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.