Physician FAQs

FAQ Table of Contents:

Please note that the ONCOblot has limited availability and we are not accepting new tests at this time.  If you would like to be updated on the availability of the test, please provide your contact information on the “Information Request” tab in our menu.

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Section One:  Description The ONCOblot test is…

Section Two:  Uses How ONCOblot can be incorporated into your practice

Section Three:  FAQ’s What physicians (and patients) want to know

Section Four:  Logistics  How to administer the test (Kit, Blood Draw, Shipping, Find a Lab, etc.)

Section Five:  Results What the results include, timing, examples



Watch our 3 minute video for an overview of ENOX2 and how ONCOblot® works.

Section One: Description — The ONCOblot® Test is…

The ONCOblot® test is a blood serum test that identifies the presence of cancer through the detection of ENOX2 proteins.  ENOX2 proteins are produced by cancer cells and these proteins are shed into the circulation.

The test uses two-dimensional gel electrophoresis and immunoblot analysis with an ENOX2 protein-specific antibody.  Each form of ENOX2 has a specific location on the blot which allows for identification of tissue of origin.

ONCOblot® can identify 25 tissues of origin in a single serum test.

Cancer screening is not an approved utility of the ONCOblot® test.  Therefore, it is not recommended for use in asymptomatic patients (patients with no cancer symptoms, patients with no other positive or suspicious diagnostic results, etc.)

ONCOblot® is a confirmation of cancer test which was made commercially available in 2013.  We are in the process of seeking FDA approval with a 510 (k) being prepared for submission.  The test currently meets FDA requirements for a Laboratory Developed Test (LDT).  Our laboratory is CLIA Registered (Clinical Laboratory Improvement Amendments) and CAP Accredited (College of American Pathologists).

Section Two:  Uses — How ONCOblot® can be incorporated into your practice.

How should ONCOblot® be used? When should I recommend the ONCOblot® test?

The ONCOblot test can provide additional insight and is complementary to other standard of care diagnostics.  It provides a non-invasive option to aid in the following:

      • Confirm cancer presence and tissue of origin
      • Identify cancers of unknown primary
      • Follow-up to other diagnostics and screening tests.  Such as:  abnormal mammograms, suspicious PET scans, high PSA, etc.
      • Monitor for recurrence
      • Post cancer treatment (2+ months post treatment completion)

Note:  ONCOblot is not recommended for use in asymptomatic patients (patients with no cancer symptoms, patients with no other positive or suspicious diagnostic results, etc.)

 

Please refer to Physician FAQ’s below for more specifics about using the ONCOblot® test.

Section Three: FAQ’s — What physicians (and patients) want to know.

What types of cancer does the ONCOblot® detect?

The database contains over 1,800 specimen containing examples of ENOX2 protein expression for the following cancers:

Bladder, Breast, Cervical, Colorectal, Endometrial, Esophageal, Follicular, Gastric, Hepatocellular, Kidney, Leukemia, Non-Small Cell, Lung Small Cell, Lymphoma, Melanoma, Mesothelioma, Myeloma, Ovarian, Pancreatic, Papillary, Prostate, Sarcoma, Squamous Cell, Uterine and Testicular Germ Cell.

Do the results reveal more than one type of cancer in one test?

Yes.  If there is more than one tissue of origin, then more than one type of ENOX2 would be revealed and the results would indicate each tissue of origin.

How does the ONCOblot® test compare to the other cancer blood tests?

Many cancer blood tests currently available measure elevated levels of normal physiological compounds that are always present in serum.  They are typically employed post clinical diagnosis. The ONCOblot® detects the presence of ENOX2.  ENOX2 is not a normal protein in the serum.  ENOX2 exists in serum when cancer is present.

Please note that there is a laboratory which has a similar name to our test and they perform a different blood test.  Our laboratories are not associated in any manner and the tests are completely different.  The ONCOblot® test is the only test that detects ENOX2–the answer is in the blot

Do the results provide stage of cancer?

No.  The results show either presence of ENOX2 or no presence of ENOX2.  There is no indication for level or stage.

Do the results show tumor burden? (Refers to the number of cancer cells, the size of the tumor, or the amount of cancer in the body. Also called tumor load.)

No. Circulating ENOX2 levels determined by ONCOblot®are not necessarily proportional to tumor burden.

Will the ONCOblot® test provide location of metastasis?

No. Because the metastasized cancer is derived from the primary tissue of origin, metastatic tumors and the primary tumors from which they are derived will produce identical ENOX2 isoforms.  Therefore, the metastasized cancer would be detected by the test, but the tissue of origin would remain the same as the primary. Example:  If breast cancer has metastasized to the lung, the test result would reveal only breast cancer since the tissue of origin of both tumors is breast tissue.

How soon may I administer the test once a patient has gone through treatment?

We recommend you wait a period of 2 months after the conclusion of treatment before drawing a serum sample for ONCOblot® analysis. The utility of the ONCOblot® test for monitoring the efficacy of treatment has not yet been determined.

In some cases, treatments such as radiation and chemotherapy may transiently reduce ENOX2 concentrations below the limit of detection of the ONCOblot® test, even though a significant number of cancerous cells are still present. Likewise, successful interventions may temporarily reduce the number of viable cancer cells below the number necessary to produce a sufficient amount of ENOX2 protein to be detected by the ONCOblot® test. Therefore, it is suggested that physicians wait for a period of 2 months after the conclusion of treatment prior to submitting a serum sample for analysis.

May I use the ONCOblot® test as a screen for cancer?

No.

A large-scale clinical trial to demonstrate the efficacy of ONCOblot® as a cancer screening test in asymptomatic patients has not been completed. Cancer screening is not an approved utility of the ONCOblot® Test.

Instead, the ONCOblot® test has utility for verification of the tissue of cancer origin, identification of cancers of unknown primary and confirmation of cancer recurrence.  Results are provided to medical professionals for interpretation.  The ONCOblot® test is a confirmatory test that is intended to be used by the ordering physician in conjunction with the patient’s complete medical history and the results of standard of care testing. Cancers progress at varying rates and therefore, the frequency of diagnostic testing is subject to the ordering physician’s clinical judgement.

May I use ONCOblot® during treatment to measure changes in levels of ENOX2?

No.  Results of the ONCOblot® test are qualitative, not quantitative.  The test reveals the presence of cancer and tissue of origin.  It does not reveal stage or tumor burden.  The ONCOblot® test does not provide a quantifiable amount or level of ENOX2 present at the time of testing.

Does the ONCOblot® detect cancer cells that are frequently produced and subsequently destroyed by the immune system?

  • No. There are far too few of these cells to produce a sufficient amount of an ENOX2 isoform to be detected.
  • The limit of detection of an ENOX2 protein is a concentration of 1.3 nM, which is estimated to be produced by 2 million cells (equivalent to a solid tumor of about 2 mm in diameter). For a solid tumor to produce enough of a single ENOX2 isoform to be detected, it is likely that such a tumor has already evaded early immune surveillance.
  • Of course, it is possible for the immune system to recognize and remove tumors of any size, if given the opportunity. This is the basis behind much of the recent advances in immunotherapies.

What is the sensitivity of the test?

Currently, the lower limit of detection is a concentration of 1.3 nM of an ENOX2 protein.  This amount is estimated to be about 2 million cancer cells in the body, equivalent to a solid tumor of approximately 2 mm in diameter.

The sensitivity and specificity of the ONCOblot® test for general cancer screening with individuals presenting with no symptoms of cancer has not yet been determined.   The results of the test are not intended to replace current standards of care.  As with any clinical test, a possibility of false positives or false negatives exists.  All results must be reviewed by a qualified physician to interpret the results in light of a patient’s symptoms, complete medical history and the results of other diagnostic tests in order to determine next best steps for the patient.

What if a patient has a positive ONCOblot® result, followed by negative pathology or subsequent diagnostic tests that do not indicate the presence of cancer?

  • The ONCOblot® test is ultra-sensitive and has been shown to detect the presence of cancer as early as Stage 0. It is estimated that as few as 2 million cancer cells (2mm cancer, roughly the size of a pinhead) may shed a sufficient amount of ENOX2 protein to be detected in blood serum. Because of this, it may be difficult to detect by normal pathology. Because cancers progress at varying rates, the frequency and necessity of diagnostic testing is subject to the ordering physician’s clinical judgment.
  • There is evidence that not all early cancers will progress to a stage where they become clinically relevant. However, it is seldom possible to predict which early cancers will be slow growing and which will be highly aggressive. A patient’s physician is always the best resource to help a patient decide upon the best treatment options based upon a patient’s medical history, the results of all of the patient’s diagnostic tests and the physician’s clinical judgement.

How frequently should a patient be tested with the ONCOblot®?

Because cancers progress at varying rates, the frequency and necessity of diagnostic testing is subject to the ordering physician’s clinical judgment based upon a patient’s medical history and the results of all of the patient’s diagnostic tests.

Is the ONCOblot® test a CTC (circulating tumor cell) Test?

No.  The ONCOblot® test detects the ENOX2 protein marker, which is shed into blood serum by cells after malignant transformation.  Note:  Physicians may use results from ONCOblot® along with other diagnostics, such as CTC’s, to gain additional insight into the patient’s health.

Does the test detect other cancers not listed as part of the database?

There are currently 25 cancers from 20 separate tissues of origin on the ONCOblot® database. This means that there are many cancers that are not represented in the ONCOblot® Database. These cancers will either produce ENOX2 protein transcript variants of cancers of the same or similar tissue of origin within the ONCOblot® database, or they may produce a completely different pattern of ENOX2 proteins. If a pattern of ENOX2 protein expression is found which does not fit a pattern of ENOX2 protein expression that is represented in the ONCOblot® database, then the result is returned as “Not In Database” or NIDB.

Does the test detect brain cancers?

We have analyzed serum samples from clinically-confirmed brain cancer patients. Although it is possible to detect ENOX2 proteins within the serum of these patients, the amount of ENOX2 detected within the blood serum of these patients appears to be lower than anticipated. This is most likely because ENOX2 shed from brain tumors traverses the blood/brain barrier and into circulation relatively slowly. The ENOX2 protein expression patterns of different brain cancers also appear to be quite varied. For these reasons, we do not include brain cancers within the list of cancers that are more easily detected by the ONCOblot® Test.

At what levels of PSA can the ONCOblot® test detect the presence of cancer?

In a case report being readied for publication, a 64 year male with a starting PSA of 0.8 ng/ml was followed longitudinally for 16 years using banked serum samples.   A positive ONCOblot® was first noted in year 8 when the subject’s PSA was 4 ng/ml.  Positive ONCOblots® were obtained in succeeding years as long as the subject’s PSA exceeded 4 ng/ml.

No clinical symptoms were recorded until year 16 (abnormal MRI, neuropathy, pathological fracture of right humerus).  Cancer was confirmed by biopsy in year 16 and the patient had a PSA of greater than 25 ng/ml and extensive metastases to the skeleton.

In this study a serum sample with a PSA of 4 ng/ml or higher registered an ONCOblot® positive for prostate cancer ENOX2 transcript variant.

How long has the test been available?

The ONCOblot® Test was made available in January 2013 by MorNuCo, Inc.  The MorNuCo laboratory is CLIA Registered and CAP Accredited.

What is the physician cost of the test?

Please email info@oncoblotlabs.com or call us at 972-510-7773.

Is the test covered by insurance or Medicare?

No.  The ONCOblot® test is not yet covered by insurance or Medicare.

How much is the test kit?

There is no charge for the test kits. Once we resume full availability of testing, kits may be ordered through this website.  Test kits must be ordered by a medical clinician only.

Is the test approved by the FDA?

We are in the process of seeking FDA approval with a 510 (k) being prepared for submission.  The test currently meets FDA requirements to be marketed as a Laboratory Developed Test (LDT).  Our laboratory is CLIA Registered (Clinical Laboratory Improvement Amendments) and CAP Accredited (College of American Pathologists).

Section Four: Logistics — How to administer the test (Kit, Blood Draw, Shipping, Find a Lab, etc.)

How do I obtain a test kit and then administer the test?

  • Order an ONCOblot® test kit (once we resume full availability of testing) which is sent to a physician’s office at no charge.
  • Kit contents include: Requisition Form, tiger top tube, transfer tube, specimen bag, icepack, paper towel, blood draw and shipping instructions, FedEx Clinical Pak and billable stamp.
  • Complete both sides of the Requisition Form.
  • Serum Collection Instructions:
    • Collect blood in a tiger top tube with serum separator, label tube with patient date of birth (DOB) and gender.
    • Invert tube 8 to 10 times.
    • Allow sample to stand upright at room temperature for 30 minutes to clot blood. Centrifuge sample for 15 minutes at 2500 RPM (serum should be free of hemolysis).
    • Aliquot serum into plastic transfer tube.
    • Label plastic transfer tube with patient DOB, gender and the unique identification number found on the requisition form.
    • Freeze the serum sample and ice pack. (Serum may be kept frozen indefinitely until able to ship.)
    • Return serum sample per instructions below.
  • Specimen Shipping Instructions:
    • Keep the Specimen Return Box to ship back the serum sample.
    • Place frozen serum sample & frozen ice pack in the specimen bag with paper towel included in kit.
    • Insert the completed Requisition Form into the outer pouch of the specimen collection bag.
    • Enclose specimen bag in the Specimen Return Box and close securely with tape.
    • Seal the Specimen Return Box inside the FedEx Clinical Pak.
    • Ship back the specimen box with sample and completed Requisition Form Monday – Thursday only to:

Mor-NuCo Laboratories
1201 Cumberland Ave, Suite B
West Lafayette, IN  47906

What are the requirements for the blood draw?

One tiger top tube of blood (included in the kit, 8.5 mL) should generate about 2mL of serum when spun.  In the case where a phlebotomist has difficulty drawing a full tiger top tube, we would need a final serum volume of 150 microliters. Size of needle does not affect the protein (butterfly needles work). There are no special diet or drug requirements prior to the blood draw.  The serum must be frozen and shipped with the ice pack (included in the kit) and shipped overnight to the lab Monday-Thursday only.  The serum can be stored frozen indefinitely prior to shipping.

How do I know when the laboratory actually received the test sample?

Confirmation of receipt will be sent to the prescribing physician to the email or fax provided on the Requisition Form. This confirmation is provided within 24 hours of receipt of the sample.

What if I don’t provide blood draws at my office? And, where can I find a lab to draw the blood?

Click here for options.

How long may I keep the serum prior to shipping?

The serum may be kept frozen indefinitely until you can ship the sample. Follow all instructions for the blood draw.  Separate the serum and freeze it in the transfer tube until sample can be shipped.  Include the frozen ice pack when you ship the serum sample.

Why should I only ship samples Monday-Thursday?

The lab is closed on weekends. Because samples are returned overnight, we don’t want the samples to arrive at the laboratory on a Saturday or Sunday. This is to ensure personnel are available to receive, sign for and properly store the samples.

*A pre-paid billable stamp for overnight shipping is included in the test kit*

Is it okay to draw the blood on a Friday since I should only ship Monday - Thursday?

Yes.  Since the serum may be kept frozen indefinitely, you may draw the patient’s sample on Friday and ship the serum on Monday. Follow all instructions for the blood draw. Separate the serum and freeze it in the transfer tube until the sample may be shipped.  Include the frozen ice pack when you ship.

Section Five: Results—What the results include, timing, examples

What information is provided in the results and what is the timing of results?

  • Results indicate if ENOX2 is present, or not. If ENOX2 is not detected, then there is no more information provided.  If ENOX2 is detected, the molecular weight (MW) and isoelectric point (pI) of each ENOX2 isoform detected are provided, which identify the tissue of origin most consistent with our database.
  • Sample PDF of results for both positive and negative results.
  • Results are sent to prescribing physician to the email or fax number provided on the Requisition Form.
  • Results take 15 business days (3 weeks) to process.

If I have questions about the results, who do I contact?

We encourage you to send an email to our physician consultant at info@oncoblotlabs.com or call 972-510-7773. We will contact you the same day or by noon CST the following business day.  If needed, we will be happy to schedule a follow up consult with our Laboratory Director.