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Sanofi Announces Upcoming Launch of MyStar Extra, the First Self-Monitoring Blood Glucose Meter With Estimated A1c

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) recently presented the innovative blood glucose meter MyStar Extra®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control.[3],[4] The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions.[5],[6] Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.[7],[8],[9]

The Ongoing Collaboration Aims to Exploit the High Throughput, Robustness and Ease of Use of MALDI-TOF Instruments

At the 12th HUPO World Congress, Bruker Corporation (NASDAQ: BRKR) recently announced the start of a second-phase collaboration agreement with SISCAPA Assays Technologies, Inc. (SAT). The ongoing collaboration aims to exploit the high throughput, robustness and ease of use of MALDI-TOF instruments as an alternative to nano-LC-MS technology currently used in many SISCAPA assays.

Crescendo Bioscience to Present New Data on Vectra DA Use to Assess Radiographic Progression Risk in Patients with Rheumatoid Arthritis Treated with Traditional and Biologic Therapies at the European League Against Rheumatism Annual Meeting (EULAR)

Crescendo Bioscience, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other auto-immune diseases, announced today that it will present data from ten different studies that further support the important role Vectra® DA can play in managing Rheumatoid Arthritis (RA) at the European League Against Rheumatism (EULAR) Annual Meeting held in Madrid, Spain, on June 12-15. EULAR is the largest gathering of rheumatology healthcare professionals in Europe. Vectra DA is an objective, validated blood test that provides rheumatologists with a score of 1-100, giving biological insight into the level of disease activity of rheumatoid arthritis. Data presented at EULAR will demonstrate Vectra DA’s ability to assess risk of radiographic progression (joint damage over time) in patients with RA currently treated with traditional and biologic agents, including TNF inhibitors. In addition, data will show how Vectra DA can detect a high level of RA disease activity in patients with a low C-reactive protein (CRP) without being affected by fibromyalgia, a painful non-inflammatory condition that can co-exist with RA.

This week, researchers will present data from a study conducted by the University of Occupational and Environmental Health in Kitakyushu, Japan, A Multi-biomarker Disease Activity (Vectra DA Algorithm) Score is Associated with Radiographic Outcomes in RA Patients Treated with TNF inhibitors (#SAT0012) . This study found that patients who were being treated with adalimumab, etanercept or infliximab and had a low Vectra DA score (29 or less) in at least two of three visits over one year showed little or no radiographic progression. In contrast, patients with high scores (greater than 44) for at least two of three visits had a much higher risk of clinically relevant radiographic progression. In addition, researchers found that change in the Vectra DA score over the first six months of treatment correlated with radiographic outcomes in the first year. This is the first time risk of radiographic progression in patients treated with TNF inhibitors was assessed using Vectra DA over time.

“We know that anti-TNF drugs have been shown to help minimize the overall amount of radiographic progression,” said Yoshiya Tanaka, MD, PhD, Professor and Chairman, University of Occupational and Environmental Health, Kitakyushu, Japan. “This study underscores the clinical utility of Vectra DA to objectively assess which patients remain at risk of radiographic progression despite anti-TNF therapy. This information could be important in helping rheumatologists confirm or potentially revise their treatment plan.”

“This study demonstrates the additional value Vectra DA can bring to the overall RA patient management experience,” said Oscar Segurado, MD, PhD, Chief Medical Officer at Crescendo Bioscience. “With a number of RA drugs available today, and more than 50 agents in development, a quantifiable disease activity measurement test like Vectra DA can be a true asset for physicians.”

Researchers will also present new data regarding use of Vectra DA in patients with both RA and fibromyalgia. In Application of a Multi-Biomarker Disease Activity (Vectra DA) Score for Assessing Rheumatoid Arthritis Patients with Low CRP or Fibromyalgia (#SAT0099), researchers from the Brigham and Women’s Hospital and Harvard Medical School showed that in patients with RA, traditional methods of disease assessment, including tender joint count, DAS28-CRP, and Patient Global Assessment were markedly increased by the presence of fibromyalgia, a painful non-inflammatory syndrome that can confound the assessment of patients with RA. In contrast, the Vectra DA test measured essentially the same level of disease activity in patients with RA independent of the presence of fibromyalgia, which highlights the value of the objective nature of the test.

“Vectra DA provides additional information about disease activity that is not provided by other assessment tools such as C-reactive protein (CRP),” said Segurado. “This study showed that in patients with low CRP, nearly half had Vectra DA scores in the moderate to high disease activity range, indicating that their RA was actually more active than originally found with CRP. This information will help physicians attain better insight to the underlying biology of the disease.”

Additional Poster Highlights

A study selected by EULAR will be part of the Poster Tour (FRI0098) Friday, June 14 between 11:45 am and 1:30 pm, Biomarker-Based Estimates of Risk of Radiographic Progression in the Leiden Early Arthritis Cohort, and researchers from the Leiden University Medical Center, Leiden, the Netherlands will discuss the use of Vectra DA as a tool to estimate the risk of radiographic progression in RA.

“Using the Vectra DA score, we were able to see a correlation between the score and risk of radiographic progression over 12 months,” said Tom W.J. Huizinga, M.D., Head of the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands and primary investigator. “This tells us that Vectra DA can be helpful in identifying patients at high risk for radiographic progression and, thus, give rheumatologists more information to help prevent future progression.”

Another poster, A Multi-Biomarker Disease Activity Blood Test (Vectra DA) Correlates with Radiographic Progression in Early Rheumatoid Arthritis: Results from the SWEFOT Trial (#FRI0060), focused on use of Vectra DA in assessing risk of radiographic progression in early RA. The SWEFOT study is the Swedish Pharmacotherapy Trial out of the Karolinska Institutet in Stockholm.

In early RA patients starting methotrexate, the study found that Vectra DA’s score, when assessed at baseline, significantly correlated with radiographic progression in the first year. “A high MBDA score at baseline was associated with a higher risk of radiographic progression, even in patients who had moderate disease activity by DAS28 or low CRP at baseline,” said Ronald F. van Vollenhoven,M.D., Ph.D., Professor and Chief, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Chief, Clinical Trials Unit, Department of Rheumatology, the Karolinska Institute and primary investigator of the study.

Other Vectra DA Posters Presented at 2013 EULAR Annual meeting

Additional study results (presented in six posters listed below) further demonstrate and confirm the ability of Vectra DA to objectively assess disease activity and/or potentially identify risk for radiographic progression in early- and later-stage RA patients.

Poster #FRI0061

Multi-Biomarker Disease Activity (MBDA) Score and the 12 Individual Biomarkers in Early Rheumatoid Arthritis Patients Relate Differently to Clinical Response and Radiographic Progression: Results from SWEFOT Trial; K. Hambardzumyan, Karolinska Institutet, ClinTRID, Stockholm, Sweden, and other collaborators.

Poster #FRI0062

Evaluation of a Multi-Biomarker Disease Activity (Vectra DA Algorithm) in Early Rheumatoid Arthritis and Unclassified Arthritis Patients; K. I. Maijer, Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, the Netherlands and other collaborators.

Poster #FRI0066

Behavior of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components in Patients with Rheumatoid Arthritis Treated with Tocilizumab; K. Hanami, The First Department Of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, and other collaborators.

Poster # FRI0075

A Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components are Associated with Sustained Clinical Remission in Rheumatoid Arthritis: the REMIRA Study; M. H. Ma, Academic Department of Rheumatology, King’s College London, London, United Kingdom and other collaborators.

Poster #FRI0079

Response to MTX Plus Prednisone in CAMERA II Using a Multi-Biomarker Disease Activity Test (Vectra DA) and DAS28-ESR; M. S. Jurgens, Rheumatology & Clinical Immunology, UMC UTRECHT, Utrecht, Netherlands and other collaborators.

Poster #SAT0033

Characterization of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score in a Subgroup of Patients from the Epidemiological Investigation of Rheumatoid Arthritis (EIRA) Cohort Receiving Methotrexate; W. Li, Crescendo Bioscience, Inc., South San Francisco and other collaborators.

Source: GlobeNewswire

AAPA Poster Presentation Explores Connection between Biomarkers and Science-Based Personalized Nutrition Therapy in the Management of Major Depressive Disorder

An examination of the latest genetic and physiologic biomarker research and its application in viable therapeutic options for patients with Major Depressive Disorder (MDD) was the focus of a breakthrough poster presentation which debuted at the American Academy of Physician Assistants (AAPA) annual conference, IMPACT 2013. The poster and complete study findings were presented by Ian V. Mackey, M.S., P.A.-C, Physician Assistant, Rush University Medical Center.

Building on data that shows obesity and inflammation predict poorer response to antidepressant therapy, the poster shed light on the link between biomarkers associated with conditions of inflammation, oxidative stress, and obesity and a patient’s potential response to treatment with adjunctive L-methylfolate. The presentation was aimed at helping inform and educate physician assistants (PA), who are often the first line of defense for patients presenting with MDD and critical to the proper treatment of the condition. The poster findings also come on the heels of a study published in the American Journal of Psychiatry which demonstrated twice as many patients responded when given adjunctive L-methylfolate 15mg compared to adjunctive placebo (continuation of SSRI monotherapy). In terms of tolerability, discontinuations due to adverse events were no different than placebo when adding L-methylfolate to SSRI treatment in patients with MDD.

“It’s vital that we make it a practice to assess the patient as a whole as opposed to assessing just their symptoms of MDD,” said Ian Mackey, M.S., P.A.-C. “As these findings indicate, other medical problems, concomitant medications and inflammation are becoming increasingly important in choosing the correct interventions for patients with MDD.”

Taking into account MDD can include metabolic components associated with poor Selective Serotonin Reuptake Inhibitors (SSRI) response, the poster presentation, Effect of L-methylfolate on Inflammatory Markers a Randomized Clinical Trial of Patients with Major Depression, analyzed 75 outpatients inadequately responding to an SSRI who were enrolled in a 60-day study, divided into two, 30-day evaluation periods according to Sequential Parallel Comparison Design (SPCD). Patients were randomized to receive L-methylfolate 15mg + SSRI for 60 days; placebo + SSRI for 30 days followed by L-methylfolate 15mg + SSRI for 30 days; or placebo + SSRI for 60 days. The SSRI doses remained constant during the study. Pooled 30-day results demonstrated significantly greater benefits in all-comers with adjunctive L-methylfolate 15mg + SSRI compared to placebo + SSRI (continued SSRI monotherapy). The magnitude of difference between response to adjunctive L-methylfolate and adjunctive placebo was 17.7% (p=0.04). Pooled differences in mean change on HDRS-17 and HDRS-28 were significantly greater (p=0.05 and p=0.02 respectively) with L-methylfolate superior to placebo.

Results also show that patients with SSRI-resistant MDD stratified by biomarkers of inflammation (hsCRP), oxidative stress (4-HNE) and methylation (SAM/SAH ratio) responded better to adjunctive L-methylfolate 15mg compared to adjunctive placebo. In an analysis of a priori endpoints, patients with baseline levels of hsCRP at or above the median (p=0.05) and 4-HNE (p=0.003) at or above the median and SAM/SAH ratio below the median (p=0.005) experienced a significantly greater treatment effect in favor of adjunctive L-methylfolate. In an exploratory analysis, patients with obesity defined as BMI ≥30 kg/m2 demonstrated a significantly greater treatment effect with adjunctive L-methylfolate versus adjunctive placebo (p=0.001).

The AAPA’s annual conference is focused on identifying and discussing innovative solutions that empower PAs at all stages of their careers to improve patient health. IMPACT 2013 remains the largest PA-focused Continuing Medical Education (CME) event in the world, with approximately 6,000 PAs and students in attendance. IMPACT 2013 took place May 25-29 at the Walter E. Washington Convention Center in Washington, D.C.

Source: Business Wire

bioTheranostics To Present Data on CancerTYPE ID and Breast Cancer Index at 2013 ASCO Annual Meeting

bioTheranostics, Inc., a leading provider of molecular diagnostic solutions for cancer, recently announced that 11 data presentations will be released during the American Society of Clinical Oncology (ASCO) annual meeting May 31–June 4, 2013, in Chicago. The studies highlight the clinical utility of the company’s CancerTYPE ID® assay and Breast Cancer IndexSM (BCI), with results supporting the role of these molecular tests in individualized treatment programs for cancer patients.

bioTheranostics also will host an Industry Expert Theater educational presentation titled, “Demanding Certainty in Metastatic Cancer Diagnosis: The Clinical Impact of
CancerTYPE ID®,” June 2, 2013, at 11:30 a.m. The company’s products will be demonstrated at booth #23041.

“These studies are part of a large and growing body of clinical evidence demonstrating the positive impact our CancerTYPE ID and Breast Cancer Index molecular tests have on the management of cancer patients,” said Richard Ding, president and CEO of bioTheranostics. “The data provide key insights into the value of our molecular tests in influencing clinical decision making and impacting patient outcomes and healthcare costs, and we look forward to sharing and discussing the results during the 2013 ASCO meeting.”

The studies were conducted by researchers at leading institutions, including Linköping University (Sweden); Louisiana State University Health Sciences Center; Massachusetts General Hospital; Sarah Cannon Research Institute; University of California, San Francisco, School of Medicine; University of Kentucky; University of Pittsburgh Medical Center; and the University of Texas MD Anderson Cancer Center.

CancerTYPE ID Posters & Abstracts

  • Poster presentation: Molecular tumor profiling (MTP) of poorly differentiated neoplasms (PDN) of unknown primary site. Greco FA, et al. Abstract #11080.
  • Multivariate analysis of prognostic factors in cancer of unknown primary (CUP) patients treated with site-specific therapy based on the 92-gene cancer classifier. Schnabel CA,
    et al. Abstract #e15006.
  • Impact of the 92-gene assay on cost of diagnosis of tumor type in metastatic cancer of uncertain origin. Bentley TG, et al. Abstract #e15104.
  • Effect of the 92-gene molecular classifier on therapeutic decision-making in cancers of uncertain primary. Schroeder B, et al. Abstract #e15130.
  • Use of the 92-gene assay to identify tumor type and direct predictive biomarker testing in limited tissue specimens. Operana TN, et al. Abstract #e19072.
  • Poster presentation: Diagnostic utility and prognostic performance of a 92-gene cancer classifier to molecularly profile periampullary adenocarcinomas (PAA). Overman MJ, et al. Abstract #4133.
  • Renal cell carcinoma (RCC) presenting as cancer of unknown primary (CUP): Diagnosis by molecular tumor profiling (MTP). Hainsworth JD, et al. Abstract #e15501.
  • Poster presentation: Gene expression profiling (GEP) to predict the primary site of metastatic neuroendocrine tumors (NETs) presenting with an unknown primary. Woltering E, et al. Abstract #4141.
  • Confirmation of non-small cell lung cancer (NSCLC) diagnosis using ALK testing and genetic profiling in patients presenting with carcinoma of unknown primary site (CUP). Penley WC, et al. Abstract #e19062.

Breast Cancer Index Poster & Abstract

  • Poster presentation: Prediction of early and late distant recurrence in early-stage breast cancer with Breast Cancer Index. Zhang Y, et al. Abstract #594.
  • Health economic analysis of Breast Cancer Index in patients with ER+, LN- breast cancer. Gustavsen G, et al. Abstract #e11504.

Abstracts for the 11 studies concerning bioTheranostics’ molecular tests can be accessed on the ASCO website.

Source: bioTheranostics