BB&T Staff Writer and Staff Reports

Ovarian cancer is a stealthy disease, hiding behind a cadre of non-specific symptoms. The ninth most common cancer in women, it ranks as the fifth leading cause of cancer death in women. Abbott (Abbott Park, Illinois) has submitted an application for FDA approval of a new diagnostic tool that can be used to monitor patients for the most common form of ovarian cancer.

The Architect HE4 assay uses a simple blood test to monitor for the recurrence or progression of epithelial ovarian cancer. If approved, this important immunoassay would be the first automated HE4 test available in the U.S.

“The Architect HE4 assay is a two-step immunoassay for the detection of the HE4 antigen in human serum,“ Beth Schodin, PhD, manager of Global Scientific Affairs at Abbott, said. “The test uses chemiluminescent technology and measures the Relative Light Units (RLUs) of the reaction in the sample. A direct relationship occurs between the amount of HE4 antigen in the sample and the RLUs detected by the Architect instrument.“

A 2003 study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker and is considered the best single marker for stage 1 of the disease.

According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46%. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93%. Less than 20% of all ovarian cancer is found in the early stage.

“The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The Architect HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease,“ said Michael Warmuth, senior VP of diagnostics at Abbott.

Fujirebio Diagnostics (Malvern, Pennsylvania) and Abbott are working under a license agreement to develop this new ovarian cancer marker for use on Abbott's automated Architect diagnostic analyzers.

A manual form of the HE4 test has been approved by the FDA as an aid in monitoring recurrence or progressive disease in patients with EOC and is CE marked for use within the European Union as a diagnostic test. The indication in the U.S. will be different – as a monitor of disease progression or recurrence.

“Upon approval, the Architect HE4 assay is to be used as an aid in the monitoring of ovarian cancer, in conjunction with other clinical methods, such as biopsy or any imagining testing used for monitoring for cancer,“ Schodin said.

The current gold standard for monitoring ovarian cancer is a test that measures for elevated levels of the CA-125 substance in the blood. According to Fujirebio, that test can be limited in detecting all types of ovarian cancer, prompting researchers to seek out additional biomarkers that offer higher sensitivity and can be indicative of the disease to complement CA-125.

But women with elevated levels of HE4 in their blood may be more likely to have ovarian cancer, according to results of a prospective study published in Gynecologic Oncology and sponsored by Fujirebio.

In the study, Moore's team evaluated nine potential biomarkers in 259 patients with pelvic mass. Researchers measured levels of each biomarker within the women's blood and then compared the results with biopsies of their tumors. With 72.9% sensitivity and 95% specificity, HE4 was the most effective biomarker for detecting ovarian cancer. When CA-125 was added, the result was an even more powerful combination of tests with sensitivity for detecting the disease increased to 76.4%, the company said.

Elsewhere in the product pipeline:

• Allergan (Irvine, California) reported FDA approval of Juvéderm XC, a new formulation of the Juvéderm dermal filler and what Allergan calls the latest advancement in hyaluronic acid (HA) dermal fillers. The new formulation contains the local anesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or parentheses) that appear around the nose and mouth. Juvéderm is the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment and number-one selling hyaluronic acid dermal filler, the company said.

• Aragon Surgical (Palo Alto, California) reported FDA clearance for Lektrafuse Telo, the newest addition to its Lektrafuse platform. The expansion of the Lektrafuse Platform of radio frequency (RF) based tissue sealing and cutting instruments allows surgeons to use the advantages of the Lektrafuse platform in a broader range of applications. The platform consists of the Lektrafuse RF Generator to be used in conjunction with the Lektrafuse Caiman, for laparoscopic surgical procedures, and now the Lektrafuse Teleo, both cleared for sealing vessels up to and including 7 mm in diameter. Teleo has a shorter shaft than it predecessor and is therefore ideal for open and minimally invasive procedures where a long shaft is not needed. Aragon claims the jaw mechanism of these instruments is uniquely engineered with a floating hinge to create durable seals. It precisely grasps the targeted tissue and delivers strong, uniform compression force across the entire electrode surface, from the tip of the jaw to the base, to create optimal conditions for sealing. Compression force in other instruments declines significantly from the proximal to the distal end of the tip, pushing tissue out of the jaws and providing little to no force to tissue near the tip.

• Biomagnetics Diagnostics (San Francisco) said that the company is initiating several clinical trials in multiple markets, including Kenya and India, and is also in talks with one of the largest hospitals within the social security system of Mexico in order to address the clinical requirements of that market. Through governmental agencies and blood banks in Kenya and India, Biomagnetics Diagnostics will have access to malaria (as well as other infectious diseases) infected blood that can be used to develop immunoassays and perform clinical trials on the company's integrated optical sensor in a cost effective, rapid manner. “We are very excited to begin clinical trials of the company's IOBS platform,“ said Clayton Hardman, CEO of Biomagnetics Diagnostics. The IOBS platform is a relatively new classification of pathogen detection equipment that uses advanced fiber optic-based technology to detect a wide variety of human and animal pathogens. These devices produced by the company are specifically designed to be field deployable, ultraportable and very easy to use, allowing for extremely rapid detection of various viral and bacterial pathogens by relatively untrained personnel outside of the laboratory setting.

• CoActiv Medical (Ridgefield, Connecticut) has introduced EXAM-PACS touch screen image viewing for the Apple iPad large-screen digital viewing and communications device. CoActive says this is based on the existing EXAM-PACS iPhone image viewing system, and the new iPad system will support bi-directional data communication between a PACS and any iPad using the new device's built-in WiFi capabilities. This version of EXAM-PACS for iPad will also be fully compatible with the Apple iPad 3G model scheduled for release in April. CoActiv EXAM-PACS iPad support enables secure DICOM Query/Retrieve functionality and also allows files to be pushed directly to the device over WiFi and 3G connections. Once images arrive on the mobile device, they may be viewed using the full range of iPad's Touch Screen capabilities, including scroll, pan, zoom and window & level and measurement functions.

• ConforMIS (Burlington, Massachusetts) said that Leisure Yu, MD, an orthopedic surgeon at Loma Linda University Medical Center in California, is performing surgery with the iUni and iDuo, the company's personalized unicompartmental and bicompartmental knee resurfacing implants. The implants are designed as a bone-sparing alternative to traditional total knee replacement in patients whose arthritic damage is limited to just one or two compartments of the knee. The implants resurface only the affected areas, preserving far more bone on both the femur and tibia than traditional total knee replacement surgery. It also preserves the patient's ligaments, helping to maintain a more natural feeling knee, and it safeguards options for future surgical procedures. The implants are made using a computer modeling system and software to extract individual and atomic information from CT or MR images.

• Life Spine (Hoffman Estates, Illinois) reported FDA clearance to both the Dyna-Link Spinal System and the Presidio Spinal Plating System. The Dyna-Link system features a stand-alone device that accommodates both fixed and variable angle screws. The Presidio system is a thoracolumbar plating system that features multiple types of low-profile implants. Both offerings incorporate an innovative, zero-step locking mechanism and use comprehensive instrumentation designed to reduce surgical steps and intra-operative complexity.

• Mesynthes (Wellington, New Zealand) was granted FDA clearance for the company's Endoform Dermal Template. Endoform, an extracellular matrix biomaterial, provides a biologic template for tissue regeneration. The extracellular matrix contains a complex mixture of important biological molecules, including structural and adhesive proteins, such as collagens, elastin, fibronectin and laminin, and glycosaminoglycans. Endoform Dermal Template is presented as a sterile dry sheet in a peel pouch and is strong and easy to handle in a dry or wet state. It is applied directly to the wound bed, then rehydrated, covered with a non-adherent dressing, and secured in place.

• Pall (Port Washington, New York) has introduced the PallSep Biotech system for the gentle separation of target molecules from complex biotechnology process fluids. The new system uses vibrating membrane filtration (VMF) technology and encapsulated hydrophilic polyethersulfone membrane filter modules. This unique combination reduces the accumulation of retained species on the membrane surface which allows for increased transmission of the target molecule. The VMF principle is based on the rapid oscillation of porous membrane plates within a process feed stream to create shear at the membrane surface. The generated shear forces are limited to a narrow portion of the flow channel, reducing the amount of process fluid exposed to the shear.

• Palomar Medical Technologies (Burlington, Massachusetts) said that the Lux1540 Fractional non-ablative laser handpiece has received FDA clearence for the treatment of striae (stretch marks) using a fractional laser. This new clearance expands the range of treatments offered by the Lux1540, which may be used to treat surgical scars, acne scars, and melasma, as well as offer non-ablative skin resurfacing. In support of this new clearance, Palomar in conjunction with Body1.com has released a consumer education site, Stretchmarks1.com, to help consumers understand more about treatment options and locate providers of Palomar's Lux1540 technology for stretch marks.

• Polymedco (Cortland Manor, New York) was granted FDA clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis. The system measures 280 FIT samples per hour and ensures that quality data is consistently collected. Indicated for use in routine physical examinations, the test measures the presence of human hemoglobin in a patient's stool. The results assist physicians in recommending patients to colonoscopy, leading to the detection and treatment of colorectal cancer at an earlier stage.