New Noninvasive Meter

New Noninvasive Meter

NEW NONINVASIVE METER

Technical Chemicals & Products, Inc. (TCPI),

a Florida-based maker of diagnostic testing and health screening products, has begun final

clinical trials of its new "TD Glucose" noninvasive glucose monitor. External

studies and preliminary clinicals "have shown efficacy and substantial correlation

(98%+) of the TD Glucose System with current finger-stick glucose tests," say company

documents.

A "noninvasive" glucose meter, the TD

Glucose System does not require the user to pierce the skin with a lancet, or in any way

draw a blood sample. The user places a small, chemically-treated patch on the forearm for

about five minutes, then the meter is held up to the patch (no wires to plug in), which it

optically scans, providing an immediate reading. The single-use patch is then removed and

discarded.

Although not yet free of the need to

"individually calibrate" meter to patient, TCPI states they have reduced the

interval to once every six months, and that it may be further reduced. The calibration is

meant to be performed by the patient's physician, and is described as "similar to a

glucose tolerance test." Once the test is completed, the physician enters the results

into his computer; company software then updates the patient's meter.

The unique part of the system is the patch; the

meter is very simple, and is scheduled to sell for about $100. Where the meter is unique

is in its optical scanning system (no wires), its 32-bit operating chip (like a Pentium

computer), and its provision for 720-test memory (90 days x 6 tests per day). The meter is

meant to be pocketable. It has proven durable, and it uses a 9-volt transistor battery,

available anywhere.

The company states their proprietary

glucose-sensing patch has already been found to be "in no way a biohazard;" no

specialized disposal techniques or procedures will be required. As no lancets are needed

either, look for a real reduction in dangerous waste.

As required by the calibration procedures

described above, the meter has a data-port for attaching to a computer. The patient will

be able to download test data as well. Not only may this data-port allow future use of a

voice synthesizer, the company has expressed interest in possibly including an onboard

voice chip in a "second generation" of the meter.

TCPI, which will manufacture both meter and

disposable patches, will supply them to its "marketing partners," who will

handle distribution, publicity, and sales (and will have final authority over pricing).

Dai-Ichi Co., Ltd., of Japan, will handle Asian sales; American "partnership"

negotiations are pending.

The company intends to submit its test findings

to the FDA in late 1999. Stay tuned.