A Medical Device Daily

Grant Life Sciences (Los Angeles), reported that it has decided to terminate further negotiations with Diagnostic Technologies (DTL, Yoqneam, Israel) related to Grant’s serum-based cervical cancer diagnostic technology (U.S. Patent No. 6,743,593) as reported in April 2006, and subsequently extended on Oct. 15, 2006. An extension of the Memo of Understanding (MOU) between Grant and DTL was made necessary because DTL’s business activities were significantly hindered as a result of the 2006 Israel/Lebanon conflict, which occurred between July 12 and Aug. 14, 2006.

“We will continue to develop our serum-based test for cervical cancer while seeking an appropriate development-and-commercialization partner,” said Hun-Chi Lin, PhD, Grant’s president and chief scientist. “Nevertheless, we are very pleased with the near-term opportunity afforded us by our relationship with Alphagenics and its DNA-based HPV test for cervical cancer.”

On June 13, 2007, Grant said that it had signed a MOU with Alphagenics Diaco Biotechnologies (Trieste, Italy) to exclusively in-license the manufacturing and marketing rights to Alphagenics’ molecular diagnostic test for Human Papilloma Viruses (HPVs) in Greater China and the U.S. and non-exclusively in Europe, India, Australia and Japan. The Alphagenics HPV test is a DNA-based diagnostic that uses standard molecular diagnostic equipment found in most commercial laboratories.

Alphagenics’ HPV DNA test complements the HPV blood test that Grant Life Sciences is developing—a serum-based immunological test to detect cervical dysplasia. The majority of cervical cancer is caused by HPVs. Of the more-than-100 types of HPV approximately 10 have been linked to cervical cancer. While a serum-based test to detect precancerous evidence and cancer of the cervix is still viewed by Grant as the preferred test-methodology to address the needs of the developing world, molecular (DNA) testing is currently the approved test protocol in both the U.S. and Europe.

“Our introduction of the Alphagenics HPV test would not only allow commercial laboratories to provide molecular testing but also would complement the current introduction of vaccines against HPVs,” said Lin. “The current approved vaccine in the U.S. provides for inoculation against four types of HPV for use in girls and women 9-to-26 years of age, who presumably have not been exposed to the viruses. However, women who have reached sexual maturity and have not been exposed to one of the four HPV-types may benefit from the vaccination, according to the Advisory Committee on Immunization Practices (ACIP). Consequently, the Alphagenics test can be used by the balance of the female population to determine exposure and the possible use of the vaccine if found negative. Further both vaccines on the market (GSK’s vaccine is approved for Australia for ages 10-to-45 and Merck’s vaccine is approved in the U.S. for ages 9-to-26) only confer protection against HPV oncogenic types 16 and 18. While these types are predominant (approximately 60+ %) in the Caucasian market, they are not the dominant types found in the Asian, African, Indian, and Hispanic populations. Fortunately, the Alphagenics test is designed to test for all the serotypes of oncogenic HPV.”

In addition, Lin said that the Alphagenics test can be used in the current gynecological regimen to help qualify Pap test results in the case of ambiguous readings, at a cost less than the current approved molecular test. Grant expects to launch the Alphagenics HPV DNA-based test in the Asian and Indian markets during the fourth quarter of this year.

Grant Life, a development stage company, makes diagnostic kits for the screening, monitoring, and diagnosis of diseases with emphasis on women’s health, infectious diseases, and cancers.

In other agreement news:

• VeriChip (Delray Beach, Florida) reported that its wholly owned subsidiary, Xmark (Ottawa, Ontario) has entered into a teaming agreement with Ekahau, (Saratoga, California) a provider of Wi-Fi-based Real Time Location Systems (RTLS). The two companies have agreed to collaborate on wireless solutions in the healthcare market to best meet customers’ needs.

The agreement covers Xmark’s RFID-based healthcare security systems and Ekahau’s Wi-Fi-enabled RTLS. Specifically, the companies will collaborate on providing solutions around asset tracking, infant protection, patient safety and theft prevention in the healthcare industry. Solutions such as wander prevention, perimeter security and campus to bed-level tracking of assets are initial areas of focus for the collaboration. The two companies are also cooperating on an integrated solution that combines RFID and Wi-Fi technologies to suit the particular needs of certain customers.

• XCPT (Venice, Florida), has entered into a representation agreement with Lifecore Biomedical (Chaska, Minnesota) to market its products to dentists throughout the world.

XCPT’s software is a graphic, face-to-face, patient consultation and engagement method recognizing the importance of visual learning during treatment planning. With XCPT, the patient is involved in every step of the dental treatment process as the clinician uses the patient’s own X-rays, CT scans and/or photographs to communicate treatment options and solutions.

The agreement with Lifecore marks the third dental implant company and seventh company overall which has begun to incorporate XCPT as a practice-building tool throughout their salesforce.

Lifecore develops implantable biomaterials and medical and surgical devices for applications in the fields of dentistry, gynecology, ophthalmology, drug delivery, veterinary and wound care management.