A Diagnostics & Imaging Week

Chembio Diagnostics (Medford, New York) reported signing a Cooperative Research and Development Agreement (CRADA) with the Centers for Disease Control and Prevention (Atlanta) to develop a rapid combination test for Syphilis utilizing Chembio's Dual Path Platform (DPP) technology and the CDC's patented Syphilis antigens.

The test will be designed to detect both treponemal and nontreponemal antibodies in the same device and therefore could potentially be both a screening and confirmatory test in a point-of-care setting.

Scientists from Chembio and CDC will collaborate to develop the test. After successful completion of device design and analyses of data, initiation of field studies and data collection will proceed in accordance with the FDA and World Health Organization (WHO; Geneva) requirements. CDC will be responsible, among other matters, for undertaking testing procedures and clinical trials. Chembio will provide capacity for producing prototype devices and submitting regulatory documents to the FDA.

"This agreement enables us to simultaneously broaden our rapid test products beyond our core areas of HIV, Chagas Disease and Tuberculosis, capitalize on our DPP intellectual property, and collaborate with the leading public health organization in the U.S. that has expertise in sexually transmitted diseases such as Syphilis," said Lawrence Siebert, president/CEO of Chembio.

The DPP technology is a point-of-care test platform, which, based on internal tests, "can overcome the sensitivity and specificity issues related to conventional lateral flow technology," Chembio said.

In other agreements:

• Ciphergen Biosystems (Fremont, California) and Ohio State University Research Foundation (OSURF; Columbus, Ohio) reported they have entered a collaborative agreement to develop and clinically validate a diagnostic test to detect thrombotic thrombocytopenic purpura (TTP), a hematologic disease. Financial terms of the agreement were not disclosed.

TTP is a blood disorder characterized by low platelets, low red blood cell count (caused by premature breakdown of the cells), neurological abnormalities and sometimes abnormalities in kidney function. In most cases, this disease is caused by a deficiency in or auto-antibodies to an enzyme called ADAMTS13, which cleaves von Willebrand Factor. Loss of this enzyme causes platelet clumping and red blood cell destruction that are the hallmarks of TTP.

"A clinical diagnostic test that can rapidly detect deficiencies in the enzyme activity associated with TTP will help physicians more effectively manage this devastating disease," said Haifeng Wu, MD, assistant professor of pathology and medicine and director of clinical coagulation laboratory at Ohio State University Medical Center. "This test will help physicians determine when to initiate plasma exchange and monitor response to this therapy."

Annual testing opportunities exist to diagnose patients with TTP; evaluate patient responses to therapy; and monitor patients during clinical remission to prevent recurrences of the disease.

"Current testing methods to diagnose TTP lack this quantitation and ease of use," said Eric Fung, MD, PhD, chief scientific officer for Ciphergen.

OSURF and Ciphergen will optimize the assay to measure enzyme and antibody inhibition activity and will jointly conduct multi-center studies to validate the test.

• Franklin & Seidelmann Subspecialty Radiology (F&S; Cleveland) reported the extension of its service offering as a result of its new partnership with Apex Radiology (Coral Springs, Florida), a provider of teleradiology services.

F&S said the agreement enables it to meet the demands of its imaging center, hospital, and radiology group clients by providing subspecialty expertise through the F&S network and general radiology interpretations through Apex. Apex will provide general and nighttime radiology interpretations from modalities such as X-ray, ultrasound, and CT for some of its clients. Additionally, F&S will provide subspecialty expertise for some Apex radiology clients.

Scott Seidelmann, president and chief operating officer of F&S, said the company can now provide general radiology services without taking our focus off of what it does best — subspecialty radiology.

In order to distribute images and reports between the two companies' teleradiology platforms, system integration will be completed by Jan. 1.

Apex is a teleradiology solutions provider serving the rural, urban and suburban areas of the U.S.

• Nuance Communications (Burlington, Massachusetts), a provider of speech and imaging solutions, and Vocada (Dallas), a developer of technology-based solutions for critical test result management (CTRM), reported an agreement to integrate their products to create a simplified user interface for radiologists and pathologists to quickly and accurately communicate critical patient findings and report test results.

Using Vocada's Veriphy system with Dictaphone PowerScribe from Nuance eliminates delays and inaccuracies in the communication of critical results, improving patient safety and streamlining reporting, the companies said.

Vocada's Veriphy will become a component in the Dictaphone PowerScribe dashboard and the two systems will share the same physician directories and database.

Using the Veriphy system with Dictaphone PowerScribe, a reporting clinician creates a voice message directly within PowerScribe which is then automatically passed to the Veriphy system. Instant notifications are then sent to the ordering clinician via pager, cell phone, fax, and e-mail. This automated process is designed to saves valuable time and ultimately improve patient safety by ensuring that critical test results are delivered quickly and accurately.

• Fujifilm (Tokyo), a provider of medical imaging equipment, and Zonare Medical Systems (Mountain View, California), a developer of next generation ultrasound technology, have enetered an OEM agreement.

Fujifilm will market Zonare's z.one ultrasound system, based on revolutionary Zone Sonography technology, under the Fujifilm brand Fazone M throughout Japan, one of the world's leading ultrasound markets.

Both companies will also investigate potential co-operative development of future imaging modalities including incorporation of certain Fujifilm technology into Zonare products and Zonare technologies into Fujifilm products.