Ordering A Test

The GCC-B1 Blood test can now be performed at our laboratories. TDT has been certified under the Federal Clinical Laboratories Improvement Amendment of 1988 (CLIA ’88) for high–complexity laboratory testing and by the Commonwealth of Pennsylvania to perform high-complexity RNA-based testing.

If interested in the lymph node test, please click on the “Contact TDT” link below. We will alert you as soon as we receive regulatory approval.

Under CLIA ’88 guidelines, patient blood specimens are drawn and sent to our clinical reference lab for testing. The order form must be signed by both the patient and the physician, but results are reported directly back to the ordering physician. Under the statutes, TDT is required to report only to the ordering physician.

Order Forms can be obtained in several ways:

  1. Telephone Order - Physicians can call 1-800-431-0689 and we will fax or mail the test Order Forms directly to them, along with appropriate literature and instruction materials. Physicians can then complete the form and mail or fax the order back to us for processing. Please note that the order form must be signed by the physician and the patient.
  2. Mail/Fax Order -Physicians (or Patients) can download and print the forms by clicking on the appropriate test below. Although patients are free to download and print the forms, they must bring these forms to their physician to initiate the order process. Once the Order Form(s) have been completed by the physician, they can be mailed or faxed to us for expedited handling. Please note that the order form must be signed by the physician and the patient.

    The Order Form will direct us to send specimen collection kits to the patient or laboratory designated by the physician for drawing the blood sample.

Blood Collection Kits

Special kits have been developed to expedite the process of collection and shipping patient samples to our laboratory for testing. A completed order form signed by both the patient and physician is required. The collection kit will then be sent to the patient or lab designated by the physician. The collection kit contains all of the materials, direction inserts and labels required for obtaining and return shipping the sample.

Payment:

TDT is not a participating Medicare or Medicaid provider and does not bill either of these programs for the costs associated with these tests. TDT will provide the patient with the standard information required by insurance companies for reimbursement. The patient may elect to submit these materials and may receive full, partial or no reimbursement from his or her health care insurer. The patient must agree to assume full and direct responsibility for payment to TDT, Inc. for identified services. This payment process must be completed at the time of ordering. Subsequent reimbursement from any national or private insurance programs will be their sole responsibility.

Test Results:

Upon receiving patient specimens, TDT will process and assay the sample for the presence of GC-C mRNA and report the results directly back to the ordering physician. These results are supplied on a standard reporting form.

The GCC-B1 blood test detects messenger RNA from GC-C cells in peripheral blood. The result form provides a normal range expressed in copies of mRNA detected in the specimen. Detection of GC-C mRNA greater than the normal range may indicate the presence of metastatic disease. Your physician may decide to order additional blood and or imaging tests (X-Ray, CT, PET) to locate the source of metastases.

Since this is a new technology that is being launched in the United States, your physicians may not yet be aware of these tests. We encourage you to discuss these tests with them and would be happy to answer any questions they may have.

Test Results may be obtained by the physician:

  • Via email direct to the email specified on the order form
  • Via fax direct to the number specified on the order form
  • Via mail
  • Via phone by ordering physician with UPIN#

GCC-B1 Blood Collection Kits include blood collection tubes, a collection set, patient identification labels and prepaid return shipping materials.

To view the Order Form, you will need version 4.0 or later of Acrobat Reader installed on your computer. This is free software, and can be downloaded from Adobe by clicking on the Acrobat Reader image or this link.