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Surveys Reveal Opportunity for Medical Community to Fully Embrace Biomarker Testing in Lung Cancer

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced results of two surveys that explored how pulmonologists and pathologists are incorporating biomarker testing into the care of patients with lung cancer. The results point to an increased role of these physicians in biomarker testing as well as greater multidisciplinary collaboration. However, they also reveal that an opportunity exists to improve how soon these tests are requested and to identify challenges with testing, including collecting a sufficient amount and quality of lung tissue.

Biomarker testing – the practice of testing tissue for a specific genetic mutation or translocation, known as a biomarker – is critical in the diagnosis of lung cancer, as it helps physicians determine a patient’s specific type of cancer and inform a personalized treatment approach.

“These surveys provide perspective on the continued need for a multidisciplinary approach to biomarker testing to ultimately support personalized care of patients with lung cancer,” said William Goeckeler , PhD, director, Oncology Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Automatic biomarker testing is critical for an accurate diagnosis as it helps match each patient with the most appropriate therapy as early as possible.”

The surveys were sponsored by BIPI and conducted online by Harris Interactive in November and December 2012. The first survey consisted of 100 pulmonologists practicing in the U.S. and the second consisted of 250 pathologists practicing in the U.S.

Differing Perspectives on Testing

Survey responses revealed the need for consistent guidelines on the size and quality of tissue needed to perform biomarker testing.

  • Both pulmonologists and pathologists said the biggest challenges with biomarker testing include not always acquiring a tissue sample that is sufficient in size (60% and 73%, respectively) or quality (31% and 39%, respectively).
  • About half of pulmonologists (41%) do not believe they have enough information about the size of tissue needed.

These findings are similar to results of a previous BIPI survey from 2011 of 95 community oncologists, also conducted online by Harris Interactive: nearly half (42%) stated they did not have sufficient information about the tissue sample size needed to test for a certain mutation.

The recent surveys also highlighted a difference of opinion around the most appropriate tissue acquisition methods. For example:

  • Fifty-one percent of pulmonologists surveyed believed endoscope biopsy to be the method yielding the most appropriate balance between quantity and quality of tissue and risk to the patient; just 15 percent of pathologists agreed.
  • One-third of pulmonologists (33%) believed fine needle aspiration to be the best method; only 10 percent of pathologists agreed.
  • Interestingly, 63 percent of pathologists and 44 percent of pulmonologists believe core biopsy to be the most appropriate method.

Opportunity for Greater Adoption of “Reflex” Testing

Through reflex – or automatic – testing, tissue samples are tested for biomarkers immediately after a non-small cell lung cancer (NSCLC) diagnosis. This way, oncologists receive the results at the patient’s first visit, with the goal of initiating the most appropriate therapy as early as possible. The results from surveyed pulmonologists and pathologists suggest that they have started to embrace reflex testing, but there is a potential to increase its use:

  • Nearly half (43%) of pulmonologists implement reflex testing of NSCLC patients in their practice or local healthcare community.
  • One-third of pathologists (33%) say such reflex testing has been implemented in their practice.

Biomarker testing has significant implications for patients because, as revealed in the 2011 survey of community oncologists, of those who said they order biomarker testing, 89 percent (78/88) stated that genetic mutation testing helps with treatment decisions. All of the 95 community oncologists surveyed plan treatment differently for lung cancer patients who have a genetic mutation.

The Growing Role of the Multidisciplinary Team

A multidisciplinary approach to a patient’s lung cancer diagnosis is important, as it can help streamline the testing process and personalize treatment decisions. Results from surveyed pulmonologists and pathologists suggest that they are increasingly utilizing a multidisciplinary approach – which is good news for patients:

  • Pulmonologists and pathologists report having increased discussions with a multidisciplinary team over the past five years (65% and 57%, respectively).
  • Majorities of pulmonologists and pathologists consult with oncologists (85% and 92%, respectively).

“The medical community is moving in a positive direction, but an opportunity exists for greater collaboration in incorporating biomarker testing into a patient’s care early on, with the goal of initiating an appropriate lung cancer treatment plan as soon as possible,” said Kevin Lokay , vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “We are proud to be part of this movement, and it is encouraging to see how this multidisciplinary approach to testing is already having a significant impact on the diagnosis and care of cancer patients.”

The surveys complement BIPI’s Let’s Test initiative, which aims to educate healthcare professionals about the important role they play in the diagnosis and treatment of NSCLC, and the critical role of biomarker testing. The initiative, which also highlights the need for a multidisciplinary approach, demonstrates Boehringer Ingelheim’s commitment to advancing the care and outcomes for patients with cancer.

Source: PR Newswire

New Article in PLOS Currents: Evidence on Genomic Tests Supports Use of Veracyte’s Afirma Gene Expression Classifier to Resolve Ambiguous Thyroid Nodule Biopsies

Veracyte, Inc. recently announced that a new review article published in PLOS Currents: Evidence on Genomic Testsconcludes that published studies and independent assessments and reviews of the Afirma Gene Expression Classifier support the test’s use to help resolve inconclusive results on thyroid nodule fine needle aspiration (FNA) samples, and thus help patients avoid unnecessary surgery as part of thyroid cancer diagnosis. The findings also reinforce recent guidelines from the National Comprehensive Cancer Network (NCCN) recommending that physicians consider using molecular testing in lieu of diagnostic surgery for patients with ambiguous thyroid nodule FNA results – provided the test’s performance is similar in accuracy to a benign diagnosis by cytopathology.

The authors determined that the clinical and analytical validation studies used to evaluate the Afirma Gene Expression Classifier were consistent with the stringent, Level 1 evidence criteria for study design and implementation standards established by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP), an initiative of the U.S. Centers for Disease Control’s Office of Public Health Genomics. The second and larger prospective clinical validation study involved 49 academic and community sites and found that when the genomic test reclassified indeterminate-cytology thyroid nodule FNA samples as benign – which it did more than half of the time – its accuracy was similar to a benign diagnosis using cytopathology. The new review article also evaluated the published literature regarding the test’s clinical utility, as well as technology assessments/guidelines by independent parties and professional groups, such as the national contractor that administers Medicare benefits and the NCCN.

“This new review paper helps to further establish the Afirma Gene Expression classifier as a valuable tool for helping thyroid nodule patients avoid unnecessary surgery, while also removing costs from the healthcare system,” said Bonnie Anderson, cofounder and chief executive officer of Veracyte. “It also supports the growing use of the test among community-based endocrinologists and leading academic institutions around the country.”

Thyroid cancer is the fastest-increasing cancer in the United States, with 60,220 new cases expected in 2013, according to the American Cancer Society. Approximately 450,000 thyroid nodule FNAs – a minimally invasive procedure to extract cells for examination under the microscope – are performed each year in the U.S. to rule out cancer. However, in 15% to 30% of cases, the results are inconclusive, and current protocols typically recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients turn out to have benign nodules.

Study: Use of the Afirma® Gene Expression Classifier for Preoperative Identification of Benign Thyroid Nodules with Indeterminate Fine Needle Aspiration Cytopathology

Source: Veracyte

Quest Diagnostics Launches New Molecular Test Panel for Enhanced Thyroid Cancer Detection

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced a new molecular test panel designed to help physicians determine if a thyroid gland is cancerous and requires surgical removal. The test is believed to be the most comprehensive panel clinically available to identify mutations associated with four gene markers indicated by the American Thyroid Association for the clinical management of indeterminate thyroid biopsies.

Results of a Multi-center Study Show microRNA-based Pancreatic Cancer Assay Improves the Diagnostic Accuracy of FNA Cytology

Asuragen, Inc. announced today that data from a multi-center study evaluating its microRNA-based test, miRInform Pancreas, for the diagnosis of pancreatic ductal adenocarcinoma (PDAC) in fine needle aspirates, was presented as a Poster of Distinction at the American Pancreatic Association (APA) Annual Meeting being held November 2-5, 2011 in Chicago.