TargetNow - Caris Life Sciences

I called Caris today and spoke with one of their reps, Jessica Richards, who provided answers to Brian’s questions…and some additional information, both below and attached:
  1. Sounds like there is no problem with a single biopsy, but we should double check that with Caris. 
    • Single biopsy should be fine.  May want to send two samples from the same biopsy.
  2. We were also wondering if it mattered how the sample was preserved (frozen vs. paraffin).
    • Fresh Frozen within 30 minutes…shipped on dry ice.  Caris can provide kits for shipping and dry ice if needed.
    • Would also recommend sending a paraffin embedded sample as well. 
    • Both samples (frozen & paraffin) can be from the same biopsy.
  3. What size does the sample need to be (i.e. how much material is required)?
    • Information will be sent to the surgeon who will be doing the biopsy…see details below
Other info:

Needs from the oncologist:

·         pathologist  report

·         Requisition form.

·         Can fax all information: 866-479-4925

·         Once info is faxed from oncologist, they would work to provide the kit, dry ice, etc.

 

 

What are the specifications for sample preparation?

Submit the following patient materials for Target Now Complete:

§  Recent pathology and/or cytology report corresponding to the samples submitted to confirm a malignant neoplasm

§  Patient notes, clinical history (including prior therapy), as well as any other information deemed relevant for the patient’s continued care are helpful but not required



Tissue requirements:

§  Standard analysis (FFPE for IHC) requirements:
One paraffin block or 30 unstained slides. Core biopsies must have some tumor present in the deeper sections of the paraffin block used for the IHC testing. Blocks will always be returned in a timely fashion as requested.

§  Full analysis (fresh frozen tissue for additional DNA microarray analysis) requirements: Samples must contain 20% tumor, and consist of 0.25 grams of fresh frozen tissue, or two to three (2-3) 18-gauge frozen needle core biopsies. Place fresh tissue into vial and freeze within 30 minutes of surgery.

 
Additional info:
 
 
 
 
 
 
 
Patient Frequently Asked Questions

What is Target Now Complete?

Scientific discoveries and technological breakthroughs have made it possible to look at cancer in great detail. Target Now Complete utilizes advanced molecular profiling to provide a detailed molecular ‘blueprint’ of your tumor to your physician. Through advanced DNA, RNA and protein analysis, Target Now Complete typically identifies multiple unique genes, gene expressions and proteins in your tumor. Additionally, Target Now Complete provides information on associated drugs (to which you may or may not respond) based on research publications, clinical studies, and your tumor's unique profile. It is up to your physician to determine your appropriate treatment.

What are the benefits of Target Now Complete testing?

Target Now Complete testing provides information that may help your physician when considering potential treatment options. These therapeutic options may be directed at one or more of the identified genes and protein ‘targets’ or ‘markers’ that were identified by Target Now Complete.

How do I know if Target Now Complete testing is right for me?

Target Now Complete can be performed on any solid cancer. Target Now Complete may be most useful for cancer patients when standard-of-care treatments are ineffective, exhausted, or are not available. Even if you have already received treatment for your cancer, you can still have the test performed. However, your doctor should decide when to order the test.

What type of testing does Target Now Complete provide?

Target Now Complete testing may include immunohistochemistry (IHC). IHC detects specific proteins (part of the cancer’s infrastructure) unique to a patient’s tumor cells. DNA microarray analysis may also be used. A microarray analysis looks at which genes (DNA) are working (or not working) in the unique cancer being analyzed. In some cases, Target Now Complete testing may also include fluorescent in-situ hybridization (FISH) and gene sequencing.

How are Target Now Complete results reported?

These tests are summarized and integrated into a single report to help create a detailed molecular ‘blueprint’ of your tumor for your physicians. The report provides information and related evidence for use by your treating physicians that, along with their clinical judgment, may help them with your treatment plan. Results are sent directly to your physician.

Is Target Now Complete a diagnostic test?

No, a ‘diagnostic’ test determines whether someone may have a particular disease or medical condition. Target Now Complete testing is typically performed once your doctor has already confirmed or diagnosed that you have some form of cancer.

Is Target Now Complete the same as other tests that can tell whether my cancer could progress or if my family could have the same cancer?

No, these are called ‘prognostic’ tests. Prognostic tests help your doctor determine if you or a family member are at risk for developing a particular condition or cancer, or if there is a risk that there could be a recurrence or aggressive form of a disease or cancer. For example, the test that detects a woman’s risk of developing breast or ovarian cancer by looking at changes in two genes (the BRCA1 and BRCA2 genes) is one of these tests. Rather, Target Now Complete testing provides additional molecular information to potentially assist your doctor in the management of your cancer.

What does my doctor need from me to perform the test?

Target Now Complete is performed on tissue that is obtained during the surgical removal of your tumor (biopsy or excision). Even if your doctor doesn’t feel a need to order Target Now Complete testing at this time, the hospital where your biopsy was performed will typically store some of your tissue as standard procedure. Now or in the future, your doctor can request that Target Now Complete testing be run and coordinate with the hospital to have your sample sent to us.

Where will my testing be performed?

Target Now Complete testing is performed at the Caris MPI laboratory located in Phoenix, Arizona. Caris Life Sciences™ provides world-class oncology services nationwide to thousands of patients every week. The laboratory is CLIA certified and staffed by licensed technologists and physicians.

When will my Target Now Complete results be ready?

Once Caris receives your sample, the required forms, and medical information, testing usually takes three to seven working days. Your results will be provided directly to your physician for review and discussion with you.
 
Physician Frequently Asked Questions

What is Target Now Complete?

Through an advanced molecular profiling and clinical evidence system, Target Now Complete brings patients and their physicians information about choices to potentially optimize care by creating a molecular blueprint of a patient's individual tumor. Target Now Complete identifies clinically relevant protein and gene expression levels as well as gene sequence mutations in each patient's tumor. Each finding is then summarized in a report and accompanied by a literature-based level of evidence grading that gives a contextual understanding of its relevance. Target Now Complete biomarker analysis can help focus on therapies that could result in a response as well as those that may have a diminished or lack or response. The pace of discovery of biomarkers and their associations with therapies is moving forward rapidly. Target Now Complete is evaluating clinical literature, evolving constantly (by adding and removing tests as the literature dictates) and keeping current with the latest clinically relevant research.

How are patients selected for Target Now Complete?

Physicians may elect to choose Target Now Complete for their patients at their discretion, however, suggested guidelines are listed below:

§  Patients who have exhausted standard-of-care therapies

§  Patients with rare tumor types that have less well-defined standard-of-care treatment options

§  Patients with very aggressive cancers, where a high mortality rate exists with first line standard-of-care therapy

§  Patients who are diagnosed with cancer but have not undergone first line therapy and whose co-morbidities may preclude standard treatment options

What types of malignancies are appropriate for Target Now Complete testing?

The Target Now Complete analysis can be performed on patients with all tumors types. The Target Now Complete testing platform is both robust and flexible, allowing physicians to submit either formalin-fixed paraffin-embedded (FFPE) tissue or fresh frozen tissue samples.

What are the specifications for sample preparation?

Submit the following patient materials for Target Now Complete:

§  Recent pathology and/or cytology report corresponding to the samples submitted to confirm a malignant neoplasm

§  Patient notes, clinical history (including prior therapy), as well as any other information deemed relevant for the patient’s continued care are helpful but not required

Tissue requirements:

§  Standard analysis (FFPE for IHC) requirements:
One paraffin block or 30 unstained slides. Core biopsies must have some tumor present in the deeper sections of the paraffin block used for the IHC testing. Blocks will always be returned in a timely fashion as requested.

§  Full analysis (fresh frozen tissue for additional DNA microarray analysis) requirements: Samples must contain 20% tumor, and consist of 0.25 grams of fresh frozen tissue, or two to three (2-3) 18-gauge frozen needle core biopsies. Place fresh tissue into vial and freeze within 30 minutes of surgery.

What evidence supports Target Now Complete testing?

The scientific staff at Caris Life Sciences™ has more than three decades of experience in the field of molecular biologics and genomic study. The body of substantive research and literature continues to grow rapidly, furthering the evidence that supports the link between molecular biomarker targets and therapeutic agents for various cancers. These data are the basis of the Target Now Complete testing protocol. Target Now Complete outcomes investigations follow rigorous methods of evaluation by an independent medical evaluation team, using the U.S. Preventive Services Task Force recommended review process. Additional information on this outcomes evidence and literature review can be provided upon request. Feedback is encouraged regarding experiences with the latest targeted therapeutics and the literature. These communications are an essential aspect of creating information sharing between clinical practice applications and future developments of Target Now Complete.

How are results reported?

The Target Now Complete report provides results in an easy to interpret format. The first page provides a summary of all of the key biomarkers that may be relevant to patient care. The therapies to be considered or perhaps avoided based upon the biomarker results are also listed in this summary. Both standard of care and non-approved therapies associated with response or lack of response with these biomarkers are also listed in this summary. Subsequent pages provide more in-depth analysis of the actual protein and gene expression levels of every biomarker analyzed. Finally, the report describes the levels of evidence associated with each marker and the logic between the marker expression and the therapeutic indication. In most cases, one or more potential treatment options are identified.

How is Target Now Complete ordered?

Please call Caris at 800.901.5177 to learn more about ordering Target Now Complete. The call will be answered by a client services representative who can assist with all aspects of Target Now Complete, including requisitions, shipping and sample requirements.

Is Target Now Complete reimbursed?

The Target Now Complete is typically reimbursed by Medicare and other third party payers. Other than co-payments or deductibles required by the patient's plan, there are normally no out-of-pocket costs for the patient.

Need additional information?

To speak to a Target Now Complete representative, or request more details, please call 800.901.5177.

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