SensiGen offers new program to researchers

SensiGen (Ann Arbor, Michigan) a privately held biotechnology company focused on developing gene-based molecular diagnostic tests said it had a new program to make the company's AttoSense HPV assay available to head and neck cancer researchers worldwide after recent studies showed that the success or failure of various treatment options (chemotherapy, radiation, extensive surgery) are largely determined by the viral load of human papillomavirus (HPV) in tissue samples from patients.

These studies, carried out by the head and neck oncology team at the University of Michigan (also Ann Arbor) and published in the Journal of Clinical Oncology, demonstrate that head and neck cancer patients with higher concentrations of HPV, a virus long known to be associated with head and neck cancer, cervical cancer, and others, are much more likely to respond to organ-sparing chemotherapy than patients without high concentrations of the virus. This finding could offer significant hope for thousands of head and neck cancer patients facing uncertain and unpleasant treatments.

"The data clearly show the importance of quantitative HPV testing in patients diagnosed with head and neck cancer," said Thomas Carey, leader of the University of Michigan team that reported the breakthrough results this summer. "With the AttoSense HPV test and other biomarkers, we may soon be able to pinpoint the right therapy for each patient and maximize the chance of success on the first try, thus reducing the number of people who must endure multiple costly and uncomfortable treatments."

SpectaSciences gives WavSTAT to study

SpectraScience (San Diego) said that it is shipping its WavSTAT optical biopsy system to the Mayo Clinic and to the University of California San Diego/VA to complete a study at each site. The purpose of this study is to demonstrate the clinical value of the Optical Biopsy System as an adjunctive tool to improve an endoscopists' clinical sensitivity in identifying dysplasia or cancer in the esophagus. This will be the final phase of the study which has been conducted over the past three years.

The WavSTAT Optical Biopsy System was approved by the FDA in November 2000 as safe and effective for adjunctive use during endoscopy of the colon to improve the endoscopist's clinical sensitivity to identify pre-cancerous polyps. The system received the CE mark in Europe in September 2007. The approved WavSTAT System uses a low-power, non-significant-risk laser to scan tissue and instantaneously help the physician determine whether small polyps are normal or pre-cancerous without physically removing the tissue. If they are pre-cancerous, they are removed during the same procedure.

RMI receives ISO certification

Rochester Medical Implants (RMI; Rochester, Indiana) a contract manufacturer of high-precision spinal and orthopaedic implants and instruments, reported that it has achieved ISO 13485:2003 certification through auditor NSF International.

"Building upon our existing ISO 9001:2000 quality system, the ISO 13485:2003 certification process has been a major business initiative of our company and reflects the organization's commitment to manufacturing high-quality products for the medical device market," said President James Evans.