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# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
1

Electronic interface to get the diagnostic data into our data warehouse.

They have an interface that can get the reports into OncoEMR. They have also represented they can share results and data easily with EMOL.

Partnering with Flatiron with mid-2020 scheduled release.

We currently utilize the Xifin LIS System and have the ability to establish electronic interfaces. Currently working on establishing an interface with EPIC.

They have an interface that can get the reports into OncoEMR. They have also represented they can share results and data easily with EMOL.

Yes.

Yes. Can provide data transfers of raw molecular data directly to data warehouse.

3 Types: (1) electronic ordering interface to integrate testing in to existing workflows. (2) a return of Tempus test results directly into EMR (pdf). (3) Secure data exchange to abstract & clean EMR data that powers downstream applications for research, analytics & trial matching.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
2

If data is sold, is there a rev share opportunity?

No mention of data sales.

2.5% of total revenue. They believe initially that this is at least an annual $40M total opportunity meaning that NCCA will get $1M. The $1M is guaranteed in the first year.

Yes.

They do not sell data.

Yes.

Yes. No specifics provided.

15% of revenue.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
3

Are you in network for all payers? What is the prior authorization process and who does it? If the insurer denies, is the patient or the practice billed for the test?

Covered by most payers, including CMS. Approx 225K covered lives. Can handle prior auth process if required. Will assist with all appeals. “If the claim is denied in full due to no-authorization with $0 set to the allowed amounts, Caris will not bill the patient.”

Foundation Medicine is in-network with some commercial health plans including Cigna and some Blue Cross and Blue Shield plans. While all commercial health plan coverage is pursuant to the applicable health plan’s medical policy and specific patient benefit levels, FMI will follow our current billing practices, which includes billing the health plan for the test and appealing claim denials with the patient’s consent, regardless of FMI’s network status with the health plan.

No. Our tests are approved and paid by Medicare. We bill out of network for commercial payers and currently receive payment upon medical necessity. We do not require prior authorization to perform testing. Currently, we are billing commercial insurance without prior authorization unless prior auth is gained at the physician office/practices. We will work with each practice when prior auth is needed and are open to building a support process if needed. If insurance denies, the patient is not billed for testing.

Lab is in-network, contracted with 98% of payers nationally. For insurances that allow lab to complete prior auth, they complete prior auth services for most large panel testing.

In network with most national and regional payers. Clinician is responsible for prior authorization.

Yes. All national and many local with over 200M lives covered.

In network with Aetna, Priority Health, Avera and Medicare. Tempus performs all prior auths except for California IPAs and HMOs.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
4

Describe your resources for obtaining patient assistance.

Describe your resources for obtaining patient assistance.

Patients can apply for financial assistance at any time during the testing process. Patients who apply for financial assistance may be approved for 0% to 100% of their final balance due. A financial assistance application is available online https://aid.foundationmedicine.com

We offer a Payment Plan and Financial Assistance Program that provides financial flexibility and assistance for patient needs.

Oncology Patient Assistance Programs for large panels. Certain tests of have LabCorp billing team that works with the patient.

Will match whatever sliding scale the practice if honoring.

Dedicated billing team focused only on oncology. Offer assistance up to 400% of federal guidelines.

Needs-based. Decision on approval is made at time of submission of application.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
5

How many actionable, targeted immune-therapy genes do you provide tests for? Reflex to liquid biopsies? Do you dissect out the tumor cells from specimens? RNA as well as DNA? Proteomics? Germ line mutations?

592 genes (DNA) and 22,000 genes (RNA), Up to 15 clinically relevant IHCs (optimized across 25 tumor types).

406 (DNA) and 265 (RNA).

177 actionable/targeted genes – DNA only.

525 genes for targeted therapy and 67 for immunotherapy.

We do PD-L1 IHC for all the FDA-approved CDx (complete library of all PDL1 clones covering all indications). In fact, we are probably the national leader in this. We also do MSI PCR and MSI NGS as well as MMR IHC. We also do TMB by NGS checking >320 genes (and are a member of Friends of Cancer).

2 panels: WES/WTS that has ~20,000 genes.

648-genes for targeted DNA-sequencing. 105 genes on oncogenic and resistance mutations.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
6

How many other genes do you provide tests for?

RNA provides clinically relevant information on translocations and expression of 1,385 genes with a focus on 67 specific genes associated with hematologic neoplasms. Can detect various translocations involving ABL1, RUNX1, BCL2, RARA, PAX5, JAK2, CBFB and other genes involved in leukemia, lymphoma and myeloma.

Many of our competitors do have larger panels; we are currently working on a larger panel due out later this year. Of note – there are less than 140 genes related to cancer that are “clinically actionable”, meaning they have the potential to change the management of the patient by guiding targeting therapy, qualifying the patient for clinical trials, or indicating a difference in disease prognosis. Our panels cover ALL of those genes.

“Pancancer” tests 2,100 additional genes

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
7

Perform diagnostic services for liquid biopsies?

ADAPT Biotargeting System™ enables an unbiased target profiling of complex and diverse biological systems in their natural state(s). One application of the ADAPT Biotargeting System™ is a unique exosome-based, liquid biopsy for cancer diagnosis and disease monitoring. 

Yes.

Yes – We offer liquid biopsy testing utilizing cell-free DNA (cfDNA). We have a liquid bx Hematology profile that can be performed on peripheral blood for diagnostic purposes. For solid tumors, we can perform testing utilizing a liquid bx for monitoring patients and recommend testing the tissue sample for diagnostic needs to appropriately detect mutations, increase sensitivity and perform RNA analysis.

Yes. Stand-alone liquid biosy test and can be reflex for lung cancers.

Yes.

No.

Yes. The 105-gene comprehensive liquid biopsy.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
8

What do you do to facilitate tumor boards?

Caris Molecular Tumor Board is an aon-demand platform for clinicians, pathologists and sentiests to interact with leading cancer experts. This platform facilitates collaboration and expert review & interpretation.

As a pioneer of the molecular tumor board Foundation Medicine organizes and then curates’ content to facilitate rich dialogue, powered by robust core data set with institutions on HIPAA-compliant molecular tumor boards. Institutions suggest the cadence which and be either monthly or quarterly and Foundation Medicine facilitates the tumor board.

Yes, we facilitate tumor boards through the assistances of our PhDs, Pathologist, or Educator, format is determined by the client.

We can facilitate molecular tumor boards with one of our expert pathologists, your local pathologist, and oncologist. We currently do this once a month or once a quarter for our clients who would like this value add.

They can provide the board-certified directors as a resouce. For this questions, they also mentioned their patient engagement platform.

Can provide internal Molecular Pathology, Medical Affairs and Variance Science Team members. At least 3 tempus patients need to be discussed at tumor board.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
9

Do you have a phone app?

No mention of one.

Yes.

No.

Yes. It allows patience to view their lab results or schedule blood test appointments.

No.

No.

Yes.

# CRITERIA Caris Foundation Genomic Testing Co-Operative LabCorp NeoGenomics Sema4 Tempus
10

Do you link to clinical trials?

Caris Pharmatech is the pioneer of just-in-time clinical trial solutions – rapid site activation and patient enrollment. The also have the Precision Cancer Alliance.

Foundation Medicine currently facilitates clinical trial matching through multiple resources and vehicles.

Yes, see attached sample reports. We include open clinical trials specific to the clinical findings.

Yes. Link to Covance, which they own.

Yes. They are an NCI match approved lab.

Yes. The have clinical trial matching capabilties.

Yes. Has proprietary clinical trial matching system.

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