OUR GENOMIC SEQUENCING

Tempus Tests Available in the Program

We’ve built a state-of-the-art, CAP-accredited and CLIA-certified lab. Our highly robotic laboratory is optimized for high-throughput clinical next-generation sequencing with a current capacity of over 100,000 patients annually.

xT Solid Tumor + Normal Test

FEATURES

648 gene DNA panel sequenced at average 500x depth of coverage

Sequencing of FFPE tumor tissue and normal matched (through blood or saliva) specimens; includes reporting of 46 incidental germline findings

MSI Status and Tumor Mutational Burden (TMB)

Full transcriptome by RNA sequencing (including CAP/CLIA-validated identification of relevant fusions)

SPECIMEN TYPES

FFPE tissue slides or blocks
Normal matched (blood or saliva)

xT Tumor Only Test

FEATURES

648 gene panel sequenced at average 500x depth of coverage

MSI Status and Tumor Mutational Burden (TMB)

Full transcriptome by RNA sequencing (including CAP/CLIA-validated detection of relevant fusions)

SPECIMEN TYPES

FFPE tissue slides or blocks

Recommended when unable to obtain normal matched specimen or if the normal matched specimen cannot be successfully sequenced

Note: All additional tests ordered beyond xT will be billed to insurance.

OUR PROCESS

Steps for physician ordering.

  1. Receive a collection kit. All required forms are contained in the kit. To order new kits, please contact your local Tempus sales representative, email support@tempus.com, order online through the Tempus portal or call 800.739.4137, option 1.
  2. Complete the test requisition form online or on paper. Please take the following guidance:
    • Associated Study: Write in promo code “BAYER2020”.
    • Panel Test Options: Select xT Solid Tumor + Normal OR xT Solid Tumor Only testing.
    • Billing Information: Does not need to be filled out unless tests other than xT are ordered.
    • Current Diagnosis: Ensure this section is filled out and reflects eligibility for the program (Metastatic colorectal cancer (mCRC) with high Microsatellite Instability (MSI-H) status or patients with radioactive iodine refractory differentiated thyroid carcinoma (RAIR DTC)).
  3. Submit the requisition form and any accompanying documents via online portal, email to support@tempus.com, fax 800-893-0276, or include in the kit.
    • The BAYER2020 promo code must be included on the requisition form.
    • Demographic sheet.
    • Clinical data (most recent progress notes).
    • Pathology report.
    • Once the requisition form is received, Tempus will request the tumor specimen from pathology.
  4. Indicate on the requisition form the preferred method for collecting the normal sample.
    • If the patient is available in the office, collect the normal sample using instructions in the kit.
    • For at-home collection options, email support@tempus.com or contact your local representative.
  5. Await results while Tempus procures specimens, sequences, and generates the patient’s report. Reports are delivered in approximately 10-14 days from the time Tempus has received all the required information and the specimen(s).

QUESTIONS

Frequently asked questions

What test will be run?

Eligible patients will receive Tempus’ xT solid tumor assay with 648 genes, tumor/normal matched (when a normal is available) and whole transcriptome RNA sequencing. All genomic alterations are clinically validated and identified through DNA and RNA. Tumor/normal match results are only available when a normal sample has been provided.

What are the specimen requirements?

Solid Tumor Tissue Requirements:

  • Tumor samples should be from the most recent procedure
  • FFPE Fixation requirements:
  • Tumor required to be at least 20% of the sample by ratio of tumor nuclei to benign nuclei
    • 10% formalin (neutral buffered) for 6-72 hours, paraffin embedded
    • Specimens decalcified in EDTA are accepted, acid decalcified specimens are not accepted
  • Tumor required to be at least 20% of the sample by ratio of tumor nuclei to benign nuclei
  • 1 FFPE tissue block or 10 FFPE tissue slides + 1 H&E slide
  • Normal Sample Requirements:
    • 8 ml of blood
    • 500 µl of saliva

When can I expect results?

Results will be available in the Tempus clinical portal 10-14 days after sample receipt. If patients are found to have an NTRK fusion, the physician will additionally receive a notification and information on a treatment that may be appropriate for the patient.

Decisions related to patient care and treatment choices are made based on the independent judgment of the treating physician and should take into account all information related to the patient.

Which patients are eligible for the program? (Diagnosis, Insurance)

US-based patients with metastatic colorectal cancer (mCRC) with high Microsatellite Instability (MSI-H) status or patients with radioactive iodine refractory differentiated thyroid carcinoma (RAIR DTC). This should be noted in the diagnosis section of the requisition form. By adding BAYER2020 to the requisition form and signing the requisition form, the ordering physician is confirming that the patient meets the eligibility criteria. Tempus will reach out for billing information if the patient does not meet eligibility criteria.

What type of insurance does my patient need? Will there be any cost to the patient?

There is no insurance required for xT testing offered through this program. Bayer will cover the cost of the Tempus xT test, and Tempus will not bill the patient or the patient’s insurance for the test. Any additional tests that are ordered would be billed to insurance.

How do I enroll my patient?

Please see our Steps for Physician Ordering above. 

How do I order a kit?

Please contact your local sales representative, email support@tempus.com, order online through our Tempus portal or call 800.739.4137 option 1.

What if I get a bill?

Tempus will not bill for the testing conducted under this program. Please email support@tempus.com or call 800.739.4137 option 1 with any billing questions.

If the solid tumor test fails, can we convert to liquid biopsy?

This Bayer sponsored testing program only covers the Tempus xT test. However, if the tumor tissue sample fails and the physician would like to convert to Tempus’ xF liquid biopsy test, patient insurance will be requested and billed.