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ONCOLOGY PARTNERSHIPS

Lilly Sponsored Testing Programs

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

Lilly Lung Cancer NGS

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. Studies suggest that up to 1 out of 2 patients with mNSCLC may have an actionable biomarker.1,2,3 Only ~50% of untreated metastatic NSCLC patients in community practices are consistently being tested for all five common biomarkers ALK, BRAF, EGFR, PD-L1, and ROS1.4

There is no obligation to recommend, purchase, order, prescribe, promote or use 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. Content adapted from: Classifying lung cancer by biomarkers | LUNGevity Foundation. https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer
  2. Chakravarty D et al. J Clin Oncol. 2022;40(11):1231- 1258
  3. Hirsch, F., et al. (2017). Lung cancer: current therapies and new targeted treatments. Lancet, 389(10066):299-311
  4. 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 Solid Tumor + Normal Match DNA sequencing, xR Whole Transcriptome RNA sequencing, xF Liquid Biopsy auto-conversion, or PD-L1 testing offered through this program (xR is not offered in NYS). 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 are available in the program?

xT Solid Tumor + Normal Test
If a normal sample is not received, xT Tumor Only test will be run.

  • xT Solid Tumor/Normal Match is a 648-gene DNA panel sequenced at an average of 500x depth of coverage on FFPE tumor tissue and 150x on paired normal (blood or saliva) specimens. It includes reporting of incidental germline alterations in 65 genes when detected, as well as assessment of TMB and MSI status.

xR Whole Transcriptome RNA Test

  • xR is a whole transcriptome RNA panel sequenced with an average of 50 million unique reads on FFPE tumor tissue.

xF Liquid Biopsy Test
Will only be used as an auto-conversion test when tumor specimen cannot be successfully sequenced and a normal sample has been submitted.

  • xF is a 105-gene ctDNA panel sequenced at average 20,000x depth of coverage (at least 5,000x unique reads), with assessment of SNVs, CNVs, and chromosomal rearrangements in a subset of genes. MSI-High status is reported when detected.

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

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

Note: The Lung Cancer NGS 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:

  1. Download the Lung Cancer NGS Program test requisition form or the NYS specific 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 10-21 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 + xR results are typically expected to be available in the Tempus clinical portal approximately 10-21 days after specimen receipt.
  • If PD-L1 is ordered, results will be available in approximately 2-3 days if successful.
  • If tissue is insufficient for molecular sequencing, Tempus will send an email notification alerting you of the sample failure and subsequent auto-conversion to xF Liquid Biopsy Test. xF results will be available approximately 7-10 days if successful following alert of tissue insufficiency.
  • 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?

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 auto-conversion to Tempus xF Liquid Biopsy test if the tumor specimen sequencing fails.
  • By default, an unsuccessful xT + xR 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.

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Lilly Thyroid Cancer NGS

Lilly is sponsoring Tempus sequencing to offer comprehensive genomic profiling for eligible patients who have advanced or metastatic medullary thyroid cancer (MTC) OR advanced or metastatic non-medullary thyroid cancer (non-MTC). Through this program, eligible patients will be able to receive next-generation sequencing (NGS) at no cost. 

There is no obligation to recommend, purchase, order, prescribe, promote or use 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.

View Frequently Asked Questions

What is the Thyroid Cancer NGS Program?

The Thyroid Cancer NGS Program is a Lilly sponsored program that offers comprehensive genomic profiling at no cost for eligible and appropriate thyroid cancer patients. Lilly will cover the cost of the test regardless of the test results and treatment decision.

Will there be any cost to the patient?

No. No eligible patient, nor their clinicians or beneficiaries, will be billed for the xT Solid Tumor + Normal Match DNA sequencing, xR Whole Transcriptome RNA sequencing, or xF Liquid Biopsy auto-conversion (xR is not offered in NYS). Tempus will not bill the patient or the patient’s insurance for the test.

What patients are eligible?

Patients who meet all of the following criteria: 

  • Patients who have advanced or metastatic medullary thyroid cancer (MTC) OR advanced or metastatic non-medullary thyroid cancer (non-MTC)
  • Patients that live and receive treatment in the United States or a US Territory (including Puerto Rico, Guam, and the Marshall Islands)
  • Patients who do not have a known molecular biomarker identified by prior testing 
  • Patients who have not had prior comprehensive biomarker testing
  • Patients who have not been previously tested under this Program

Healthcare professionals and patients who participate in this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use or support any other products or services from Tempus, Lilly, or any other third parties or commercial organizations. 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, Tempus, or any other third parties or commercial organizations.

What Tempus Tests are available in the Thyroid Cancer NGS Program?

xT Solid Tumor + Normal Test
If a normal sample is not received, xT Tumor Only test will be run.  

  • xT Solid Tumor/Normal Match is a 648-gene DNA panel sequenced at an average of 500x depth of coverage on FFPE tumor tissue and 150x on paired normal (blood or saliva) specimens. It includes reporting of incidental germline alterations in 65 genes when detected, as well as assessment of TMB and MSI status. 

xR Whole Transcriptome RNA Test

  • xR is a whole transcriptome RNA panel sequenced with an average of 50 million unique reads on FFPE tumor tissue.

xF Liquid Biopsy Test
Will only be used as an auto-conversion test when tumor specimen cannot be successfully sequenced and a normal sample has been submitted.

  • xF is a 105-gene ctDNA panel sequenced at average 20,000x depth of coverage (at least 5,000x unique reads), with assessment of SNVs, CNVs, and chromosomal rearrangements in a subset of genes. MSI-High status is reported when detected.

Note: The Thyroid Cancer NGS 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:

  1. Download the Thyroid Cancer NGS Program test requisition form or the NYS specific 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 and select ‘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, via email to support@tempus.com, or by fax to 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 10-21 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

Normal Sample + xF Liquid Biopsy Requirements:

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

*Tempus will accept samples of any age. Please note that samples older than 5 years of age are more likely to fail. If a recent sample is not available and liquid biopsy is preferable, please contact support@tempus.com to indicate that the order should be converted to xF.

What can patients do if they don't have access to travel for a blood test?

Patients who are unable to travel to a medical facility for a blood test can benefit from Tempus’ mobile phlebotomy services. This service allows patients to schedule a blood draw appointment at a location that is convenient to them. To schedule an appointment for mobile phlebotomy services, patients can call 800.739.4137.

When can I expect results?

xT + xR results are typically expected to be available in the Tempus clinical portal approximately 10-21 days after specimen receipt. 

If tissue is insufficient for molecular sequencing, Tempus will send an email notification alerting you of the sample failure and subsequent auto-conversion to xF Liquid Biopsy Test. xF results will be available approximately 7-10 days if successful following alert of tissue insufficiency.

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 Patient/Provider data will be shared between Tempus and Lilly?

Ordering provider identifying information may be shared with Lilly. Tempus will not share protected health information with Lilly as part of this program.

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, Tempus, or any other third parties or commercial organizations.

What type of insurance does my patient need to participate in the Thyroid Cancer NGS Program?

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

How do I order test requisitions and/or supplies?

Download the Thyroid Cancer NGS Program test requisition form or the NYS specific 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 and select “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 to 800.893.0276.

What if I receive a bill in error?

Tempus will not bill for the testing conducted under the Thyroid Cancer NGS Program. Please email support@tempus.com or call 800.739.4137 and select ‘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 solid tumor + normal match?

Solid tumor + normal match testing uses the patient’s own DNA rather than a reference genome to normalize the tumor DNA findings and can distinguish between somatic and germline variants  This method of testing  is known to improve the accuracy of reporting somatic tumor variants: a recent study found that addition of a normal match resulted in 28% reduction of somatic false-positive calls, improving accuracy compared to tumor-only analysis.1 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 event that the tissue sample has failed.

 

1. Beaubier N, Bontrager M, Huether R, et al. Integrated genomic profiling expands clinical options for patients with cancer. Nat Biotechnol. 2019;37(11):1351-1360.

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

This Lilly sponsored testing program covers the auto-conversion to Tempus xF Liquid Biopsy test if the tumor specimen sequencing fails.

By default, an unsuccessful xT + xR 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.

If it is determined that an appropriate specimen is not available, please contact support@tempus.com to request that the order be converted to xF.

What if I have questions or issues?

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

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