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May 13, 2013

Companion Diagnostics: 52 Pick-Up

Check out our three lists of 52 CDx: those approved by the FDA, those under review right now, and those that may be coming soon.

Companion Diagnostics: 52 Pick-Up

Here is a rundown of all 15 FDA-approved companion diagnostics, a pair of CDx submissions for FDA review, and 35 recent announcements of CDx collaborations between developers of diagnostics and drugs. [© adimas - Fotolia.com]

  • Following are three lists depicting recent activity in the development of companion diagnostics: a rundown of all 15 FDA-approved companion diagnostics, as listed on the “Companion Diagnostics” page of the agency’s website, last updated April 17 and accessed May 3; a pair of submissions submitted in recent months for FDA review; and 35 of the most recent announcements of companion diagnostic collaborations between developers of diagnostics and drugs. The announcements appear on the companies’ websites, and/or were reported by GEN and other news outlets between August 2011 and this month. Not included were announcements of diagnostics agreements that merely specified they would be used in “research,” without a mention of current or future drugs they would accompany.

    In many cases, the announcements do not specify a specific drug for the diagnostic, but state that the diagnostic is intended for use with several drugs. Some announcements did not cite the specific technology being applied in the trumpeted companion diagnostic. And nearly all announcements omitted financial terms, though there were a few exceptions.

    Not surprisingly, diagnostics developers have been active in signing agreements with several drug companies for companion assays; Qiagen has said publicly it has 15 such projects in the works. The August 2011 cutoff omits details of numerous earlier deals by other diagnostics providers with drug companies; in addition to the deals listed below, for example, Agilent Technologies (which acquired Danish-owned Dako last year) has earlier collaboration agreements with AstraZeneca, Quintiles, and Roche. On the diagnostics side, Roche inked earlier deals with Merck, Clovis Oncology, and Transgene.

    Approved companion diagnostics are listed by name, sponsor-developer, and a summary of the official intended use/indications for use (IU/IFU) as listed by FDA. Companion diagnostics submitted recently for review or in the works are listed by sponsor-developer, date of submission or announcement, summary of what the diagnostic is supposed to do, and financial details, if disclosed.

  • FDA-Approved CDx

    Inform Her2/Neu
    Sponsor/Developer: Roche (Ventana Medical Systems)
    Intended Use/Indications for Use: Fluorescence in situ hybridization (FISH) DNA probe assay determines the qualitative presence of Her2/Neu gene amplification on formalin-fixed, paraffin embedded human breast tissue. Stratifies breast cancer patients who have had a priori invasive, localized breast carcinoma and who are lymph node-negative, according to risk for recurrence or disease-related death.

    PathVysion Her2 DNA Probe Kit
    Sponsor/Developer: Abbott (Abbott Molecular)
    Intended Use/Indications for Use: Detects amplification of the Her2/neu gene via FISH in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Predicts disease-free and overall survival in patients with stage II, node-positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. Assesses patients for whom herceptin (trastuzumab) treatment is being considered.

    Pathway ANTI-Her2/NEU (4B5)
    Sponsor/Developer: Roche (Ventana Medical Systems)
    Intended Use/Indications for Use: Mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB-2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide-staining device. Assists in assessment of breast cancer patients for whom Herceptin treatment is being considered.

    DAKO EGFR PharmDx Kit
    Sponsor/Developer: Agilent Technologies (Dako)
    Intended Use/Indications for Use: Qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplastic tissues routinely fixed for histological evaluation EGFR pharmDx specifically detects the EGFR (Her1) protein in EGFR-expressing cells. Assists in identifying colorectal cancer patients eligible for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).

    DAKO C-KIT PharmDx
    Sponsor/Developer: Agilent Technologies (Dako)
    Intended Use/Indications for Use: Qualitative IHC kit system used on the Dako Autostainer for the identification of c-kit protein/CD 117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit pharmDX rabbit polyclonal antibodies specifically detect the c-kit protein in CD 117 antigen-expressing cells. Assists in differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit pharmDx may be used as an aid in identifying those patients eligible for treatment with Gleevec/Glivec (imatinib mesylate).

    InSite Her2/NEU Kit
    Sponsor/Developer: Biogenex Laboratories
    Intended Use/Indications for Use: For use in IHC assays to semi-quantitatively localize by light microscopy the overexpression of Her2/neu (i.e., c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue sections. Assists in the assessment of breast cancer patients for whom Herceptin (trastuzumab) therapy is being considered.

    SPOT-Light Her2 CISH Kit
    Sponsor/Developer: Life Technologies (being acquired by Thermo Fisher Scientific for $15.8 billion)
    Intended Use/Indications for Use: Intended to quantitatively determine Her2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections using chromogenic in situ hybridization (CISH) and brightfield microscopy. Assists in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    Bond Oracle Her2 IHC System
    Sponsor/Developer: Leica Biosystems
    Intended Use/Indications for Use: Semi-quantitative IHC assay to determine Her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. Assists in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    Her2 CISH PharmDx Kit
    Sponsor/Developer: Agilent Technologies (Dako)
    Intended Use/Indications for Use: Intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the Her2 gene and centromeric region of chromosome 17. Designed to quantitatively determine Her2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Assists in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    INFORM Her2 DUAL ISH DNA Probe Cocktail
    Sponsor/Developer: Roche (Ventana Medical Systems)
    Intended Use/Indications for Use: Intended for determining Her2 gene status by enumeration of the ratio of the Her2 gene to Chromosome 17. The Her2 and Chromosome 17 probes are detected using two-color CISH in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark XT automated slide stainers (using NexES software), by light microscopy. Assists in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    VYSIS ALK Break Apart FISH Probe Kit
    Sponsor/Developer: Abbott (Abbott Molecular)
    Intended Use/Indications for Use: Qualitative test to detect rearrangements involving the anaplastic lymphoma receptor tyrosine kinase (ALK) crizotinib. Gene via FISH in FFPE non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying patients eligible for treatment with Xalkori (crizotinib). For prescription use only.

    COBAS 4800 BRAF V600 Mutation Test
    Sponsor/Developer: Roche Molecular Systems
    Intended Use/Indications for Use: Intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. Real-time PCR test intended to assist in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

    Herceptest™
    Sponsor/Developer: Agilent Technologies (Dako)
    Intended Use/Indications for Use: Semi-quantitative immunocytochemical assay to determine Her2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Assists in assessment of patients for whom Herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom Perjeta (pertuzumab) treatment is being considered (see Herceptin and Perjeta package inserts); and for patients with Her2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy, for whom Kadcyla (ado-trastuzumab emtansine) treatment is being considered.

    Her2 FISH PharmDx Kit
    Sponsor/Developer: Agilent Technologies (Dako)
    Intended Use/Indications for Use: FISH assay designed to quantitatively determine Her2 gene amplification in FFPE breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Assists in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered; for breast cancer patients for whom Perjeta (pertuzumab) treatment is being considered (see Herceptin and Perjeta package inserts); and for patients with Her2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy, for whom Kadcyla (ado-trastuzumab emtansine) treatment is being considered.

    therascreen KRAS RGQ PCR Kit
    Sponsor/Developer: Qiagen
    Intended Use/Indications for Use: Real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from FFPE colorectal cancer (CRC) tissue. Assists in the identification of CRC patients for treatment with Erbitux (cetuximab) based on a KRAS no mutation detected test result.

  • CDx Under FDA Review

    Qiagen and Boehringer Ingelheim
    Submission announced January 15; agreement announced May 29, 2009 by BI and DxS, since acquired by Qiagen.
    therascreen® EGFR RGQ PCR Kit (therascreen EGFR test), developed by Qiagen for use alongside afatinib (formerly Tovok®), an investigational cancer drug developed by Boehringer Ingelheim and predecessor DxS, and granted Priority Review by FDA as a proposed treatment for patients with locally advanced or metastatic NSCLC, with an EGFR mutation detected by an FDA-approved test. In Europe, diagnostic is CE-marked and available for diagnostic use. In Japan, diagnostic has received regulatory approval.
    Financial terms: Not disclosed.

    Astellas Pharma and Roche (Genentech)
    Submission announced November 20, 2012; agreement announced November 23, 2010, by Roche and OSI Pharmaceuticals, since acquired by Astellas.
    cobas® EGFR Mutation Test, developed by Roche Diagnostics for use alongside Tarceva® (erlotinib), under FDA review for expanded use as a proposed treatment for people with NSCLC whose tumors have EGFR activating mutations. Tarceva is a kinase inhibitor drug co-developed by OSI and Genentech, and initially approved by FDA in 2004.
    Financial terms: Not disclosed.

  • CDx Under Development

    Foundation Medicine and Memorial Sloan-Kettering Cancer Center
    Agreement announced May 2
    Collaboration to co-develop a new molecular diagnostic intended to match patients with blood cancers to targeted therapies or clinical trials. Diagnostic will be based on technology, methods, and computational algorithms developed by Foundation Medicine, which says it intends to commercialize the test internationally. Leukemia, lymphoma, and myeloma specialists at Memorial Sloan-Kettering will provide clinical and genomic expertise to assist in product development. Foundation Medicine said it expects by year’s end to launch the new diagnostic, which will use both DNA and RNA sequencing to identify genomic alterations characteristic of hematologic malignancies. Drugs and specific forms of cancer not disclosed.
    Financial terms not disclosed.

    Abbott (Abbott Molecular) and Epizyme
    Agreement announced April 18
    Companies to co-develop diagnostic for Epizyme drug candidate EPZ-5676, an inhibitor targeting the DOT1L histone methyltransferase for mixed lineage leukemia (MLL-r), a subtype of both acute myeloid leukemia and acute lymphoblastic leukemia. Diagnostic will apply Abbott’s FISH technology to detect MLL genetic alterations that lead to the cancer-causing function of DOT1L. Epizyme will use Abbott's FISH-based diagnostic to help identify eligible patients for EPZ-5676.
    Financial terms not disclosed.

    PrimeraDx and Quest Diagnostics
    Agreement announced March 26
    Nonexclusive agreement to co-develop and commercialize diagnostics that will apply Primera Dx’s ICEPlex System assay-development platform in early-phase biomarker and drug development studies and clinical trials with biotechnology, pharmaceutical, and medical device clients of Quest Diagnostics Clinical Trials. Companies said they expect initial collaborations to focus on cancer, “although they may also explore opportunities in infectious diseases, genetics and other conditions.” Specific drugs and cancer indications not disclosed.
    Financial terms not disclosed.

    Qiagen and Eli Lilly
    Agreement announced February 13
    “Master collaboration” entailing development and commercialization of companion diagnostics that will apply Qiagen’s Rotor-Gene Q platform for use alongside “Lilly investigational and approved medicines across all therapeutic areas.”
    Financial terms not disclosed.

    Agilent Technologies (Dako) and Pfizer
    Agreement announced February 12
    Collaboration to entail “research, development, and commercialization as well as advisory services” in the development of “various” companion diagnostics. Dako specializes in tissue-based cancer diagnostics, though drugs and specific cancer indications were undisclosed.
    Financial terms not disclosed.

    Agilent Technologies (Dako) and Eli Lilly
    Agreement announced January 7
    Master Framework Agreement to develop companion diagnostics “to identify patients who may be more likely to benefit from an investigational oncology medicine currently under development by Lilly.” Drugs and specific cancer indications not disclosed. Oncology is the collaboration’s initial focus. Lilly will be exclusively responsible for development and registration of therapeutics, including clinical trials. Dako will be responsible for developing and registering the diagnostic with FDA.
    Financial terms not disclosed.

    Skuldtech and AB Science
    Plans for companion diagnostic announced November 6, 2012
    Commercialization planned for diagnostic for use alongside the latter’s drug candidate masitinib, an oral tyrosine kinase inhibitor (TKI) for which AB Science has applied to the European Medicines Agency for marketing authorization. Diagnostic will use a set of blood markers discovered by Skuldtech to predict a higher survival rate in pancreatic cancer patients from a drop of blood. Markers discovered during Phase III trial assessing efficacy of masitinib plus gemcitabine—the current standard of care—compared with gemcitabine alone. AB Science will retain full rights to the markers upon FDA marketing authorization of masitinib, which has been designated an orphan drug by FDA and EMA.
    Financial terms not disclosed.

    Qiagen and Bayer HealthCare
    Agreement announced October 25, 2012
    Collaboration where Qiagen will develop, manufacture, and commercialize diagnostics alongside “targeted anticancer therapies developed by Bayer HealthCare, which are currently in early development.” Specific drugs and cancer indications undisclosed. Diagnostics will apply Qiagen’s QIAsymphony platform to identify “specific tumor markers.” Qiagen said the first collaborations will entail development of companion diagnostics to identify patients “who may respond to therapies in clinically unmet disease classifications.” Qiagen also said the companies will also collaborate on development of “technologies for patient profiling which may result in innovative research-use-only products for exploratory and translational medicine.” Over the agreement’s five-year period, Bayer said, it and Qiagen may launch further projects to develop diagnostic tests “in support of additional targeted therapies.”
    Financial terms not disclosed.


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