Stage I & II PDAC (n=56) versus high-risk individual controls (enrolled in a familial/hereditary pancreatic cancer surveillance program (n=187) with 99% specificity and 89% sensitivity. Across stages I – IV PDAC (n=157), the sensitivity increased to 92% with 99% specificity.

IMMray PanCan-d is not intended to be a general screening tool; it should only be used in patients at risk for developing PDAC.

How does the IMMray PanCan-d test work?

Eight specific biomarkers relevant to pancreatic ductal adenocarcinoma (PDAC) are printed onto a single microarray, with 14 microarrays per slide. A patient’s serum sample is then placed on the microarray and the patient response to each antibody is measured using a fluorescence scanner. The patient’s CA19-9 level is measured separately on the Roche Cobas instrument. The individual measurements of each biomarker and the CA19-9 levels are then entered into an advanced algorithm to come up with a result of High-Risk Signature Present, Negative for High-Risk Signature, or Borderline.

Is the IMMray PanCan-d test FDA approved?

No, the IMMray PanCan-d test is not FDA approved. The IMMray PanCan-d test is a laboratory developed test (LDT).

What is a laboratory developed test (LDT)?

A laboratory developed test (LDT) is “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory” as defined by the FDA. All IMMray PanCan-d samples are processed at Immunovia, Inc. in Marlborough, Massachusetts.

Where is the test processed?

IMMray PanCan-d specimens are all processed at Immunovia, Inc. in Marlborough, Massachusetts.

Can another lab run the IMMray PanCan-d on its own?

No, as a laboratory developed test, IMMray PanCan-d can only be run within a single laboratory. As a result, all specimens are processed at Immunovia, Inc. in Marlborough, Massachusetts.

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.

Reference: Brand RE, Persson J, Bratlie SO et al. Detection of early-stage pancreatic ductal adenocarcinoma from blood samples: Results of a multiplex biomarker signature validation study. Clin Transl Gastroenterol. 2022;13(3):e00468. (Open access)

How can detecting pancreatic ductal adenocarcinoma (PDAC) earlier improve outcomes?

80% of patients with PDAC are diagnosed with late-stage disease and do not qualify for surgery, which today is the only potential cure for PDAC. Symptoms of PDAC are vague (back pain, abdominal pain, nausea and vomiting, unintended weight loss, change in stool and/or urine) and often appear with later-stage disease. In addition, imaging of the pancreas is difficult because of its location in front of the spine and behind the stomach, so finding small tumors within the pancreas is difficult. As a result of the difficulty diagnosing pancreatic cancer at early stages, the 5-year survival rate is just 11%, the lowest of any cancer type. Diagnosing pancreatic cancer at stage 1, when the tumor is resectable, increases the 5-year survival rate to 49%, providing much better odds for long-time survival.  (Matsuno S, Egawa S, Fukuyama S et al. Pancreatic cancer registry in Japan:20 years of experience. Pancreas. 2004;28:219-230.)

What is the CLIA certification number for Immunovia, Inc.?


Is the IMMray PanCan-d test available in every state?

The IMMray PanCan-d test is currently available in most states, but it is not yet approved for individuals who reside in New York.

Is Immunovia, Inc. CAP accredited?

Yes, Immunovia, Inc. is accredited by the College of American Pathologists (CAP).

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