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ONCOLOGY PARTNERSHIPS

Lilly Lung Cancer NGS Program with Tempus xT

No-cost, comprehensive next-generation sequencing for eligible mNSCLC patients

Lilly is sponsoring Tempus sequencing to reduce disparities in biomarker testing. Through this program, Lilly is offering no-cost, comprehensive next-generation sequencing (NGS) for eligible advanced or metastatic non-small cell lung cancer (NSCLC) patients. Research demonstrates that ~47% of patients with lung adenocarcinoma have an actionable genomic alteration and may benefit from appropriate targeted therapy.1 Only ~50% of metastatic NSCLC patients in community practices are consistently being tested for the five common biomarkers ALK, BRAF, EGFR, PD-L1, and ROS1.2

There is no obligation to order any other Lilly or Tempus product or service in order to participate in the sponsored test program. To enroll a patient, please use the program requisition form and follow the steps below.

  1. Hirsch, F., et al. (2017). Lung cancer: current therapies and new targeted treatments. Lancet, 389(10066), 299-311. DOI: https://doi.org/10.1016/S0140-6736(16)30958-8
  2. Robert et al., ASCO 2021, J Clin Oncol, 39, 2021 (suppl. 15, abstr 9004)

View Frequently Asked Questions

Why is Lilly sponsoring testing?

  • In an effort to reduce disparities and increase access to comprehensive biomarker testing, Lilly is providing no-cost comprehensive next-generation sequencing (NGS) for eligible patients.
  • The full cost of the test is covered regardless of test results or treatment decisions. Patients, healthcare providers, and insurance companies will not be billed.
  • Data collected through this program is not used for sales or marketing purposes or to encourage physicians or patients to  order products or services from Lilly or Tempus.
  • Healthcare professionals and patients who use this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use or support any Lilly or Tempus products or services.

Will there be any cost to the patient?

No. No eligible patient, nor their clinicians or beneficiaries, will be billed for the xT, xF reflex, or PD-L1 testing offered through this program. Tempus will not bill the patient or the patient’s insurance for the test.

What patients are eligible?

  • Patient has advanced or metastatic NSCLC
  • Patient lives and receives treatment in the United States or a U.S. Territory (including Puerto Rico, Guam, and Marshall Islands)
  • Patient does not have a known molecular biomarker from a previous test
  • Patient has not had prior comprehensive biomarker testing
  • Patient has not previously been tested under this program

Which Tempus Tests Available in the program?

xTSolidTumor + NormalTest

  • Features:
    • 648 gene DNA panel sequenced at average 500x depth of coverage
    • Sequencing of formalin-fixed, paraffin-embedded (FFPE) tumor tissue and normal matched blood specimens; includes reporting of 46 incidental germline findings
    • MSI status and Tumor Mutational Burden (TMB)
    • Full transcriptome by RNA sequencing (including CAP/CLIA validated detection of fusions)
  • Specimen Types:
    • FFPE tissue Slides or Blocks
    • Normal matched blood sample

Note: If a normal sample is not received, xT Tumor Only test will be run.

xF Liquid Biopsy Test
will only be used as a reflex/conversion test when tumor specimen cannot be successfully sequenced and a normal sample has been submitted

  • Features:
    • 105 gene panel sequenced at average 20,000x coverage depth (at least 5,000 duplicated reads)
    • Detects cell-free DNA (cfDNA)
    • CapableofassessingSNVs, CNVsandchromosomalrearrangementsinasubsetofgenes, andMSIstatuswhendetected
  • Specimen Types:
    • Streck tubes of peripheral blood

PD-L1 22C3 IHC Test
can be omitted if physician prefers

  • Specimen Types:
    • 3 additional FFPE tissue Slides or Block(s)

Note: The program is limited to the tests specified above, and a program requisition form must be used to participate in the program.

How do I enroll my patient?

Steps for Physician Ordering or xT Solid Tumor + Normal Test:

  1. Download the program test requisition form
  2. Complete the program test requisition form electronically or on paper
  3. Receive a blood specimen collection kit. To order new kits, please contact your local Tempus sales representative, email support@tempus.com, or call 800.739.4137, option 1
  4. Collect the normal blood sample from the patient using instructions in the kit. Note, if blood is not received, Tempus will proceed with tumor-only testing.
  5. Submit the program requisition form and any accompanying documents (most recent progress notes, pathology report) inside the kit or via email to support@tempus.com or fax 800-893-0276
  6. Send the blood kit with a copy of the program test requisition to Tempus using the pre-paid collection kit envelope
  7. Once the requisition form is received, Tempus will coordinate with the local laboratory to ensure the patient tissue sample is submitted
  8. Test results will be posted via the Tempus Clinical Portal 10-14 days after receipt of patient tissue sample and all required information*

*For new Tempus users, you will be granted access to the Tempus Clinical Portal for results after you submit your first order

What are the specimen requirements?

Solid Tumor Tissue Requirements:

  • Tumor samples should be from the most recent procedure
  • FFPE Fixation requirements:
    • 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
  • For PD-L1 22C3:
    • 3 additional FFPE tissue slides or a block

Normal Sample + xF Liquid Biopsy Requirements:

  • 2 Streck tubes of 8.5 ml of blood (provided in Tempus Blood collection kit)

When can I expect results?

  • xT results will be available in the Tempus clinical portal approximately 10-14 days after sample receipt.
  • If PD-L1 is ordered, results will be available in approximately 2-3 days if successful.
  • Tempus will send an email notification alerting of the sample failure and subsequent reflex to xF. From the time the xT test is reflexed to xF, results will be available in approximately 7-10 days if successful.
  • 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.

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

Any patient meeting the eligibility criteria can enroll in the program regardless of his or her insurance coverage.

How do I order forms and/or supplies?

  • Download our requisition form
  • To order kits, please contact your local sales representative, email support@tempus.com, order online through our Tempus portal or call 800.739.4137 option 1.

Where do I send the test requisition form?

Submit the requisition form and any accompanying documents inside the kit or via email to support@tempus.com or fax 800-893-0276

What if I receive a bill in error?

Tempus will not bill for the testing conducted under this program. Please email support@tempus.com or call 800.739.4137 option 1 if a bill was received in error

Can Tempus obtain the tissue for testing?

Yes, Tempus can procure the sample block from the designated pathology laboratory indicated in the completed test request form.

What is the + normal match?

The inclusion of a matched-normal specimen is known to improve the accuracy of reporting the somatic tumor variants. This method uses the patient’s own DNA rather than a reference genome to normalize the tumor DNA and identify somatic variants. Additionally, by sending in the matched-normal as a blood sample in a Streck tube, automatic conversion to xF Liquid Biopsy is available in the unlikely event that the tissue sample has failed.

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

  • This Lilly sponsored testing program covers the Tempus xT test or a Tempus xF reflex test if there the tumor specimen sequencing fails
  • By default, an unsuccessful xT test will lead to one additional tissue request before converting to xF liquid biopsy. The physician may instead choose to convert to xF liquid biopsy immediately on the requisition form instead of waiting for an additional tissue request if desired.

What if I have questions or issues?

Contact your local Tempus sales representative, email support@tempus.com, or call 800.739.4137, option 1.

This is data-driven precision medicine

This is the future of healthcare.

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