A Diagnostics & Imaging Week

AMDL (Tustin, California) reported signing Precision Diagnostic Laboratory (PDL; New Holland, Pennsylvania) as its first customer to offer the AMDL DR-70 (FDP) in vitro cancer test to patients and doctors in the U.S.

AMDL said it expects to expand product distribution and sales to at least 10 worldwide markets for up to $5 million in DR-70 sales in FY09.

In other agreements and contracts news:

• BD (Becton, Dickinson; Franklin Lakes, New Jersey) and Fujirebio Diagnostics reported the signing of a worldwide development and supply agreement for oncology diagnostic assays.

Under the agreement, the two companies will develop diagnostic products that incorporate Fujirebio Diagnostics' cancer biomarkers for use on BD's multiplex testing platform. The initial products will be directed to the ovarian cancer biomarker, HE4, which is FDA-cleared for monitoring the progression or recurrence of epithelial ovarian cancer. Fujirebio Diagnostics also grants BD, through its BD Diagnostics TriPath platform, access to its other cancer biomarkers for inclusion in future multiplex diagnostic products.

• PGxHealth, a division of Clinical Data (Newton, Massachusetts), said that it has begun a broad research collaboration with the University of Pittsburgh to discover and further validate the application of genetic variants in FCGR (Fc gamma receptor) genes, including FCGR3A, for predicting response to monoclonal antibodies (mAbs) in cancer treatment. The strategic collaboration aims to conduct a series of clinical programs to evaluate the response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab) and Herceptin (trastuzumab) and potentially other mAbs of the IgG1 subclass in treating a variety of cancers.

• Bio-Matrix Scientific Group (BMSN; San Diego) and Entest BioMedical, BMSN's wholly-owned subsidiary, reported that a contract has been signed with Brian Koos, a professor of obstetrics and gynecology at the David Geffen School of Medicine at University of California, Los Angeles, for the development and validation of a screening test for gestational diabetes, a glucose intolerance in pregnant women.

Koos is the developer of the test which is licensed to Entest by UCLA.

Entest is the exclusive licensee for the test, billed as able to mitigate the lengthy process of diagnosing gestational diabetes. The companies said that their goal is to develop a large scale sampling for validation of the screening test with FDA, for marketing to hospitals and medical clinics.

• Siemens Healthcare (Deerfield, Illinois) said it has donated laboratory instruments and diagnostic tests to the Kidney Early Evaluation community outreach program of the National Kidney Foundation's (New York) to help reduce the number of individuals that develop chronic kidney disease.

The program raises awareness in the U.S. about early detection of kidney disease and screens, at no charge, high-risk individuals.