COVER STORY

HEALTH BEGINS
AT HOME
Armed with a plethora of OTC test kits, consumers are taking
do-it-yourself health screenings to new heights

Sandra Levy arena, Sciona Inc. is already marketing the Cellf Com-
prehensive Test, a kit that analyzes 19 genes that may

A
man nervously has a blood sample drawn to play an important role in how a person’s body manages
find out whether he has contracted hepatitis B. bone health, heart health, antioxidants and detoxifica-
Another man is about to find out his sperm tion, insulin resistance, and inflammation. Consumers
count. Meanwhile, a woman is waiting to find out what use a special stick to swab the inside of their cheek and
stage of menopause she is in. These tests aren’t being then send the sample with a questionnaire to Sciona’s
performed in physicians’ offices. They are being con- laboratories. Consumers receive a Cellf Assessment
ducted by patients in the privacy of their homes. with health recommendations.
With patients increasingly taking a hands-on role in Not to be outdone, San Francisco-based DNA Direct
their health and well-being, it’s no wonder a growing offers consumers an array of genetic tests, including
roster of home diagnostic tests is being produced by tests for cancer, infertility, blood clots, chronic lung/liv-
manufacturers. And these tests, which use new technol- er disease, and hereditary iron overload. The company
ogy, are becoming more convenient and comfortable as pairs each test result with a personalized interpretation.
well as faster and easier to use. Manufacturers are also beginning to churn out
The list of conditions that patients can devices that test for more than one con-
now test at home has expanded dition or perform double func-
to include asthma, tions. Patients can also
high cholesterol, now test their blood
colorectal disease, al- glucose and blood
lergies, urinary tract in- pressure with one de-
fections, ovulation, preg- vice. Duo-Care is mak-
nancy, and male fertility. ing its debut from
There are even tests for GenExel-Sein Inc. Duo-
breast and colorectal Care combines a home-
cancer; menopause; ane- use blood glucose moni-
mia; vaginal, bladder, tor and a wrist blood
and ear infections; pressure monitor. The
prostate health; thyroid; device provides technol-
and birth defects. There ogy through the use of
are also monitors that as- Fast Tracking Tempera-
sess body fat and eye ture technology and
pressure and screen for Advanced Oscillometric
irregular heartbeat. Algorithm. The firm
It looks like gene- claims that this technol-
based tests and devices ogy allows for accurate
that test for more than blood pressure meas-
one condition at a time ures for patients with
Photo: Jim Shive

will be the wave of the normal circulation and

future. for those with arterio-
In the gene-based test sclerosis. The blood glu-

26 DRUG TOPICS JULY 24 2006 www.drugtopics.com

 DT CAPSULES
cose test gives results in five sec- A wide range of test kits are now available, onds. According to Abbott, the
onds and stores 150 blood glu- including gene-based tests. system offers virtually pain-free
cose values. The blood pressure testing because it measures glu-
monitor stores 60 blood pressure cose levels using a 0.3-microliter
measurements and has a digital display. blood sample size. The meter also allows people with
Not standing on the sidelines, Life Fitness is offering the diabetes to test on less sensitive parts of the body such
Premium Portable Blood Pressure Monitor that measures as the forearm, thigh, and palm.
blood pressure and also screens for irregular heartbeats. The Ascensia Breeze Blood Glucose Monitoring Sys-
Forecare is jumping on the bandwagon with blood tem from Bayer Home Diagnostics offers patients an
pressure monitors that use BriteSensor Technology to easy-to-load Ascensia Autodisc 10-test disc. The device
provide blood pressure as well as pulse readings. can be used on the finger, forearm, palm, abdomen, and
Pharmacists can increase their bottom line by selling thigh, and results can be downloaded to a patient’s per-
these self-testing products, which range in price from $10 sonal computer using Ascensia Glucofacts software.
for a simple kit to $3,000 for more sophisticated devices.
They can also increase their store revenue by counseling Blood pressure monitors go high-tech
patients on how to correctly use these devices and by rec- A&D Medical, Milipitas, Calif., is rolling out LifeSource
ommending products that may improve their conditions. UA-767 Plus, a color-coded measurement system that is
Although figures for some of the newer home testing incorporated into the LifeSource automatic digital
categories are hard to come by, according to Informa- blood pressure monitor.
tion Resources Inc. (IRI), sales of blood glucose meters RESPeRATE, made by InterCure, is a portable, comput-
were up 2.2% for the 12 weeks ended Feb. 19, 2006, re- erized device that guides a patient through sessions of in-
sulting in $70.7 million in FDMX (food, drug, and teractive, therapeutic paced breathing that are supposed
mass-merchandisers, excluding Wal-Mart) sales. to be powerful enough to lower blood pressure. Using a
IRI also reported FDMX sales of pregnancy kits dur- breathing sensor, the device analyzes a person’s breathing
ing the 52 weeks ending April 16 totaled more than pattern and creates a personalized melody composed of
$228 million and sales of ovulation prediction kits dur- two distinct inhale and exhale guiding tones.
ing the same period came to $33.3 million.
A look at some of the innovative do-it-yourself tests Heart health
manufacturers are introducing underscores the financial Polymer Technology Systems, Indianapolis, is launch-
and professional rewards available for pharmacists who ing CardioChek for consumers who want to test for
sell these products and counsel patients on their use. total cholesterol, HDL cholesterol, ketone level, tri-
glycerides, and glucose.
Blood glucose category AccuTech offers CholesTrak Total Cholesterol. The
has a new attitude test determines a person’s cholesterol level in 12 min-
Chances are you’ve seen singer Patti LaBelle on TV and utes using two drops of blood from the fingertip.
in print commercials touting the OneTouch Ultra2
Blood Glucose Monitoring System from Lifescan, a Take a breath
Johnson & Johnson company. The new product is de- For asthma monitoring, there’s Microlife’s digital peak
signed to help diabetes patients see the impact of their flow meter with FEV1. Peak flow, or peak expiratory
food and portion choices on their blood sugar levels. rate, measures how fast a person can exhale air, deter-
The system, which provides test results in five sec- mining the function of the airways and indicating
onds, is designed to offer patients the option of viewing whether there is restriction or obstruction. FEV1, which
all of the meter’s information in Spanish and in English. is the forced expiratory volume after one second of ex-
It also provides the ability to flag haling, is usually decreased in obstructive airways.
and identify a specific blood sugar
result as coming from “before- For women only
meal” or “after-meal” treats. Finding out whether one is pregnant is easier thanks to In-
Abbott Diabetes Care recently verness Medical Innovations, which offers the Clearblue
launched FreeStyle Freedom, a Easy Digital pregnancy test. The test displays results in
blood glucose meter for people words, eliminating the need to interpret result lines. The
with Type 1 and Type 2 diabetes digital display spells out “Pregnant” or “Not Pregnant.”
OneTouch Ultra2 that provides results in five sec- Inverness has also unveiled the Accu-Clear Early

www.drugtopics.com DRUG TOPICS JULY 24 2006 27

COVER STORY

Pregnancy Test. The company claims the test Test, Anemia Meter (hemoglobin rapid test), Thy-
provides accurate and clear results in just three Newer roid Test, Prostate Test, and Cholesterol Panel.
minutes and that tests can be done as early as home For consumers who think they may have an al-
the first day of a missed period and can be per- lergy, ImmuneTech is offering MyAllergyTest.
pregnancy
formed at any time of day that’s convenient. The kit tests for 10 airborne and food allergens.
Pfizer is getting in on the act with the e.p.t. Cer-
tests The First Check 12 Drug Test is available from
tainty Digital Home Pregnancy Test Kit, which display First Check Diagnostics to detect the possible use
also provides a Pregnant or Not Pregnant readout. results of drugs.
Arben Bioscience, Rochester, N.Y., sells Sim- in words. EZ Detect markets a home test to detect the ear-
plicity The “No-Step” Pregnancy Test. Women ly warning signs of colorectal cancer. The product
are instructed to collect urine in the cup that is does not require laboratory processing and pro-
provided. Test results appear on the outside of the cup. vides results in two minutes. After a bowel movement,
The test requires no stick and no droppers. consumers are instructed to drop a test pad into the toi-
Church & Dwight claims that by using its First Re- let bowl. If blood is present, a blue color will appear
sponse Early Result Pregnancy Test, women can find within two minutes.
out if they are pregnant four days sooner than with oth- Consumers who want to measure their body fat in
er leading brands. The test can be used three days be- the privacy of their home can use Omron’s Body Fat
fore an expected period. Analyzer (HBF-306). The device provides a mode for
Conceivex, a Michigan-based company, is rolling out results for athletes and another mode for nonathletes.
the Conception Kit. The kit’s key feature is the Concep- NTD Laboratories, New York, has unveiled the Ultra-
tion Cap, a small silicone device shaped like a thimble Screen Instant Risk Assessment (IRASM), an at-home
for holding semen. It is then placed on the cervix for six blood test for chromosomal abnormalities.
to eight hours, giving the sperm an enhanced opportu- Nymox Corp. is offering Nicalert, a test that deter-
nity to pass into the uterus and fertilize the egg. mines a person’s level of exposure to tobacco products,
Synova Healthcare recently launched Fem-V, a non- including secondhand smoke. The product uses saliva
invasive diagnostic home test designed to assist women or urine samples.
in diagnosing vaginal infections. Parents can now test their children at home for signs
Mark for Life’s Breast Self-Exam Kit of an ear infection with MDI Instruments’ EarCheck
offers a way for women to do month- Middle Ear Monitor. For ages six months to young adult,
ly breast self-exams at home. The kit the monitor provides a red, yellow, or green reading.
includes a breast self-examination The higher the Red Level number, the higher the proba-
T-shirt that teaches proper tech- bility of middle ear fluid, a key sign of ear infections.
nique and allows women to record Home Access Health Corp., Hoffman Estates, Ill., is
the characteristics of their breasts by making available the Home Access HIV-1 Test. Test re-
marking their shirts. sults are available the next day. The test entails compre-
Women who want to identify what stage of meno- hensive pre- and post-test HIV counseling. The compa-
pause they are in can use the Estroven Menopause ny is also marketing the Hepatitis C Test.
Monitor from Amerifit Nutrition. The test detects ele- Bausch & Lomb is offering the Proview Eye Pressure
vated levels of follicle-stimulating hormone (FSH). Monitor Kit for self-monitoring of intraocular pressure
(IOP). Patients are instructed to press the device on par-
All about men tially closed eyelids. The test is intended for use in con-
Pria Diagnostics, Menlo Park, Calif., is making available junction with regularly scheduled doctor visits.
Element, a nonlaboratory test that measures conditions
associated with male infertility, including sperm count, How can R.Ph.s help home testers?
motility, and forward progression. There appears to be no letup in sight for the kinds of de-
Lake Consumer is marketing the BabyStart Male Infer- vices manufacturers are cranking out and the numbers
tility Test called FertilMarq. The test allows a man to of conditions that can be tested at home. So, the ques-
measure his sperm count in the privacy of his own home. tion that must be answered is, How should pharmacists
counsel patients on the use of these products?
À la carte tests Arthur Levin, MPH, director of the Center for Med-
Several companies market a variety of home tests. Biosafe ical Consumers, pointed out that pharmacists can help
has five home test kits on the market: Hemoglobin A1c patients understand the benefits and disadvantages of

28 DRUG TOPICS JULY 24 2006 www.drugtopics.com

COVER STORY
testing at home. Although the tests are convenient and
less costly than a visit to a doctor’s office, he said, “Do
we really want what we call the ‘worried well’ spend-
ing a lot of money and effort buying tests for everything
just because they are worried? That’s not a good thing.
The question is, what test and for what purpose?”
Levin said pharmacists can help patients who have
been diagnosed with a condition that requires
self-management to distinguish which home test
is relevant. For example, pharmacists could rec-
ommend hemoglobin A1c home tests to diabetes
patients.
Patients should also be aware that some test kits
have limitations. Test results may not be as accurate as
results from a more complex lab test, Levin advised.
Jennifer Staker-Johnson, R.Ph., executive committee
member at large, Ohio Pharmacists Association, echoed
Levin’s sentiments. Commenting on research she con-
ducted on home pregnancy tests, she said that while
these tests are a safe, private, cost-effective, and gener-
ally reliable means of self-health monitoring, women
should be aware of home pregnancy test limitations.
Many manufacturers’ marketing claims clash with clin-
ical reality. Amanufacturer may claim “results from day of
missed period to four days before missed period.” Staker-
Johnson said that no test will pick up all pregnancies that
early and some will miss a significant percentage. While
many manufacturers claim their products provide posi-
tive results in as early as one minute, she said that most
tests give more accurate results after 10 minutes. And
while marketers tout results of the testing may be easy to
read, sometimes line results may be faint and hard to see.
Staker-Johnson advised pharmacists to recommend
that women test their first morning urine, especially
with more sensitive tests on the market that claim they
can be used a couple of days after conception. “Pharma-
cists should develop a good working knowledge of the
home pregnancy test products available, procedures for
use, and limitations of those tests,” she advised.
In the case of self-monitoring of blood pressure, pa-
tients need to know that some devices may be inaccurate
unless calibrated. Pharmacists can advise patients who
are using devices that use batteries to change batteries
every month. Pharmacists can also inform patients that
coffee, cigarettes, exercise, stress, or a full bladder can
raise pressure and that a big meal can depress it.
Home testing for HIV/AIDS is another category in
which pharmacists can play a significant role. Levin
pointed out that more people may test themselves for
AIDS at home if they can do so privately; however, if
they discover, upon testing, that they have AIDS, they
may not have the appropriate counseling available.
www.drugtopics.com
Levin advised that if a person tests positive at home
for HIV, he should seek an outside laboratory test that
may be more accurate.
Peering into the crystal ball
What tests will consumers bring home in the future?
This fall, Genosis PLC, England, is planning to roll
out Fertell, a one-device fertility test-
ing kit for men and women. One test
screens for male fertility, the other
screens for female fertility. The
male test measures the concen-
tration of motile sperm. The fe-
male test measures the FSH. A
high FSH level indicates a
Fertell low number of remaining eggs
and is an indicator for reduced fertility.
WayPoint Biomedical, Huntington Beach, Calif., is
sending pharmacies the Drink Detective Drink Spik-
ing Test Kit and Awareness Program. The rapid test kit
can detect the presence of more than 60 “date rape”
drugs in seconds.
Rapid HIV tests are waiting in the wings. OraSure
Technologies is waiting for the FDA to approve its rap-
id HIV test for over-the-counter use. Chembio Diag-
nostics, New York, is also awaiting FDA ap-
proval for two of its three rapid HIV tests: HIV
1/2 Stat-Pak and Sure Check HIV 1/2.
Rapid
AccuTech is working on a home test kit called
High Density Lipoprotein Cholesterol.
HIV home
DNA Direct’s director of marketing Greg tests are
Kajfez predicted that there will soon be a drug waiting
metabolism test based on genetics. “It’s about in the
how your body metabolizes certain drugs wings.
based on your genetic situation,” he said.
Along with spanking new home test kits is
technology that transmits the test results to care-
givers and health professionals. Diabetech markets
GlucoMESSENGER, a device that makes it possible for
parents to stay connected to their kids who have dia-
betes. Using a tiny keyboard-enabled wireless device,
kids punch in codes for sending blood glucose, insulin,
carbohydrate, and exercise data to family members’
e-mail and cell phones as text messages.
Levin envisioned that home testing will increasingly
have patients using technology to self-manage chronic
conditions such as asthma, diabetes, and heart prob-
lems. “As we try to make the care of chronic diseases
more efficient and of a higher quality—which means
people managing a lot of their problems themselves—
you will see more of these home tests in a more sophis-
ticated form,” he concluded. DT
DRUG TOPICS JULY 24 2006 29