A Medical Device Daily

Inverness Medical Innovations (Waltham, Massachusetts), Chembio Diagnostics (Medford, New York) and StatSure Diagnostic Systems (SDS; Framingham, Massachusetts) yesterday rolled out details of an agreement providing Inverness with exclusive worldwide marketing rights to Chembio's FDA-cleared, point-of-care, rapid test for the detection of antibodies to HIV.

The test uses Inverness' lateral flow technology as well as SDS's patented "barrel" technology designed to maximize ease-of-use and minimize exposure to infectious agents.

Inverness obtains exclusive U.S. marketing rights to Chembio's proprietary lateral flow cassette test (HIV 1/2 Stat Pak) for antibodies to HIV, which will complement Inverness' Determine rapid HIV test (sold only outside the U.S.). Chembio and SDS also have settled litigation between them and will equally share in the profits relating to the application of the barrel technology (see "Court report," p. 2).

Both Chembio HIV tests are FDA-cleared for use with fingertip blood, whole blood, serum or plasma for the detection of HIV-I as well as HIV-II antibodies. The barrel format is intended to provide convenience, safety and superior product performance, the company says. Both tests achieved a sensitivity of 99.7% and a specificity of 99.9% in clinical trials.

Inverness also has granted Chembio a license to its lateral flow technology to manufacture and market the Chembio cassette HIV product and a Chembio dipstick HIV test outside the U.S. and to manufacture and market certain defined veterinary and emerging disease tests. Inverness will also receive non-exclusive worldwide marketing rights under Inverness brands to this latter group of products and has invested $2 million in a Chembio financing as announced separately today. In addition, Inverness will also grant to SDS a license to its lateral flow technology for an HIV cassette product as well as certain other products.

Ron Zwanziger, CEO of Inverness, said, "The recently published revised HIV testing recommendations from the CDC point to the need for screening all adults aged 13 to 64 as well as for routine testing for pregnant women and persons at high risk of infection."

Lawrence Siebert, president of Chembio, said, "This is a significant milestone for our company as we believe Inverness will be able to achieve widespread distribution of our products."

Steve Peltzman, CEO of SDS, said, "Great technology, when married to outstanding manufacturing and Inverness' marketing, can produce extraordinary results."

In other agreements:

• Roche Diagnostics (Indianapolis) said it intends to negotiate an agreement for the joint development/commercialization of homogeneous, automated oral fluid drugs-of-abuse assays that can run on random access chemistry analyzers with OraSure Technologies (Bethlehem, Pennsylvania).

The oral fluid assays will be used with OraSure's Intercept oral specimen collection device and Roche's kinetic interaction of microparticles in solution (KIMS) technology. They will be designed to run on various automated analyzers and to allow oral fluid samples to be processed with the efficiency of current urine-based tests. Among the potential benefits to laboratories will be increased efficiencies and quicker turnaround times, the companies said.

The Intercept device, OraSure says, is the only FDA-cleared in vitro diagnostic, laboratory-based oral fluid system used for detecting drugs such as marijuana, cocaine, opiates, PCP and amphetamines, barbiturates, methadone and benzodiazepines. Intercept testing is used in workplace, drug treatment, and criminal justice markets, as well as in public schools.

• llumina (San Diego) said that the Center for Human Genetics (CHG) at Duke University (Durham, North Carolina) has selected the Infinium HumanHap550 BeadChip for an Autism study of over 1,800 individuals and their families.

Margaret Pericak-Vance and John Gilbert will lead the Duke CHG team of autism researchers.

Pericak-Vance said, "Multiple genes and the interactions of these genes contribute to diseases like autism, making their identification very difficult.

Illumina develops and markets tools for large-scale analysis of genetic variation and function. The company says its BeadArray technology provides the throughput, cost-effectiveness, and flexibility necessary to enable researchers in the life sciences and pharmaceutical industries to perform the billions of tests necessary to extract medically valuable information from advances in genomics and proteomics.

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