Category Archives: AZBio News

Ventana Announces HER2 Companion Diagnostic to Identify Breast Cancer Patients for Roche’s Latest Targeted Medicines

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Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, has announced the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic1 for detecting HER2 protein expression for patients who, in countries where they are approved, may be appropriate candidates for Perjeta® (pertuzumab) and Kadcyla™ (ado-trastuzumab emtansine). Previously, the VENTANA HER2 (4B5) test was labeled only for the identification of HER2-positive breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered.

“In line with our mission to improve the lives of all patients afflicted with cancer, our HER2 assay will continue to provide important diagnostic information for breast cancer treatment decisions,” says Mara G. Aspinall, President, Ventana Medical Systems, Inc. “We are proud to be the preferred tissue diagnostics partner for our Roche Pharma colleagues. This announcement also signifies the unique ability of Roche to deliver healthcare to cancer patients worldwide.”

Breast cancer is the most common cancer worldwide for women2 and the second leading cause of female cancer-related deaths3. Approximately one-fifth of breast cancers are classified as HER2- positive and if left untreated are associated with poorer clinical outcomes4. Defining HER2 status allows the treatment team to better identify which patients may be appropriate candidates for a treatment regimen with a HER2 targeted medicine.

“Ventana is a global leader in companion diagnostics. Our HER2 diagnostics portfolio, including both the VENTANA IHC and INFORM HER2 Dual ISH assays, is the market leader in terms of automation, medical value and customer adoption,” says Doug Ward, Vice President, Companion Diagnostics, Ventana Medical Systems, Inc. “We are working to enable the VENTANA HER2 (4B5) IHC companion diagnostic assay in all markets where Perjeta and Kadcyla are available for therapy, bringing this technology to physicians and patients worldwide.”

In addition to Roche, Ventana has worked with more than 45 bio-pharmaceutical partners over the past decade and is currently engaged in over 150 collaborative projects to develop and commercialize companion diagnostics globally.

For more than a decade, Herceptin (trastuzumab), a HER2-directed therapy, has been approved by health authorities for people with HER2-positive breast cancer. To further help build on the progress made with Herceptin, Roche has recently introduced two additional HER2-directed therapies, Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).

Perjeta® (pertuzumab) is approved for use in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy in people with HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic disease.

Kadcyla™ (ado-trastuzumab emtansine) is approved for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. People should either have already been treated for their metastatic cancer or have had their early-stage cancer come back during or within six months after they completed a course of treatment following surgery.

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.* Herceptin can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC®TH”
• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
• Alone after treatment with multiple other therapies, including an anthracycline-based therapy (a type of chemotherapy)
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age

Herceptin has two approved uses in metastatic breast cancer:

• Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
• Herceptin alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

For full details of important safety information regarding Perjeta and Kadcyla, please follow the company website link below to see the full original press release.

1The VENTANA HER2 (4B5) IHC assay is a CE-IVD companion diagnostic available outside the U.S. Check with your local representative for availability in your area. VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is not available or approved for use in the United States.

Epidemic of Escherichia coli infections traced to one strain of bacteria

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Fast-evolving lethal clone spreads worldwide, according to new study published today

FLAGSTAFF, Ariz., and WASHINGTON, D.C. — Dec. 17, 2013 — In the past decade, a single strain of Escherichia coli, or E. coli, has become the main cause of bacterial infections in women and the elderly by invading the bladder and kidneys, according to a study published today in the American Society for Microbiology’s open access journal mBio.

Besides becoming more resistant to antibiotics, the strain H30-Rx gained an unprecedented ability to spread from the urinary tract to the blood, leading to the most lethal form of bacterial infections — sepsis — and posing a looming threat to the more than 10 million Americans who annually suffer from urinary tract infections (UTIs).

This new study could help trace the evolutionary history of this superbug and possibly lead to the development of a vaccine, according to Lance B. Price, Ph.D., the study’s lead author.  Price is professor of environmental and occupational health at the George Washington University School of Public Health and Health Services (SPHHS), and is an associate professor in the Pathogen Genomics Division of the Translational Genomics Research Institute (TGen).

Previous research suggested that the ST131 group of E. coli – a family of many genetically related strains of bacteria — had independently gained resistance to antibiotics through separate genetic events. The ST131 group had been identified as a major source of superbugs — microbes resistant to multiple antibiotics — among UTI bacteria. If true, the existence of many different resilient strains would prove a formidable threat with multiple ways of evading the immune system and medical treatment, according to the new study.

Using advanced genomic techniques, Price and collaborators — James R. Johnson of the Veterans Affairs Medical Center and the University of Minnesota, and Evgeni V. Sokurenko of the University of Washington School of Medicine — discovered that the ST131 strains represented genetic clones abruptly evolved from a single strain of E. coli.

By gaining mutations in two genes, a strain called H30 gave rise more than a decade ago to the H30-R clone, which became fully resistant to the then-wonder-drug known as Cipro.  Soon after, a new clone evolved from H30-R called H30-Rx, which is resistant to several extended-spectrum antibiotics, such as third-generation cephalosporins.

Using whole-genome sequencing — spelling out, in order, each molecule of DNA — researchers analyzed the genomes of E. coli samples from patients and animals in five countries over 44 years, 1967-2011. They created a family tree tracing how the superbug clones emerged as the result of discrete genetic events.

“Astoundingly, we found that all of the resistance could be traced back to a single ancestor,” Price said. “Our research shows this superbug then took off, and now causes lots of drug-resistant infections.”

H30-Rx, appears to be much more adept than other E. coli at ascending from the bladder to the kidneys and then into the bloodstream, where it can be lethal, and the study suggests that H30-Rx may be responsible for 1.5 million UTIs and tens of thousands of deaths annually in the United States.

This study shows that, by focusing on H30-Rx, researchers might find a vaccine that could prevent many infections.  Vaccines for highly resistant strains of superbugs could protect people from ever getting sick in the first place, Price said.

“This strain of E. coli spreads from person to person and seems to be particularly virulent,” Johnson said. “This study might help us develop better tools to identify, stop or prevent its spread by finding better ways to block the transmission of the superbug, or by finding a diagnostic test that would help doctors identify such an infection early on — before it might have the chance to turn lethal.”

Sokurenko added, “We now know that we are dealing with a single enemy, and that by focusing on this strain we can have a substantial impact on this worldwide epidemic.”

The study, The epidemic of ESBL-producing Escherichia coli ST131 is driven by a single highly pathogenic subclone, H30-Rx, appears today in the peer-reviewed online-only scientific magazine mBio – the flagship journal of the American Society for Microbiology and the American Academy of Microbiology.

Ulthera’s Gregory Waller Named a Most Outstanding CFO by Phoenix Business Journal

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MESA, AZ– – Ulthera, Inc. — a global, high-growth medical device and specialty dermatology company with multiple aesthetic and medical applications — today announced that its Chief Financial Officer, Gregory Waller, was recognized as one of Phoenix’s “Most Outstanding CFOs” of 2013 by the Phoenix Business Journal.

Gregory Waller, CFO, Ulthera - 2Waller has been instrumental in helping the Company manage its growth over the past two years. Waller has also established Ulthera’s business analytics unit, restructured its international distribution agreements and helped to position the company for its next stage of expansion.

“Greg hit the ground running when he joined us in 2011,” said Matthew Likens, president and CEO of Ulthera. “His expertise in growth planning for both privately held and publically traded companies has allowed us to successfully meet the challenges of our growth profile while implementing procedures that improve the Company’s financial risk profile.”

“It’s an honor to be recognized by the Phoenix Business Journal and to be named among some of the most notable financial leaders in the country’s sixth largest city,” said Waller. “Ulthera has experienced much success, and its accomplishments are reflective of the talented people behind the company and the consistent efficacy associated with our signature cosmetic lifting procedure, non-invasive Ultherapy. The rapid adoption of Ulthera Systems worldwide is a signal that physicians are confident that the platform device will fuel growth in their practices.”

To date, more than 2,000 Ulthera Systems have been sold around the world and more than 250,000 Ultherapy treatments have been performed using it.

 

The “Most Outstanding CFO” recognition program was created by the Phoenix Business Journal to pay tribute to the evolving role of the CFO and recognize Phoenix-metropolitan leaders who exemplify the agility and prowess it takes to build and maintain the financial health of a successful company. Nominations were submitted by Phoenix-area business leaders, and the winners were selected by an advisory board that included local CFOs and CPAs, program sponsors, and Phoenix Business Journal staff.

About Ulthera
Ulthera, Inc. is a global, high-growth medical device and specialty dermatology company with multiple aesthetic and medical applications using its therapeutic ultrasound platform technology. The Ulthera® System is the first and only energy-based device to receive U.S. FDA clearance for a non-invasive aesthetic lift indication. It is used in a face and neck procedure known as Ultherapy®, which is cleared to lift skin above the brow, on the neck and under the chin. Founded in 2004 and based in Mesa, Ariz., Ulthera is a privately held company backed by top-tier venture capital firms, New Enterprise Associates and Apposite Capital. For more information, visit www.ultherapy.com.

Media Contact:
Lindsey Karberg
Ulthera, Inc.
480.336.1744 begin_of_the_skype_highlighting 480.336.1744 FREE  end_of_the_skype_highlighting
Email Contact

Read more: http://www.digitaljournal.com/pr/1642679#ixzz2nhGM7vOq

Medtronic Initiates Global Clinical Trial for Miniature Transcatheter Pacemaker System

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MINNEAPOLIS – December 9, 2013 – Continuing its leadership in advanced pacing technology and device miniaturization, Medtronic, Inc. (NYSE: MDT), today announced the first-in-human implant of the world’s smallest pacemaker: the Micra(TM) Transcatheter Pacing System (TPS). The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide.Continue reading→

Venture Madness – a new kind of startup battle – apply today

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Venture Madness – a new kind of startup battle – applications open today

Venture Madness, presented by Invest Southwest in partnership with Arizona Commerce Authority, is a competition where 64 startups from around the southwest will go head-to-head and compete for a portion of the $25,000 prize.

For the last 20 years, Invest Southwest, has been the premier capital conference in the region connecting investors with ventures and has had an “investment-centric focus” format, until this year. The event has gone through a serious transformation by responding to the needs of its audience and embracing the vibrancy of the startup community, starting with Venture Madness.

How Venture Madness works: Think of it as the “Battle of the Brackets” where startups duel it out bracket-style for the top slot. Thirty-two (of 64) bracket spots will be awarded to past participants from the Arizona Innovation Challenge (AIC); the remaining 32 spots will be filled through open enrollment. Startups from the southwest can apply today, December 6, 2013, through January 3, 2014.

Once the 64 ventures are established, there will be two online elimination rounds and 16 companies will advance to the live-demo rounds before a panel of judges on March 5-7, at Talking Stick Resort in Scottsdale.

Jonathan Ariano, chairman of Invest Southwest and Partner with Osborn Maledon, explains the new format and vibe, “Before, we used to have 12-14 companies go through a mentoring process to produce a ten minute presentation, with no Q&A, nor a contest-it was more of an investment-centric conference. When we went through the revamping process, we started thinking like a startup and asked ourselves ‘who is our customer?’ and spent months brainstorming on what that looked like. What we realized is that there are great programs and incubators that help entrepreneurs, but what was missing was the connective tissue…and that’s our job. We will be the connection to the investor community and showcasing what the Southwest has to offer-and the best way we can do that is Venture Madness.”

As part of the Venture Madness event, the organizers have weaved in more investor and startup connection opportunities including lunch-n-learns, cocktail parties and a Spring Training outing.

“We are really excited about this new format,” said Ariano. “There are a lot of great companies in the Southwest and the level of quality just keeps going up.”

Hey startups! Open enrollment starts now! Companies interested in participation must complete the online application, as well as create and submit a 90-second elevator pitch video. Applications and more information for Venture Madness, including detailed instructions, are available online at http://VentureMadness.com.

Venture Madness timeline:

  • December 6, 2013: Startup application opens
  • December 16, 2013: Event tickets available for purchase online
  • January 3, 2014: Startup applications close
  • February 3 – 14, 2014: First online elimination round with a 64 company bracket
  • February 17 – 24, 2014: Second online elimination round with a 32 company bracket
  • February 24, 2014: 16 companies to pitch live announced
  • March 5, 2014: Venture Madness 2014 kicks off with an evening cocktail reception at Talking Stick Resort
  • March 6, 2014: Third elimination round, 16 companies to pitch live
  • March 7, 2014: Elimination rounds four – six; Venture Madness Champion announced

Source:  http://aztechbeat.com/2013/12/venture-madness-new-kind-of-startup-battle-applications-open-today/

FedEx® Deep Frozen Shipping Solution now part of BIO Business Solutions

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BIO Business Solutions® has teamed up with FedEx to now include specialized deep frozen shipping solutions to member companies. The FedEx® Deep Frozen Shipping Solution provides innovative liquid nitrogen dry vapor technology via a cryogenic dewar along with end-to-end shipment monitoring and visibility. Specifically suited for preserving the integrity of biogenics, this solution provides up to 10 days of holding time at temperature ranges down to -150˚C. The solution offers member companies several advantages:

  • Keeps tissue samples and substances deep-frozen at -150°C
  • Provides up to 10 days without need for dry ice or power
  • Meets International Air Transport Association (IATA) requirements for both infectious substances (UN3373) and non-infectious clinical samples
  • Eliminates inventory of insulated boxes and dry ice
  • Provides advanced tracking and proactive monitoring via FedEx Priority AlertTM.
  • FedEx provides end-to-end solutions to help your temperature sensitive products maintain optimum temperature while in transit across the nation or across the ocean.

Member Benefits

Discounted Flat Fee of $435 for Domestic or $750 for international shipment

Enrollment

To enroll in the FedEx® Deep Frozen Shipping Solution, click below:

More Information

For more information on FedEx® Deep Frozen Shipping Solution, call 1-888-370-3971

FedEx® Deep Frozen Shipping Solution Case Study

Read the case study below to learn how Cenetron Diagnostics was successful using the FedEx® Deep Frozen Shipping Solution to cost effectively transport and track temperature sensitive clinical trial shipments and to learn how businesses like yours are taking advantage of powerful integration solutions with FedEx. As a reminder, FedEx Web Services allows you to integrate FedEx® shipping, tracking, rating, address validation, reporting tools, and more, directly into your website.

Read more here: Cenetron_Case_Study.pdf

Eligible Affiliates

All AZBio and BIO members are eligible to utilize the BIO Business Solutions® program with FedEx.