Ben Schwartz is Associate Editor, Contemporary OB/GYN.
Other new products discussed in this article include a surgical training model, devices designed to improve prostate biopsy accuracy, an updated label and more.
Test launched to improve prostate biopsy decision process
Cambridge, MA-Exosome Diagnostics, Inc. has launched the ExoDx Prostate (IntelliScore) test, which provides patients and physicians with information that could improve the prostate biopsy decision-making process. The test is the first to use specific genetic information taken from urine samples to provide physicians with a score to help evaluate a patient’s risk for developing more aggressive cancer. It was developed to help reduce the number of unnecessary prostate biopsies and help curb overtreatment of low-grade disease. The test does not require a digital rectal exam and uses a simple urine catch, making it completely noninvasive. It is intended for use in men age 50 years or older with a PSA result of 2.0-10.0 ng/mL.
For more information, visit www.exosomedx.com.
FDA approves sNDA to update labeling of CRPC drug
New York-The FDA has approved a supplemental New Drug Application (sNDA) for enzalutamide (XTANDI) that will update the U.S. product labeling to include new clinical data about how the drug performed against bicalutamide, according to Astellas Pharma Inc. and Pfizer Inc. Based on the phase II TERRAIN Trial, data showed a nearly 40% improvement rate in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide versus those treated with bicalutamide. The enzalutamide group data showed a median rPFS of 19.5 compared with 13.4 months in the bicalutamide group. The trial enrolled 375 chemotherapy-naïve patients with metastatic CRPC and was designed to evaluate patients on a randomized 1:1 basis. The study found the safety profile of enzalutamide to be consistent with previous trials.
For more information, visit www.xtandihcp.com.
New biomarkers help predict response to bladder Ca immunotherapy
Cambridge, MA-Foundation Medicine, Inc. has added new clinical markers to its FoundationOne and FoundationOne Heme products, which are designed to enhance clinicians’ ability to predict response to immunotherapies for urothelial and other cancers. The products provide fully integrated and validated assessments of Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) as a single test to guide personalized immunotherapy-based treatment. At the 2016 ASCO annual meeting, Foundation Medicine presented data from a study showing that three different biomarkers, including TMB, were independent predictors of response to atezolizumab (Tecentriq) in patients with locally advanced metastatic urothelial carcinoma.
For more information, visit www.foundationmedicine.com.
Surgical training model for nephrolithotripsy released
Michigan-Encoris has introduced a surgical training model, PCNL Boz Trainer, which allows surgeons and medical students to practice percutaneous nephrolithotripsy surgery. Using reusable kidney cartridge inserts to simulate different kidney stone conditions, the device provides hands-on simulation for targeting, crushing, and removing kidney stones. The product is reusable and features life-like anatomical markers such as a thoracic spine, thoracic 11th and 12th ribs, and life-like skin with subcutaneous tissue layers.
For more information, visit www.encoris.com.
Two devices designed to improve prostate biopsy accuracy
New York-Axella BioVentures and UC-Care have released the Navigo and SmartBx Systems, two devices to assist physicians with performing more accurate prostate biopsies. Navigo (shown) helps physicians to plan, place, image, and record biopsy samples in high-resolution 3-D modeling even without the use of an MRI. It allows the fusion of past and present biopsy procedures and can assist physicians with executing a follow-up biopsy in men undergoing active surveillance. The Smart Bx Prostate Biopsy system helps manage and preserve prostate biopsies acquired with transrectal ultrasound. Biopsy cores can be downloaded with accurate orientation to assist a pathologist’s assessment of tumor location. The device maintains the specimen as a single, unbroken tissue, which allows for better processing and stronger cancer diagnosis, according to the companies.
For more information, visit www.uc-care.com.
Expanded version of prostate tumor profiling report launched
San Diego-GenomeDx Biosciences has launched an expanded version of its decipher GRID Tumor RNA Expression Profile, a report that is generated for prostate tumors profiled with the company’s Decipher Prostate Cancer Classifier test. The report analyzes genomic data points from a patient’s tumor and analyzes molecular pathways and genomic signatures. The GRID Tumor RNA Expression Profile supplies research-use-only information to physicians for every tumor profiled with Decipher Prostate Cancer Classifier. The tool is a cloud-based genomic data-sharing and collaborative research platform and contains over 27,000 tumor profiles, many of which are being tested in clinical trials. GenomeDx hopes that eventually the GRID Tumor RNA Expression Profile can be used to help physicians personalize the care of their prostate cancer patients. Separately, GenomeDx announced that it has entered into a marketing agreement with Bostwick Laboratories, under which Bostwick will offer Decipher Biopsy on its requisition forms, allowing for electronic ordering of the test.
For more information, visit www.genomedx.com/decipher-test/.
Video center helps patients, physicians understand treatment options
Des Moines, IA-Rational Surgical Solutions (RSS) has introduced the Rati-Fi-PreOp Urology Video Center to educate patients about treatments for common urologic conditions. Using video, the Rati-Fi system provides patients with medical animations explaining their treatment options. After viewing the videos, patients are tested with a brief quiz, and a video-based informed consent process records the consultation with the doctor. RSS currently offers physicians the opportunity to download a free sample video on laser vaporization of the prostate.
For more information, visit www.rati-fi.com.
Antibody test assists in diagnosis of Zika virus
Madison, NJ-Quest Diagnostics has released an antibody test service to assist in the diagnosis of Zika virus infection. The test is based on the CDC’s Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA). The CDC has licensed the test to Quest, as well as additional select national reference laboratories, to help address the Zika situation in the United States. Quest was the first commercial laboratory to receive FDA emergency use authorization for a Zika test and the company later expanded its molecular Zika test capabilities by introducing an RT-PCR Zika test service for the qualitative detection of Zika RNA in serum and paired urine specimens. The RT-PCR testing is most effective up to 2 weeks after the onset of symptoms and IgM testing is most effective 2 to 12 weeks after symptoms.
For more information, visit www.questdiagnostics.com