- Personalized Medicine – Cancer DNA profiling -

Star Health Network offers personalized medicine using advanced diagnostic technologies to its network partner hospitals.
Star is currently offering Cancer detection tests developed by the leading medical institutions in the United States which are backed by their world-class pathologists, oncologists & scientists. Star delivers cutting-edge testing, accurate diagnosis, and expert consultation, based on the most current discovery – on every case received.

• Targeted Tumor Profiling: provides the most cutting edge tumor genotyping technology clinically available today. The panels are tailored specifically to each tumor, resulting in a uniquely focused and targeted diagnosis. The report provides immediate insight into the nature of the mutation and delivers a strong basis for identifying the personalized treatment plan for each patient. Each patient’s report presents ONLY clinically relevant information, focusing solely on 69 actionable mutations. Actionable means there is a treatment available for the type of mutation detected.

Relevant tumors tested include:

• Breast
• Lung
• Ovarian
• Acute Leukemia
• Biliary Tract
• Colorectal
• Thyroid
• Melanoma Pancreas
• Urinary Tract

• Next-Generation Cancer DNA Sequencing: uses advanced new technologies that conduct large scale genomic tumor assessment that reveal hundreds of cancer related DNA alterations/mutations that may be driving the growth of a cancer and can help identify treatment options that may be available to patients based on the alterations unique to their cancer. Next generation sequencing is more comprehensive and identifies more potential treatment options than other available tests because it analyzes all genes known to be relevant in human cancers.

Star Health Network’s partner institutions in Cancer Personalized Medicine:

• Precipio Diagnostics - Yale School of Medicine
• Thomas Jefferson University Hospital - Kimmel Cancer Center
• Fox Chase Cancer Center

Q&A

• SCIENCE

• TESTING

• REPORTING

• LOGISTICS

• BILLING

SCIENCE
What is tumor profiling?

Tumor Profiling provides a genetic mutational analysis of a tumor. The purpose of this analysis is to identify available targeted treatments that are specifically designed for your tumor type and situation.

In the past, there were few treatment options available for physicians to treat their patients, and so most patients received the same general treatment. As science developed and the understanding of the biology of cancer deepened, researchers realized that cancer is driven by gene mutations, and it is those genetic mutations which must be identified and targeted with focused therapies, rather than a general treatment. Drug companies continue to develop targeted therapies, which directly focus on specific mutations. The analysis of a patient’s tumor for specific mutations, and the subsequent adaptation of focused therapies to that patient’s situation, is called personalized medicine.

There are a constantly growing number of newly developed drugs that target specific mutant proteins within malignant (cancer) cells, or that target critical biochemical pathways that have been altered within malignant cells as a result of mutations acquired within a tumor. These mutant proteins cause the cancer to proliferate; targeted therapies are designed to stop those mutants in their tracks, helping patients in the battle with cancer. Understanding the genetic fingerprint of a tumor can help your oncologist choose therapies while avoiding other medications, providing better, more focused treatment to you.

A tumor profiling test will identify the mutations present in your tumor genetic composition, and report the treatment options that are associated with clinical benefit (targeted therapies) or lack of clinical benefit (tumor resistant therapies). The report will provide your oncologists with detailed mutational profiles of your tumor so that treatment may be individually optimized through personalized medicine.

Some gene mutations may indicate that a tumor is resistant to drug treatment. This means that the oncologist may elect an alternative treatment, rather than putting the patient through the pain, suffering and cost of chemotherapy, which is unlikely to have a positive effect. Understanding the genetic fingerprint of a tumor can help your oncologist choose therapies while avoiding other medications.

The tumor profile test is performed at Star’s partner U.S. institutions. It is directed and operated by some of the leading scientists and researchers in Academia worldwide. Backed by the highest level of science and research conducted at these institutions, tumor profiling is constantly being updated with the latest developments in personalized medicine, to ensure that all options are available to the clinician. Physicians and scientists rely on the tests conducted at the tumor-profiling lab for their patients.

Tumor profiling is relevant to any cancer patient with one of the tumors listed in the Types of Cancer section.

The tumor-profiling lab was set up and designed specifically to deal with the challenge of small biopsies and minimal tissue remaining for testing. The technology deployed in the testing, as well as various processes and techniques deployed for each tumor, ensure that we are able to test and generate results out of the smallest amount of tissue, which are often rejected by other labs. We routinely receive biopsies that were sent initially to other labs, which failed to run the test due to inadequate amount of tissue, and we are successful at completing the testing and generating results for the patient.

You can feel confident knowing that a negative test result means there are no actionable gene mutations present in your tumor. Academic labs perform comprehensive testing on each gene for relevant mutations. They have and continue to be on the cutting edge of science, and adapt the latest discoveries of gene mutations and subsequent therapies into the testing panel.

Yes, it can. Physicians will often put patients on initial treatment immediately to begin treating the cancer. Meanwhile, tumor profiling can be conducted to determine additional options of personalized medicine available to the patient in the future.

Yes, tumor profiling does not require fresh tissue; it can be done on biopsies that were done years ago, as the genetic fingerprint of that tumor has not changed.

My tumor has metastasized to a different part of my body.

Since tumor profiling tests for mutations on a genetic level, the genetic information is carried throughout your tumor, regardless of its origin or metastatic location. Therefore, the test can be conducted on any biopsy location, as long as it contains malignant cells.

REPORTING
Do your provide information about clinical trials?

When a mutation is found to be positive, a clinical trial review will be performed in your geographical area to identify clinical trials that may be relevant to your situation. You and your physician can decide if this option is right for you. You will need to consult with your oncologist regarding your clinical history, tumor profiling and treatment options.

Clinical trials publish their criteria for patients to qualify for their trails. We encourage you to seek the advice of your physician, as well as a genetic counselor to assist you in evaluating this option. Furthermore, clinical trial administrators will help evaluate your situation to ensure you meet the proper criteria.

The tumor profiling labs test for all actionable mutations that may help your physician select the appropriate therapy. Mutations may exist for which there are no actionable relevance – these mutations are not tested because they ultimately will not provide your physician with any information that will help select the right treatment, and therefore there is no clinical benefit to incurring the costs of testing for those mutations. When no mutations are found, there is still valuable information to a treating oncologist to rule out certain treatment options. This information will help the oncologist begin the appropriate treatment plan in a timely manner.

For each case, for every patient, Star will facilitate a consultation discussion for your oncologist with an expert, who can review your report and your specific situation. Many of the oncologists we work with benefit from an in-depth discussion with an expert, who can provide unparalleled experience and expertise, to help understand the information, which can guide your treatment.

LOGISTICS

You will have to visit the designated Star Health Network partner hospital. An oncologist at our partner hospital will complete a requisition form in order to request the test on your behalf.

Once the requisition is received Star Health Network partner hospitals will help you:

1. Make a Payment
1. By credit card at www.starhealthnetwork.com, or
2. Will facilitate your payment to our local banking institution.
2. Dispatch your biopsy to Star Health Network partner institution in India. They will usually package up the biopsy and relevant paperwork, and overnight it to the United States by courier.
3. Upon receipt of the payment and biopsy, testing will begin right away.

Our turnaround time (TAT) is 10 business days once we receive the biopsy from the pathology group. You should expect your physician to have the results in approximately 2 weeks.

The final report will be sent to your physician by email or fax, and uploaded to our web-based portal. Once your physician has received the report, your physician can share the report with you. Your physician can then discuss the test results and treatment options that are available to you. If you have not received results in a timely manner (3 weeks), you can always reach out to your physician to check the status on your results.

Star Health Network and all its partner hospitals follow strict U.S. HIPAA guidelines to ensure the security of your information. All personal information and results are protected and shared only with your ordering physician.

BILLING
Will my insurance company cover the costs of this test?

Some insurance providers cover the testing performed at U.S. Tumor Profiling labs. You can ask your provider for your specific individual policy referring to the insurance coverage.

Yes it does. The cost of the test is based on the number of genes tested, and that varies by cancer type. The laboratory will review all information received, and determine the relevant genes to be tested. Therefore, the panel is customized to best suit the type of cancer tested.

The tumor-profile test done at a U.S. institution has several advantages that make it extremely cost efficient:
a. The panel is customized to each tumor type. This means that, unlike other labs that test an entire group of the same genes per each tumor type, we test only for those genes relevant to the type of tumor. This reduces the costs of unnecessary testing.
b. The test is done in a stage & reflex manner. This means that we begin by testing the most prevalent genes for that cancer type, seeking mutations. If we find a mutation, and it is one that precludes having additional gene mutations, we will complete the test without continuing to test unnecessarily for other genes. This too reduces the costs of unnecessary testing.

This is a complicated debate in which both sides of the argument hold some truth. Molecular testing is indeed expensive (although costs are dropping all the time), and there are many approaches to molecular testing where tests are set up to cover a large number of genes which are often irrelevant to that tumor type. However, the value of the information that may be gathered in molecular testing is extremely valuable as well. Since the purpose of molecular testing is to identify whether the patient tumor may be responsive or resistant to certain chemotherapies (which are extremely expensive), reaching the right treatment decision, which is backed by information gathered from molecular testing, can save substantial costs. More importantly, it can save the patient significant pain and suffering that may occur of the therapy wasn’t correctly tailored to the patient situation.

The test cost varies based on the number of genes tested. This is determined by two factors:
a. The patient specific information, including the type of cancer, will determine which genes will be tested.
b. The results of the initial stages of testing may determine how many of those genes are actually tested.

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