Cholesterol analyzers vary

Cholesterol analyzers vary – marketing opportunities for manufacturers of cholesterol-related drugs and diagnostic tests

Sharyn Rosenbaum

Cholesterol analyzers vary

With the growing concern and hype over the importance of reducing cholesterol intake and studies showing a link between elevated cholesterol levels and coronary heart disease, manufacturers of cholesterol-related therapeutic drugs and diagnostic tests are presented with tremendous market opportunities.

The demand for cholesterol testing in the United States is projected to increase by 29% to reach 250 million tests ordered in 1993, according to Biomedical Business International, Santa Ana, Calif. A large percentage of these tests are expected to be performed in alternate site testing centers, the report states. Another market research firm, Theta Corp., Middlefield, Conn., projects a worldwide growth rate for cholesterol test kits exceeding 100% in U.S. dollars between 1990 and 1995.

The current trend in cholesterol testing is using small chemistry analyzers in physicians’ offices or public settings. As a result of the shift in cholesterol testing from the hospital setting to alternate sites, small companies developing new testing methods will have profit potential throughout the 1990s, BBI predicts. And with cholesterol testing increasingly taking place in physician offices, public settings and as part of other screening programs, there will be continuing demand for compact, desk-top and portable chemistry analyzers.

State of the market

Approximately 60 companies are marketing test kits for cholesterol (total cholesterol, free cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, apolipoprotein Al, apolpoprotein B), according to a report by Theta Corp. About 48 companies have tests for total cholesterol, the reading most commonly given to people who are tested, the report states; tests for HDL or “good” cholesterol are marketed by about 41 companies and tests that detect LDL or “bad” cholesterol are marketed by about six companies. The determination of a person’s LDL cholesterol level has been found to be necessary in assessing risk of cardiac heart disease. The Adult Treatment Panel of the National Cholesterol Education Program for Classification of Patients recommended patient cholesterol cutpoints for total and LDL cholesterol in 1987.

Tests for apolipoproteins, proteins that direct lipoproteins to carry lipids to specific parts of the body, are marketed by about 17 companies (Apolipoprotein Al) and 20 companies (Apolipoprotein B). Apolipos have emerged as more accurate indicators of coronary heart diseases than HDL and LDL cholesterol levels, according to Theta Corp. Beginning in 1992, combined tests for LDL cholesterol and apolipoproteins will be performed on a routine basis, Theta Corp. predicts.

The market leaders in the physician office/screening market, according to BBI as of 1989 were Abbott Laboratories, Abbott Park, Ill., with a market share of 50.1%; Eastman Kodak Inc., Rochester, N.Y. (12.7%); Boehringer-Mannheim, Indianapolis (10.7%); Pont Co., Wilmington, Del. (7.5%); Inc., Elkhart, Ind. (3.0%); and others (16%).

Cholesterol guidelines

The guidelines issued by the NCEP for maximum blood cholesterol levels for all age groups has brought people with borderline high cholesterol into the high risk for cardiac disease category and normal people into the borderline category, according to Theta Corp. This has contributed and will continue to spur growth in the cholesterol testing and related products market. The NCEP also recently issued guidelines for national standardization of the measurement of cholesterol. The Laboratory Standardization Panel of the NCEP established goals for testing accuracy and precision equal to or less than a variance of 5% in 1988 and 3% by 1992.

As a result of both the patient and measurement guidelines, accuracy and precision in cholesterol testing methods and cholesterol testing systems has become an important and widely-discussed issue in the popular and medical press. Recently, The Journal of the American Medical Assn. ran a study that documented the accuracy and precision of compact chemistry analyzers (JAMA, March 2, 1990).

The study, conducted by Dr. Harvey W. Kaufman et al., evaluated five compact chemistry analyzers for the measurement of lipids–The Analyst, manufactured by Du Pont Co.; Ektachem DT-60, manufactured by the Clinical Products Division of Eastman Kodak; Reflotron, manufactured by Boehringer-Mannheim Diagnostics; the Seralyzer, manufactured by Miles/Technicon, Elkhart; and Vision, manufactured by the Diagnostics Division of Abbott Laboratories. The study concluded that under controlled conditions, two analyzers met the NCEP 1992 standards for accuracy and precision of cholesterol measurement.

Abbott Laboratories

Abbott’s Vision system, a desk-top blood analyzer, was one of the testing systems that had accuracy and precision for cholesterol measurement better than the 1992 target of 3%, according to Kaufman et al. (JAMA, March 2, 1990, p. 1248).

Vision runs 26 different chemistry tests, including a whole blood test that identifies HDL cholesterol levels from a fingerstick sample, according to Chuck Weber, a spokesperson for Abbott. The analyzer also provides a cardiac risk profile through the use of its built-in computer system, Weber said. It can produce test results in eight to 10 minutes.

Vision is marketed to more than 1,000 physicians by Abbott’s direct sales reps from its Diagnostic and Pharmacy Divisions, Weber said. Physician’s assistants and nurse are the system’s primary users. Abbott provides value-added services of training upon installment and a troubleshooting and quality control program when there is a software upgrade.

Abbott heavily promotes its system, conducting cholesterol screening at several high-attendance trade shows, including those of the American Hospital Assn. and American Heart Assn. The manufacturer also is “fairly aggressive” in advertising in the major physician journals and sends direct mail to physicians, Weber noted. On occasion, Abbott offers special pricing. The Vision’s list price is about $15,000.

Eastman Kodak

Eastman Kodak’s Ektachem DT-60 also had accuracy and precision for cholesterol measurement better than the NCEP’s 1992 target of 3%, according to the Kaufman study.

This desk-top analyzer is marketed by Kodak’s Clinical Products Division sales force of more than 100 reps to physician’s offices, hospitals, health departments, shopping malls, military vessels and other public settings.

Value added services include a field and sales organization of more than 5,000 people, a 24-hour, seven-day-a-week hotline for questions concerning the analyzer, product literature and a quality control system approved by the Coalition on Lab Assessment, said Scott DeMoulin, special accounts manager for the Clinical Products Division. Other services include the availability of loaner units, corporate medical testing and assistance in setting up businesses for the purpose of cholesterol screening.

Like Abbott’s Vision system, Kodak’s cholesterol analyzers can be seen on trade show floors, but Kodak itself does not run the cholesterol tests. The tests are conducted by companies that do business with Kodak.

All of kodak’s cholesterol systems (Ektachem DT-60, Ektachem 700 and Ektachem 500) have fingerstick, HDL capability, DeMoulin said. Kodak recently introduced the “soon to be available” Ektachem 250, which will be marketed to physician group practices and hospitals.

DuPont

DuPont’s physician office, desk-top system, Analyst, met the NCEP 1992 target range for precision measurement cholesterol, but not for accuracy, according to Kaufman et al. They noted that the accuracy problem could theoretically be easily rectified with better calibration.

DuPont markets its cholesterol systems through its direct sales force of approximately 100 reps. Value added services include customer training for one week at company headquarters, additional training, a 24 hour, seven-day-a-week hotline, and technical assistance in the field. It also has a newsletter called Technical Hints that goes to hospitals that use its Dimension or ACA analyzers.

DuPont attends trade shows but does not conduct cholesterol screening on the floors. Shows include those of the American Assn. of Clinical Chemistry, American Society for Clinical Pathology and the Clinical Management Assn.

The company also promotes its systems through advertising in trade journals such as Clinical Chemistry and Lab World, direct mail to physicians at the regional level and some telemarketing at the national level.

The Analyst’s list price is $15,000.

Miles

The Diagnostics Division of Miles Inc. recently introduced a desktop dry-chemistry analyzer to complement its Seralyzer blood chemistry anlyzer, which has been on the market since 1983. Clinistat was introduced in February and offers a higher throughput and a new technology, according to Miles. It lists for $9,995 compared to $4,495 for the Seralyzer III. The Seralyzer failed to meet even the 1988 recommended targets for accuracy and precision of cholesterol measurement, according to the study.

Both analyzers are aimed at the physician office lab market. Clair Hillard, senior market manager, chemical systems, said the Seralyzer is appropriate for the physician that’s looking to break into lab office testing, while Clinistat, based on different technology, is more suited for the larger office or lab. It can load 19 different tests at once and perform 80 tests an hour.

Miles does not sell these products direct to physicians but does have a sales force that supports its distributors and generates sales leads nationwide. Hillard declined to give the size of Mile’s sales force and the number of distributors it uses.

Other support functions include flexible financing, on-site training, seminars, product updates, newsletters and quality control programs. Also, Miles guarantees to accept Clinistat units in trade for new and future chemistry instruments.

The company advertises both analyzers in trade magazines and clinical journals, although it now runs more ads for the new Clinistat than for the Seralyzer III. It showed both units at the Health Industry Distributors Assn. convention in September and at the American Assn. of Family Practitioners convention in October.

The Seralyzer uses a serum-based system and can perform 19 different assays. Clinistat can run 14 assays. Seralyzer has been able to perform cholesterol tests since it was introduced in 1983 and added an HDL assay in May 1990. Both analyzers now offer cholesterol, HDL and triglyceride tests, the results of which can be used to calculate LDL levels.

Boehringer-Mannheim

In September, Boehringer-Mannheim added an HDL cholesterol test to the 14 other diagnostic tests that its Reflotron analyzer can perform, including one for cholesterol. Like the Seralyzer, Reflotron failed to meet the NCEP’s 1988 recommended targets for accuracy and precision.

The unit is marketed through distributors to the physician market. Boehringer supports its distributors with a full range of services, including periodic promotions, product literature, direct mail, print advertising and 800 numbers for service and sales leads. It also offers an advertising resource kit to help generate cholesterol screening interest.

This summer the company launched Hearts Across America, a nationwide program to generate more business for Reflotron owners and to take cholesterol testing to the public. “If you own a Reflotron, and are licensed to perform screening, we’ll generate leads for you, said Jeff Furst, market manager, cholesterol programs. Leads could come from hospitals, public health clinics, schools, health clubs, industrial settings or the Red Cross. Most Reflotron owners have signed up at no charge) for the program, Furst said.

The Reflotron costs $5,000.

COPYRIGHT 1990 J.B. Lippincott Company

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