FDA approves first HPV test for cervical cancer screening
SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a human papillomavirus DNA test for women 25 years of age and older that can be used alone to help health care professionals assess the need for a woman to undergo additional testing for cervical cancer. The Cobas HPV test is the first and only HPV test approved for primary screening in the United States.
The test uses a sample of cervical cells to specifically identify HPV 16 and HPV 18, while also detecting 12 other types of high-risk HPVs.
“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”
Based on results of the Cobas HPV test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam that uses a device to illuminate and magnify the cervix so a physician can observe the cervical cells. Women who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.
The Cobas HPV test is manufactured by Roche Molecular Systems, which is based in Pleasanton, Calif.
Armada Health Care launches new web application solution for specialty pharmacy industry
FLORHAM PARK, N.J. — Armada Health Care, a provider for channel management solutions, commercialization strategies, and support services for the specialty pharmaceutical industry, has announced the launch of a new specialty pharmacy software solution called Vision Armada Analytics.
The tool, which supports multiple pharmacy platforms for API integration, tracks a specialty drug’s path prior to initiation of treatment (pre-dispensed data), during the intake and referral processes, and after the drug has been dispensed. The new platform also allows specialty pharmacies to measure and validate a patient’s response to therapy.
The module can offer access to drug dispensing data, drug utilization data, and de-identified patient demographic data that can be utilized by various interested stakeholders: specialty pharmacies, pharmaceutical manufacturers, home infusion pharmacies, payers, pharmacy retailers, physicians, hospitals, and other health care groups tracking adherence and specialty drug compliance, the company stated.
Vision was developed to provide a real-time drilldown of how and where prescriptions are being filled to allow for better management of patients and specialty products. The web-based interface provides data about patient intake, days-to-fill, sales and dispensing information. Other capabilities include hub-based data capturing, tools for predictive analysis, spreadsheet exports, messaging and notifications.
"The Vision module enables pharmacies to perform real-time data analysis through a secure, HIPAA-compliant connection," stated Howard Barsky, chief information technology officer at Armada Health Care. "With Vision, we are able to provide true metrics for pharmacies and manufacturers to help them perform pre-dispensed data workflow analyses within a platform tightly integrated with our other proprietary tools: the ReachRx Online Therapy Management web application, Armada’s Specialty Pharmacy Network, and ApproveRx, our comprehensive prior authorization program."
Vision’s pre- and post-claims data can be used as a marker of patient adherence and compliance levels that health care providers can monitor through the program’s dashboard in order to anticipate and mitigate potential barriers to proper treatment with complex biologics, the company stated. These metrics may also help manufacturers make conclusions about usage and help company brand teams formulate sales strategies based on utilization and reimbursement trends on a region-by-region basis. In addition, the Vision Armada Analytics application also offers visibility into the insurance plan benefit design and co-pay programs associated with a specialty therapy.
Baja Blast makes trip from Taco Bell to store shelves
PURCHASE, N.Y. — Mountain Dew, a brand from PepsiCo, on Thursday announced that for the first time, Mtn Dew Baja Blast — which is only available as a fountain beverage at Taco Bell — will make the leap to store shelves for a limited time beginning May 5.
"Mtn Dew Baja Blast has been a fan-favorite for 10 years, and we’re thrilled for this first-time opportunity to make it available on store shelves this summer," said Greg Lyons, VP marketing, Mountain Dew. "We’ve been humbled by the amount of speculation and consumer buzz around Mtn Dew Baja Blast being bottled and are confident that this limited time offer is going to be a blockbuster!"
Mtn Dew Baja Blast is the second largest and fastest growing fountain beverage sold at Taco Bell and sparked more than 30,000 mentions on Twitter in the past three years.
"Every week, 36 million people come to Taco Bell and see – or buy – Mtn Dew Baja Blast, and now we’re able to expand our reach of this fan-favorite to millions more," said Chris Brandt, CMO, Taco Bell. "We are all about putting a twist on the traditional, from innovative menu items to exclusive Taco Bell beverages, which is why we’ll continue to work with our partners at PepsiCo to find and create the best experiences for our customers."
Mtn Dew Baja Blast will be available in single-serve 20-oz. bottles and 24-oz. cans, as well as 12-packs for 12-oz. cans.