Beyond OncoType: Test Service Approach Prospers

Beyond OncoType: Test Service Approach Prospers

In the traditional in vitro diagnostics (IVD) market, diagnostic companies (manufacturers) develop, manufacture, and market diagnostic tests that are sold to and used by clinical laboratories.  In the U.S., these tests are regulated by the FDA.  This is the model that is being followed by a large segment of the cancer diagnostics market today.  However, for cancer diagnostics, there have been exceptions to this model all along.  For example, histology laboratories purchase stains, and often purchase antibodies and/or probes that are then used for immunohistochemistry or in situ hybridization tests that are developed and validated by the clinical laboratory.

Many new cancer diagnostic tests that are being developed and offered today are highly complex assays, and it may not be easy to put the reagents for these tests into a kit for shipment to clinical laboratories.  In addition, developing a laboratory developed test (LDT) has historically been a faster route to market, although the regulatory environment for LDTs is changing.   As a result of these and other factors, many diagnostic companies have decided to commercialize their cancer tests by performing these tests in their own CLIA-certified laboratory.  An early and very successful company to offer this type of service was Genomic Health with its OncoType DX assays.  For 2014, Genomic Health reported $275.7 million in revenues, all of which was product revenue generated by performing tests in the company’s CLIA laboratory.
 Genomic Health, Inc. was founded in 2000 and is focused on development and commercialization of genomic-based clinical laboratory services to improve the quality of cancer treatment.  These services are provided by the company’s CLIA-certified laboratory.  The tests use tissue (tumor) specimens.  The company’s lead product is the Oncotype DX Breast Cancer Test, which is a 21 gene assay that provides clinical experience information for newly diagnosed patients with node-negative or node-positive, ER-positive, HER2-negative invasive breast cancer.  The result provides an individualized prediction of chemotherapy benefit and 10-year distant recurrence.  Genomic Health reports that the Oncotype DX Recurrence Score® result cannot be predicted by traditional clinicopathologic variables, and provides critical information that changes treatment decisions approximately 37% of the time.

Numerous studies have been conducted to validate these assays.  Results of these studies are discussed on the Genomic Health web site.  Genomic Health is continuing to develop new technology and new tests for the future.  In the company’s most recent Form 10-K, Genomic Health reports that the company had selected next-generation sequencing (NGS) as the company’s primary technology for future biomarker discovery and have begun using NGS for future clinical development in tandem with the company’s existing RT-PCR based approach.  Another company that has successfully followed this strategy is Myriad Genetics.  For the fiscal year ending June 30, 2014, Myriad Genetics reported $778.2 million in revenues, of which $748.2 million were molecular diagnostic testing revenues. 


Genomic Health, Myriad Genetics, and many other companies that offer proprietary tests through their own CLIA certified laboratories are profiled in Chapter 9.  Most of these other companies are private, and their revenues appear to be much less than Myriad Genetics’ or Genomic Health’s revenues today.  However, this is a rapidly growing market.  Examples of companies that are developing and/or offering cancer diagnostic tests as laboratory developed tests are shown below.  The full study is available for purchase at www.kaloramainformation.com

 

20/20 GeneSystems, Inc.

PAULA’s (Protein Assays Using Lung cancer Antigen’s) test for early detection of lung

Available as a test service

Adaptive Biotechnologies Corporation

•immunoSEQ - A proprietary suite of immune profiling assays  (available as research use only kit or test service)
•clonoSEQ - A clinical assay that measures lymphoid clonality and distribution (offered as testing service)

Available as testing service

RUO kit available as indicated

Admera Health
(A GENEWIZ Company)

•DNA sequencing and mutation analysis of EGFR and KRAS
•PGxOne™ pharmacogenomics test

•OncoGxOne™ and OncoGxOne™ Plus
•FloraCheck™
•Other non-invasive cancer tests

Available as testing service


In development

 

 

 

 

 

 

Biocept, Inc.

OncoCEE-GA™ for gastric cancer, OncoCEE-BR™ for breast cancer and OncoCEE-LU™ for non-small cell lung cancer plus test for BRAF mutations in patients with melanoma; Based on circulating tumor cells (CTCs)

Available as a testing service

Biodesix, Inc.

•VeriStrat, a blood-based proteomic test that identifies the host patient response to the tumor
•GeneStrat, a targeted liquid biopsy mutation test for patients with advanced lung cancer

Available as test service

 

 

 

bioTheranostics, Inc.

Breast Cancer IndexSM
bioT3 - Includes CancerTYPE ID, and CancerTREATMENT ID.

Available as a test service

Caris Life Sciences

• MI Profile™ - A multi-platform solid tumor biomarker analysis for therapeutic decision support and clinical trials matching.
• Next-Generation Sequencing Cancer Service
• Individual assays - For single or multiple marker analysis

Available as test service

Castle Biosciences ,Inc.

• DecisionDx-Melanoma
• DecisionDx-UM
• DecisionDx-EC
• DecisionDx-Mesothelioma
• DecisionDx-GBM

Available as test service

City of Hope Molecular Diagnostic Lab

Molecular oncology tests offered include:
•Solid tumor hotspot mutation panels: 48 gene panel (Onco48 Panel); Lung Cancer (OncoLung Panel); Melanoma (OncoMelanoma Panel); Colorectal Cancer (OncoColon Panel); All RAS panel: KRAS, NRAS, HRAS (RAS-NGS)
•Microsatellite Instability Analysis (MSI)
•MLH1 somatic promoter hypermethylation
•Prosigna™ Breast Cancer Prognostic Gene Signature Assay (PROSIGNA-BREAST)

Available as testing service

Clarient Diagnostic Services
(A GE Healthcare Company)

Wide range of assays to provide information on cancer tissues and cells.  These include IHC, flow cytometry, molecular/PCR, FISH, ISH, cytogenetic karyotyping, and microarrays. 

Available as testing service

Genomic Health, Inc.

Oncotype DX Breast Cancer Test
Oncotype DX Test for DCIS
Oncotype DX Colon Cancer Test
Oncotype DX Prostate Cancer Assay

Available as test service

Genoptix (A Novartis Company)

Full service cancer diagnostics and pathology laboratory

Tests available as testing service

Guardant Health, Inc.

Guardant360® - Digital sequencing of a 68 gene panel; includes all NCCN recommended genomic biomarkers for solid tumors

Available as a test service

 

 

 

Laboratory Corporation of America (LabCorp)

Comprehensive range of general and specialty cancer diagnostic tests.

Available as test service

MDxHealth SA
(formerly Oncomethylome Sciences)

ConfirmMDx for Prostate Cancer

Available as test service

MedGenome Labs Private Ltd. (India)

Genomics-based diagnostics and research company; Genetic tests and molecular diagnostics solutions for precision medicine and patient management; range of Sanger sequencing, NGS, and PCR-based tests for oncology

 

Myriad Genetics, Inc.
Myriad RBM, Inc.

• Myriad myRisk™ Hereditary Cancer
• BRACAnalysis®
• COLARIS®
• COLARIS AP®
• MELARIS®
• PANEXIA®

• BRACAnalysis CDx
• Myriad myPlan® Lung Cancer
• Myriad myPath™ Melanoma
• Prolaris®

myChoice HRD companion diagnostic test

Available as a test service





Available as a test service



In development

Novigenix

Colox®, a molecular blood test for the detection of colorectal cancer and pre-cancerous lesions (adenomatous polyps); gene expression profile of 29 biomarkers by real-time PCR in PBMCs

Available as laboratory developed test and as CE registered kit

Pathway Genomics Corporation

BreastTrueTM High Risk Panel, BRCATrueTM, BRCATrueTM Ashkenazi Jewish (3-Site), and BRCATrueTM Hispanic Jewish (3-Site).  In addition, Pathway Genomics now offers ColoTru™ (analysis of 14 high-risk colorectal cancer genes) and LynchSyndromeTrue™ (analysis of five genes associated with Lynch syndrome).

Available as test service

Quest Diagnostics Inc.

Comprehensive range of general and specialty cancer diagnostic tests.

Available as test service

Resolution Bioscience

ALK assay
Resolution Bio ctDx™ Lung assay

Available as test service

Response Genetics, Inc.

•ResponseDX: Tissue of Origin Test
•ResponseDX:  Next Generation Sequencing Panels (NSCLC Next Generation Sequencing Panel, the Solid Tumor Genotyping Panel, and the AML/MDS Next Gen Sequencing Leukemia Panel)
•ResponseDX Biomarker Tests

Available as test service

TrovaGene, Inc.

• PCM BRAF V600E Mutation Detection Test
• PCM KRAS Mutation Detection Test
• PCM EGFR Mutation Detection Test
• HPV HR Detection Test

Available as test service

Veracyte, Inc

•Afirma Thyroid FNA Analysis, includes Affirma Gene Expression Classifier
•Percepta™ Bronchial Genomic Classifier

Available as test service