December 2011

News read or heard lately

Galectin-3 and heart failure readmission

Heart failure patients who had elevated galectin-3 levels at the time of initial discharge from the hospital or emergency department for heart failure were hospitalized again for heart failure in the subsequent 90 days at a rate that was two to three times higher than for the patients with lower galectin-3 levels. That’s according to the results of a study presented in September at the annual meeting of the Heart Failure Society of America.

The presentation at the meeting was titled “Plasma galectin-3 is associated with near-term rehospitalization in heart failure: a meta-analysis” and presented by Rudolf de Boer, MD, PhD, associate professor of cardiology at the University of Groningen, the Netherlands. Galectin-3 levels in the study were measured using the BG Medicine galectin-3 test, a blood test the Food and Drug Administration cleared recently.

The study included heart failure patients from three cohorts consisting of 892 patients: the Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) study, the Pro-BNP Investigation of Dyspnea in the Emergency Department (PRIDE) study, and the University of Maryland Pro-BNP for Diagnosis and Prognosis in Patients Presenting with Dyspnea study. All study patients were enrolled, and blood samples obtained, upon presentation to an emergency department or upon discharge for a heart failure-related hospital stay. The results indicated that patients with galectin-3 levels above 17.8 ng/mL at enrollment were significantly more likely to be rehospitalized in the near-term after initial discharge.

“Reducing rehospitalizations for heart failure patients has become one of the health care priorities,” said James L. Januzzi, MD, of Massachusetts General Hospital, one of the study’s authors. “These results suggest that measuring galectin-3 in the hospital may offer clinicians, hospitals, and payers the opportunity to identify patients at highest risk for readmission and tailor their interventions to offer those at highest risk the most advanced interventions.”

CUP test and colorectal cancer outcomes

BioTheranostics, a BioMérieux company that develops diagnostic oncology tests, announced clinical study findings that link its CancerType ID molecular test with improved patient outcome. Patients in whom the 92-gene molecular classification CancerType ID test predicted a colorectal site of origin and who subsequently received site-specific therapy had a median survival three times that of what has been reported in patients treated empirically for cancer of unknown primary.

CancerType ID has been shown to discriminate among tumor types that pose diagnostic dilemmas, including neuroendocrine subtypes often associated with metastasis. The test classifies 30 main tumor types, 54 subtypes, and 106 different morphologies, covering more than 95 percent of all solid tumors.

John Hainsworth, MD, of Sarah Canon Research Institute, Nashville, Tenn., led the retrospective study of treatment outcomes in patients with carcinoma of unknown primary and a colorectal cancer molecular profile. It focused on the improved treatment response and survival in a group of patients in which CancerType ID results were used to select site-specific therapy. According to the findings, which are online (www.clinical-colorectal-cancer.com/article/S1533-0028(11)00124-1/abstract) and published in this month’s issue of Clinical Colorectal Cancer, 75 percent of the patients showed negative colonoscopy results, and about half of the patients had atypical immunohistochemistry for colorectal cancer. CancerType ID was used as part of the routine workup, and site-specific treatment was selected based on the molecular assay prediction.

The results demonstrated a 50 percent response rate in patients treated with first-line regimens for colorectal cancer versus 17 percent in patients treated with current empiric therapies for cancer of unknown primary. Patients predicted to have colorectal cancer by CancerType ID and treated with colorectal cancer treatment regimens had a median survival of 27 months. In comparison, patients treated with empiric cancer of unknown primary treatment have historical median survivals of eight to 11 months.

Life Tech to develop companion test

Life Technologies has signed an agreement with GlaxoSmithKline Biologicals S.A. (GSK) to develop a diagnostic to be used as a companion test with a GSK candidate cancer immunotherapy. Life Tech will develop a qPCR-based molecular diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the immunotherapy.

MAGE-A3 candidate immunotherapy is being evaluated in two clinical trials. MAGRIT, the phase three clinical lung cancer treatment study, is evaluating MAGE-A3’s efficacy and safety as an adjuvant treatment in resected non-small cell lung cancer. The phase three clinical study DERMA is evaluating its efficacy and safety as an adjuvant treatment in patients whose melanoma has invaded lymph nodes.

FDA-cleared HER2 algorithm application

Ventana Medical Systems received FDA 510(k) clearance for its Companion Algorithm HER2 (4B5) application, which is run within the company’s Virtuoso digital pathology software.

The Companion Algorithm HER2 assists in the detection and semiquantitative measurement of HER2 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue and helps ensure consistency and objectivity in interpretation.

When used with the company’s Pathway anti-HER2 (4B5) rabbit monoclonal primary antibody, the Companion Algorithm HER2 application is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin (trastuzumab) treatment is being considered. The 510(k) clearance covers all components of the workflow, including the 4B5 clone, slide stainer, detection systems, software, and scanner.

Ventana also received FDA 510(k) clearance for its digital read application, which allows pathologists to view HER2 (4B5) stained slides as images on a computer monitor with Virtuoso software and the iScan Coreo Au scanner.

Making HIV tests compatible with NGS

Siemens Healthcare Diagnostics and Illumina have entered into a partnership through which the companies plan to make Siemens’ molecular HIV tests compatible with Illumina’s MiSeq next-generation sequencing platform, with the goal of introducing sequencing-based infectious disease assays for the clinical diagnostics market.

Siemens launched its Trugene HIV-1 genotyping assay 10 years ago. By making it compatible with MiSeq, Siemens is aiming to help labs leverage next-generation sequencing.