A Medical Device Daily

Inverness Medical Innovations (IMI; Waltham, Massachusetts) is wasting little time this year establishing its commitment to the point-of-care (POC) diagnostics market. The company reported yesterday that it has developed a POC testing platform, the pima analyzer, perhaps reaffirming the stance it took during the RBC Capital Markets Healthcare Conference in New York to expand in the POC market (Medical Device Daily, Dec. 16, 2008).

During that conference, Jon Russell, VP of finance for IMI, noted that, while it is built on a foundation of serving the professional diagnostics segment, the company "always has been ultimately pointed at the home."

That looks to be the case, as the instrument is said to be easy to use and quite accessible. The company also said the device is a first-of-its-kind CD4 cell enumeration test.

Clinical trials began in 4Q08 and the instrument with CD4 application will be launched to select markets in mid-2009.

It is geared toward those who already have been tested as HIV-positive. CD4 testing is a critical baseline measurement to gauge the state of an HIV infected person's immune system and for clinicians to initiate antiretroviral (ART) HIV therapy.

Inverness featured the product at the 15th annual conference on AIDS and STIs in Dakar, Senegal, in early December.

CD4 tests measure the number of T cells containing the CD4 receptor. Results are usually expressed in the number of cells per milliliter of blood. While CD4 tests are not an HIV test in that they do not check the presence of viral DNA, or specific antibodies, they are used to assess the immune system of patients.

Patients often undergo treatments when the CD4 count reaches a low point, around 200 cells per milliliter. Medical professionals also refer to CD4 tests to determine the efficacy of the treatment.

Measurement of CD4 levels indicates how far the disease has advanced and the risk to the patient of complications or debilitating infections. In addition to the baseline measurement, CD4 is also measured generally two to four times annually during the course of HIV therapy.

The device is a portable system with a rechargeable battery and provides rapid results. Using a small fingerstick blood sample, the platform will be able to deliver not only CD4 cell enumeration but ultimately allow analysis of a wide array of additional markers.

It boasts:

• CD4 count in 20 minutes.

• Battery powered.

• Portable & robust.

• " Walk Away" testing.

• Embedded software.

• No external calibration.

• On-board data archive.

Inverness President/CEO Ron Zwanziger said, "We are very pleased with the interest generated from the presentation of the pima instrument and the CD4 assay at the important conference in Dakar and recognize the significant impact it will have upon the care of those living with HIV and AIDS in the developing world where few technologies are available at point-of-care. We anticipate broad possibilities for application of the instrument across our disease management portfolio."

The Inverness CD4 system's design is optimal for use both in point-of-care settings in the developing world as well as in the physician's office in the developed world.

The device is being touted as revolutionary simply because of its ease of use and because it is very accessible. The device enters a market where it is estimated that there are more than 33 million people living with HIV/AIDS globally, 90% of which reside in the developing world.

Of the nearly 30 million infected individuals in the developing world, less than 20% are aware of their HIV status. Further, it is estimated that less than 1/3 of those confirmed as being infected in the developing world have access to CD4 testing.

According to the company, the introduction of pima CD4 represents a "significant step forward" in realizing effective integration of testing, care and therapy at the point-of-care setting, where the need is greatest.

Inverness is one of the largest players in the diagnostics space, growing from start-up status in late 2001 and soaring to a $1.7 billion med-tech giant in 4Q08.