Educated Consumers Buying 250-Bioassay Lab Test Panel

Biophysical Corporation of Austin, Texas, Enjoys Growing Market

CEO SUMMARY: Biophysical Corporation is creating a new, direct-to-consumer market for laboratory testing. Its unique approach is to offer 250-bioassay test panels—along with a staff physician review of results—to the educated, informed consumer. Testing multiple biomarkers makes it possible to identify disease and predict risk in asymptomatic patients. High profile customers such as Oprah Winfrey and Martha Stewart have discussed their positive experiences with this testing in television interviews.

LISTENING TO THE VOICE OF THE CUSTOMER led to the creation of an intriguing new business model for laboratory testing by Biophysical Corporation, based in Austin, Texas.

For the past four years, Biophysical has marketed a 250-assay test panel directly to consumers. Called the Biophysical250, it is more than a wellness panel and is specifically designed to accurately diagnose disease in an asymptomatic patient.

On both these counts, Biophysical is blazing a new path for the laboratory medicine profession. First, it is demonstrating how a well-designed, extensive panel of laboratory tests can detect disease and other health conditions that have gone unobserved by the consumers’ healthcare providers.

Second, it is serving a group of consumers that proactively monitor their health. These individuals have both the education and the financial resources to intelligently watch their health and pay for any medical services that maximize their health and well-being.

Of note to the wider lab testing industry, the Biophysical250 test panel has earned plaudits from such well-known individuals as Oprah Winfrey and Martha Stewart. Both women have discussed their Biophysical250 lab test experience in television interviews.

In fact, the Biophysical250 has been discussed on five different Oprah shows. Oprah even told her television audience that the Biophysical250 laboratory test panel was such an important window on an individual’s health status that she was giving this $3,400 comprehensive testing panel to her friends as a gift!

Biophysical’s new laboratory testing business model is based on unique diagnostic technology familiar to many lab managers and pathologists. It is the xMap multi-analyte bioassay system developed at Luminex Corporation by founder and former CEO, Mark Chandler, Ph.D., during the 1990s.

In 2002, Chandler saw how xMAP could be a tool to help the pharmaceutical industry identify, in advance, which patients would have an adverse response to new drugs. This innovative molecular technology, which he invented in collaboration with his brother, Van Chandler, analyzes 100 unique biomarkers using just a single drop of blood.

100 Assays Per Specimen

“It gives drug developers a cost-effective way to predict drug toxicity,” stated Chandler. “It uses small quantities of specimen and reagent, provides a quick, reliable answer, delivers high sensitivity and specificity, and allows the drug developer to perform up to 100 assays per specimen simultaneously.”

Back in 2002, the problems with prescription drugs Rezulin and Baycol were still fresh in the minds of all drug developers. Makers of these drugs were forced to pull them from the market shortly after FDA approval, when some patients experienced severe adverse effects or death. “I recognized how xMAP technology could be used to provide toxicity testing services to pharmaceutical companies,” recalled Chandler. “That same year, we established Rules Based Medicine, Inc. (RBM), a bio-marker-testing laboratory facility, to offer this service to the pharmaceutical industry.”

The story now takes a fascinating twist that leads directly to the creation of Biophysical Corporation in 2004. “The idea for the Biophysical250 lab test panel evolved out of the technology’s ability to accurately diagnose a disease in an asymptomatic patient, often years before it’s found by other means,” he said.

“As pharma companies began using RBM to screen candidates for clinical trials, something very unexpected happened,” he stated. “Both research scientists conducting the clinical studies and pharma executives began sending specimens of their own blood for analysis, along with blood samples from trial participants! They wanted to know if they had any undetected diseases or sinister biomarker combinations that predisposed them to a disease.

“We quickly realized that, if these scientists were using our multi-assay test panels to evaluate their own health status, this diagnostic service would have appeal for others in the healthcare community,” he added. “It was August 2005 when Biophysical Corporation launched the Biophysical250 lab testing panel.”

Expanding Consumer Trend

Chandler is quick to point out that the concept of proactively testing an asymptomatic individual to accurately diagnose previously undetected disease meets the need for a growing number of consumers in this country. “Since the millennium in 2000, consumer interest in proactive medicine, personalized healthcare, and preventive products and services has increased at a
steady rate,” observed Chandler.

“In this decade, integrative medicine has become mainstream and a variety of consumer-oriented products and services have emerged in response to consumer demand,” he commented. “Laboratory professionals have watched consumers support things like patient self-test devices, the full-body MRI, personalized medicine, bio-identical hormone replacement, and other anti-aging therapies.

“It is consumer support which has fueled the strong growth in ‘boutique’ or ‘concierge medicine’ in recent years,” said Chandler. “These are all examples of personalized healthcare services focused on wellness, rather than illness—supported by the willingness of financially better off individuals to pay extra to get these services.

“For example, in a concierge medicine setting, patients pay their doctors an annual retainer of $1,200 to $25,000 to receive premium healthcare services,” he noted. “The concierge physician provides them with house calls, a comprehensive physical, access to a doctor day or night, extended office visits, and other services not covered by insurance.

“We designed the Biophysical250 and our related test panels specifically to serve consumers who are informed, involved in managing their health, and keenly interested in understanding their risk factors for a variety of diseases,” explained Chandler. “These are motivated individuals—different from the traditional patient who typically only visits the doctor when he/she feels bad.

“In fact, if you believe that the future of healthcare is preventive medicine and personalized medicine, then the Biophysical250 test panel now serves that first wave of informed, educated consumers who are acting proactively to forestall disease and maintain their health at peak levels,” observed Chandler. “Like the clinical trials scientists who sent in their own blood, these consumers are taking active steps—and spending their own money—to optimize their personal health.”

Having explained how Biophysical, Inc., came into existence and the profile of the consumers and patients it serves, pathologists and laboratory administrators will be interested to learn more about the design of the Biophysical250 lab test profile and how it is used by consumers and their physicians.

Simple Concept For Testing

“The concept is simple,” explained Randy Marfin, Vice President of Sales and Marketing for Biophysical Corporation. “The Biophysical test panel combines all known biomarkers that define specific medical conditions or diseases into a single, relatively inexpensive test panel.

“The xMap technology we use is the secret behind the Biophysical250,” he continued. “First, because it uses tiny amounts of specimen per assay, we typically need to collect only three red top (8.5 mil) tubes and two purple top tubes (4 mil) from the patient. By contrast, drawing the quantity of blood needed to run 250 individual assays using traditional laboratory testing methods would be impossible without killing the patient.

“Second, the economics of xMap technology are favorable for this application,” Marfin said. “If a patient was to go to a clinical laboratory and order the same 256 bio-markers in the Biophysical250, it would cost about $40,000, compared to the $3,400 cost of the Biophysical250 test panel.

“Recognizing that consumers have different needs, Biophysical Corporation offers seven different panels of tests,” continued Marfin. “For example, Biophysical CA/CV is designed for people who want to enhance their personal health surveillance program for cancer and cardiovascular disease. It uses multiple biomarkers, supported by clinical studies, that collectively deliver high sensitivity and specificity compared to a single biomarker.

Test Is In Best-Selling Book

“In the best-selling book YOU: Staying Young, authors Michael Roizen, M.D., and Mehmet Oz, M.D., discuss how factors like exercise and nutrition play a role in health. At their request, we created the ‘Biophysical You’ test panel to include specific biomarkers discussed in this book.

“Our seven test panels meet specific needs for different consumers,” he com- mented. “Each test in the seven panels looks for biomarkers associated with specific diseases, conditions, or bodily functions. Each test panel varies in price according to the number of biomarkers analyzed, from as little $475 for Biophysical CA/CV, which checks for cancers and cardiovascular disease, up to $3,400 for the Biophysical250—the full works.”

“Biophysical is a consumer-driven model, selling directly to consumers willing to invest in their health,” explained Chandler, noting that Biophysical test panels have done particularly well with consumers living in South Florida. “Thanks to the Internet, today’s healthcare consumer is more informed than ever, which is why the market for wellness-oriented products and services is booming.

“The consumer-driven health market is growing unbelievably fast,” he added. “Consumers want to make use of advances in medical science. And they also don’t want their health determined or limited by what insurance will or will not pay.”

Marfin points out that biomarker testing presents an opportunity to dramatically cut healthcare costs. “These test panels combine all biomarkers that help define a specific medical condition into a single, low-cost test, which enables the physician to quickly create the most accurate picture of a patient’s health.

“Take diabetes,” continued Marfin. “This is an expensive problem. The American Diabetes Association estimates that a diabetes patient costs the healthcare system an extra $6,650 per year. In the vast majority of cases, Type II diabetes can be prevented or postponed with diet and exercise. Here is where biomarker panels have value. Early detection is critical for a successful intervention program and glucose testing alone may not be adequate to help physicians identify high-risk patients that are in a pre-diabetic condition. A physician must look at all the relevant biomarkers to identify those patients who are pre-diabetic. Once identified, those patients can make the lifestyle changes required to prevent diabetes.”

Another way that Biophysical’s test panels contribute to better use of healthcare resources is as a screening tool to determine which individuals are candidates for more expensive imaging procedures. “Mammography is an example,” said Chandler. “Although it is among the most trusted of imaging tests, it produces false-positives 95% of time.

“We predict a convergence of imaging and biochemical diagnostics will take place as a way to end wasteful or unnecessary imaging procedures,” he explained. “Doctors will order cost-effective, multi-assay biomarker screening tests first, then follow up—when indicated—with more expensive imaging procedures that provide greater details about the patient’s condition.”

More Consumer Awareness

In its early years, Biophysical built its business by focusing on the informed consumer and using public relations activities. Greatly expanded consumer awareness of the company’s testing services resulted from mention of the Biophysical250 in the best-selling book YOU: Staying Young, along with attention generated by the television interviews of Oprah Winfrey and Martha Stewart.

Now Biophysical Corporation is marketing itself to physicians who have organized their medical practice to serve the educated and proactive patient. “We want to turn actionable knowledge generated by the Biophysical250 over to doctors who can determine and start appropriate treatments,” noted Marfin. “We find that physicians with a concierge practice or boutique component actively promote preventive medicine and they are quick to see the benefits of the Biophysical250 for their patients.”

Both Chandler and Marfin believe biomarker testing will one-day be a routine part of everyone’s health care. “When this happens, pathologists will need to operate more like radiologists,” predicted Marfin, who noted that radiologists are skilled at offering a course of treatment along with radiology reports.

Physician Review Of Results

“In fact, part of every Biophysical250 is a review of the results by our staff physicians with both the referring doctor and the consumer,” explained Marfin. “These reviews can take more than an hour, depending on the findings for an individual patient. As a laboratory testing resource, we recognize how important it is for referring physician and the consumer to fully understand the information produced by these sets of biomarkers and what medical actions and lifestyle changes are indicated. We insist that our staff physicians have a direct role in communicating the findings.”

Off the radar screen of the laboratory testing industry, Biophysical Corporation has quietly been creating a new laboratory testing business model. Because it is oriented to serve preventive medicine and personalized medicine, it provides pathologists with an interesting window into laboratory medicine’s future.

That future promises an active, consultative role for pathologists. “As more consumers demand more sophisticated lab testing services, pathologists will have an opportunity to partner with those physicians practicing personalized medicine,” Marfin concluded. “This consulting relationship will work because pathologists will be giving actionable information and treatment recommendations based on an evaluation of multiple biomarkers.”

Biophysical Test Panel Has Robust Lab Technology

FOR MORE THAN A DECADE, laboratories have been able to use the same combination of simple, robust technologies that make up the Biophysical250 laboratory test panel.

Biophysical’s technology is the xMAP system licensed from Luminex Corporation. It starts with microbeads impregnated with precise proportions of two fluorescent dyes in 10 different intensities to create a set of 100 unique microspheres. Every bead set has its own color-coded spectral address.

Each bead set is then coated with an immunochemical reagent specific to a particular bioassay that binds with the specific biomarkers of interest in the blood sample.

Using a proprietary analyzer consisting of sophisticated lasers, state-of-the-art digital signal processors and a fluidic process similar to that used in flow cytometry, patient samples are analyzed and results reported in real time. As beads flow through the optic chamber, one laser excites the internal dyes and classifies which biomarker is being tested. The other laser excites the external reporter dyes and quantifies the amount of biomarker present in the sample.

The testing process is fast, highly sensitive and specific, and uses minimal amounts of specimen and reagent—compared to conventional diagnostic technologies.

 

Preventive and Personalized Medicine Goals Served by Biophysical250 Lab Test Panel

CUSTOMERS OF BIOPHYSICAL CORPORATION typically fall into two categories. One category is made up of consumers who are proactively managing their health. The second category consists of physicians who are incorporating the seven Biophysical test panels into their medical practice.

The value of these test panels in early detection of disease is demonstrated by many stories. Rick Nagel, CEO of Oklahoma City-based Acorn Ventures, was so impressed with Biophysical250 he purchased it for himself and his entire management team. Nagel learned about the test from his wife, whom had suffered from pain in her abdomen until Biophysical helped correctly diagnose her problem, after which she was properly treated.

“I looked at it [the cost] as a worthwhile investment in our management team,” Nagel said, noting that he was glad to pay for the baseline knowledge, but then it is the responsibility of each executive to work on risk factors and follow-up with specific testing. “A couple [of executives] had cardiac issues and needed to change behaviors. But at the macro level, I was pleased to learn that our management team has a good health baseline.”

Integrated Medicine

Among physicians, Paul Rothwell, M.D., is a first-mover in Integrative Medicine. He established a wellness component to his regular family practice in Bethany, Oklahoma. “I wanted to provide private-pay patients with the latest evidenced-based anti-aging treatments shown to provide optimum health,” stated Rothwell.

He offers Biophysical laboratory test panels through his anti-aging, regenerative medicine, consumer-oriented practice, Wellness and Longevity, LLC. This specialty practice evaluates patients through physical examination and targeted laboratory studies to identify potential problems and deficiencies. The information is used to develop a plan to get the body back in balance, which might include supplements, bioidentical hormone therapy, and nutritional counseling.

Rothwell learned about Biophysical when one of his patients showed up for an appointment with his Biophysical test report booklet. “At first, I was surprised by the expense, but then I saw how comprehensive it was,” he said. “We spent an hour together looking it his results.

Patient Wanted Testing

“This patient decided to have the Biophysical test panel after his brother suffered a heart attack,” recalled Rothwell. “He was in his early 50s and had no symptoms of cardiac issues. The Biophysical results indicated that his vital numbers were perfect, but did indicate the need for imaging tests that I may not have otherwise ordered for this patient.”

Discussing his personalized medicine practice, Rothwell said the specialty practice allows him to go beyond insurance limits to proactively manage a patient’s health. “For instance, insurance companies may cover a TSH test to screen for thyroid disorder,” he noted. “But an entire thyroid profile is often required to make a good medical decision.

“They taught us in medical school to be reactive and treat diseases. But in treating the masses, if we approach medical care proactively, rather than reactively, healthcare costs would come down,” emphasized Rothwell. “Comprehensive biomarker testing like the Biophysical panels is the future of medicine.”

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