ASCO

01 JUNE 2018 05 JUNE 2018

ASCO Annual Meeting

Dates: June 1-5, 2018
Venue: Chicago, IL USA
Roche Booth #22097

Roche provides innovative clinical diagnostics and research solutions. Visit Booth #22097 to see how our broad range of technologies can help clinicians make more confident patient management decisions. Learn more about our innovations in liquid biopsy* as well as solutions to support tumor boards.

*Roche NGS liquid biopsy is for Research Use Only. Not for use in diagnostic procedures.

Poster Presentations

Roche Sequencing Solutions will present 5 posters at the upcoming ASCO annual meeting in Chicago. In a retrospective setting, the AVENIO ctDNA analysis kits were used to analyze plasma samples of NSCLC and SCLC research subjects to explore potential research applications. 

For details, please visit us at poster session on June 3rd from 8:00 to 11:30 AM (Abstract #8577 and #3545), and June 4th from 1:15 - 4:45 PM (Abstract #12077, #12088, and #12045).

Product Highlights

AVENIO ctDNA Analysis Kits†
AVENIO ctDNA Analysis Kits are a portfolio of three NGS liquid biopsy assays for somatic oncology.  AVENIO assays detect all four mutation classes (SNVs, indels, CNVs and fusions) with >96% to >99% sensitivity and >99% PPV‡  

  • AVENIO ctDNA Targeted Kit - 17 genes (81kb), guideline-driven biomarkers
  • AVENIO ctDNA Expanded Kit - 77 genes (192kb), guideline-driven and emerging biomarkers
  • AVENIO ctDNA Surveillance Kit - 197 genes (198kb), specially designed and optimized for longitudinal monitoring of tumor burden in lung cancer and colorectal cancer

These ready-to-use kits include reagents, a robust bioinformatics pipeline, and intuitive reports for a streamlined, end-to-end workflow.

The AVENIO Millisect

The AVENIO Millisect System is an automated high-performance FFPE tissue dissection system that can help customers efficiently extract more clinically relevant information from every sample. Optimized to fit easily into a variety of clinical workflow configurations, the AVENIO Millisect System allows precise and consistent recovery of tissue areas of interest for molecular pathology, improving the results of diagnostic testing by reducing false-negatives and allowing identification of additional potential therapeutic targets.

Molecular Assay Offerings
Real-Time PCR products for use on the cobas z 480 analyzer

  • In-Vitro Diagnostic (IVD) products:
    • cobas® EGFR Mutation Test v2
      • Detects 42 EGFR mutations including T790M
      • Companion diagnostic for erlotinib and osimertinib
      • Tissue and plasma sample types
      • Results available in < 1 day
    • cobas® 4800 BRAF V600 Mutation Test 
      • Detects BRAF codon 600 (>85% melanoma BRAF mutation coverage)
      • Tissue sample type
      • Results available in < 1 day
    • cobas® KRAS Mutational Test
      • Detects all major KRAS mutations in codons 12, 13, and 61 from CRC (colorectal cancer) patients
      • Tissue sample type
         
  • Research Use Only (RUO) products:
    • KRAS Mutation Test v2 (LSR)
      • Expanded mutational coverage over cobas® KRAS Mutational Test
      • Tissue and plasma sample types
      • Detects all major mutations in codons 12, 13, and 61, as well as mutations within codons 59, 117, and 146.
    • BRAF/NRAS Mutation Test (LSR)
      • Expanded mutational coverage over cobas® 4800 BRAF V600 Mutation Test, with additional NRAS mutation detection
      • Tissue and plasma sample types
      • Detects 11 BRAF mutations across 4 codons and NRAS mutations across 7 codons.
    • cobas® PIK3CA Mutation Test (RUO)
      • Coverage of 17 mutations in PIK3CA exons 1, 4, 7, 9, and 20
      • Tissue sample type

NAVIFY™ Tumor Board Solution

Diagnostics Information Solutions (DIS) is a dedicated organization within Roche Diagnostics chartered with making Roche Diagnostics the partner of choice to healthcare stakeholders by providing information solutions for better patient care and smarter, more efficient R&D.

Access to data combined with Roche’s background in diagnostics, medicine and biology enables insights that will usher in a new era of patient-centric healthcare through data-driven decision support.

For more information visit - navify.com/insightsnow

See more with the VENTANA MMR IHC panel

Now featuring the exclusive VENTANA BRAF V600E (VE1) antibody

Multiple guidelines including NCCN, ASCO, EGAPP, and NICE1-4 recommend universal screening of all newly diagnosed colorectal cancers for Lynch syndrome with the intent to prevent cancers and save lives.5 The FDA cleared VENTANA MMR IHC Panel aids consists of VENTANA anti-MLH1 (M1), VENTANA anti-PMS2 (A16-4), VENTANA anti-MSH2 (G219-1129), VENTANA anti-MSH6 (SP93), and VENTANA BRAF V600E (VE1) aid in the identification of patients at risk for Lynch Syndrome in patients diagnosed with CRC. The inclusion of the exclusive VENTANA BRAF V600E (VE1) antibody helps refine the number of patients who receive additional testing for Lynch syndrome by aiding in the identification of sporadic CRC in the absence of MLH1 expression.6

  • Consists of 5 assays that identify patients at high risk of Lynch Syndrome
  • Includes VENTANA BRAF V600E (VE1) antibody
  • Features OptiView DAB IHC Detection Kit
  • Is supported by significant performance data, including concordance to NGS
  • Provides interpretation guidance on all 5 assays, including challenging cases
  • US Class II IVD, CE marked

References:

  1. NCCN Guidelines Version 1.2017. Genetic/Familial High Risk Assessment: Colorectal. NCCN Clinical Practice Guideline in Oncology. NCCN.org.
  2. Evaluation of Genomic Applications in Practice and Prevention Working Group. (2009). Recommendations from the EGAPP working group: genetic testing strategies in the
    newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives. Genetics in Medicine, 11(1), 35–41.
  3. ASCO, A.C.A, 2016. Guideline on the Evaluation of Molecular Markersfor ColorectalCancer Expert Panel Draft Recommendations Summary for Open Comment Period
    American Society for Clinical Pathology, the College of AmericanPathologists. the Association for Molecular Pathology, and the American Society of Clinical Oncology
    <http://www.amp.org/committees/clinicalpractice/documents/20150327CRCMMDraftRecommendationsforOCP-UPDATEDfinaldraft 001.pdf>.
  4. NICE, 2017. Molecular Testing Strategies for Lynch Syndrome in People with Colorectal Cancer. National Institute for Health and Care Excellence. http://www.nice.org.uk/guidance/dg27/chapter/1-Recommendations.
  5. Hampel H: Genetic counseling and cascade genetic testing in Lynch syndrome. Fam Cancer 15:423-427, 2016
  6. Roth, R. M. et al. A modified Lynch syndrome screening algorithm in colon cancer: BRAF immunohistochemistry is efficacious and cost beneficial. Am. J. Clin. Pathol. 143,336–343 (2015).

The VENTANA PD-L1 portfolio: guiding immunotherapy decisions
VENTANA PD-L1 assays generate results you can trust, so that you can make timely diagnostic decisions and therapeutic choices. Roche offers two predictive assays designed to identify patients who are most likely to benefit from specific PD-L1 or PD-1 therapies, and supports your expertise by providing you with the tools you need to successfully implement these assays into your laboratory and interpret them proficiently.

  • VENTANA PD-L1 (SP142) Assay gives you the confidence to appropriately identify urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) patients most likely to benefit from TECENTRIQ® (atezolizumab).
  • VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying urothelial carcinoma (UC) patients most likely to benefit from IMFINZITM (durvalumab).

 

VENTANA ALK (D5F3) CDx Assay: Identifying ALK+ NSCLC patients for targeted treatment
Clinical guidelines recommend routine testing for genetic mutations in all adenocarcinomas, including ALK EML4 gene rearrangement. Testing is recommended immediately after establishing histology and is required prior to initiating targeted therapy for a patient. The VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.

  • VENTANA ALK (D5F3) CDx Assay stained with OptiView DAB Detection and Amplification detects the ALK protein that is the target of therapy
  • Clinical guidelines recommend rapid turnaround for earlier targeted therapies
  • ALK has comparable sensitivity and specificity relative to FISH
  • Make more immediate treatment decisions for advanced NSCLC patients by using the VENTANA ALK (D5F3) CDx Assay
  • XALKORI® (crizotinib) ZYKADIA® and ALECENSA® (alectinib) are clinically effective and FDA approved for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved testing method for ALK.1, 2, 3

References

  1. XALKORI (crizotinib) [package insert]. New York, NY: Pfizer; 2012.
  2. ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
  3. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech, 2017.

 

†For Research Use Only. Not for use in diagnostic procedures.

AVENIO, COBAS, COBAS Z, MILLISECT, NAVIFY, OPTIVIEW and VENTANA are trademarks of Roche.

All other product names and trademarks are the property of their respective owners.