Steady progress is happening in consumer self-test kits as new diagnostic technology supports at-home kits that produce results with accuracy approaching 90%

Because screening for colon cancer represents a potentially huge number of medical laboratory tests each year, many biotech companies are racing to develop reliable test kits that patients can use at home. But to be successful, the test kit must be cheap, easy for a consumer to use, and produce clinically useful results.

Home Test Promises Same Accuracy as Clinical Laboratory Test

That’s the goal of Mode Diagnostics, Ltd., a Scottish company that is poised to sell a consumer device that can detect signs of colon cancer at home in three minutes at an accuracy rate of 98%. Mode’s new device is an example of how innovative diagnostic technology is driving the market for fast, accurate consumer self-test kits—and pushing these tests out of the central clinical laboratory and into the home.

“Up until this point, medicine and health have been either treatment at the hospital or at the physician’s office,” stated Mode CEO Paul J. Heaney in a story published by Bloomberg. “The third place is now the home.”

This e-briefing is based on the Bloomberg story.

Company Will Sell At-home Colon Cancer Test through Online Retailers

For decades, the fecal occult blood test (FOBT) has been used to detect colon cancer. By the end of this year, Mode expects to receive clearance to sell its home version of the FOBT in European Union countries.

ModeDiagnostics-FOBT-Kit

Measure is a digital home monitoring fecal occult blood test provided by Glasgow, Scotland-based Mode Diagnostics, Ltd. The device, called Measure, can detect signs of colon cancer at home in three minutes at an accuracy rate of 98%. The company expects to have clearance to sell the test in Europe by the end of this year and to have U.S. Food and Drug Administration clearance within 12-18 months. It will be marketed by online retailers for $38. (Photo copyright Mode Diagnostics, Ltd.)

Following clearance by the EU, the company anticipates a decision from the U.S. Food and Drug Administration within 12 to 18 months. Also, Mode Diagnostics has hired a representative in China to establish a presence in that market.

“There is a huge appetite for self-diagnostics” from people who want discretion or are anxious about hereditary conditions, observed Alan Hirzel, a partner in the London office of consulting firm Bain & Company.

Mode Diagnostics has designed a device, called Measure, that uses proprietary electrochemical biosensors to detect the presence of blood in the stool. The test involves inserting a stool sample into a canister containing a solution. It produces results in less than three minutes.

The Glasgow-based company plans to sell Measure via online retailers, such as Amazon.com. The test will cost $38.

Growing Consumer Awareness Fuels Home Testing Market

Current estimates of the market for consumer at-home diagnostic testing is between $2 and $3 billion per year, according to Hirzel, who stated: “It has the potential to reduce the cost of care and make healthcare more effective.”

This is good news for policymakers struggling to reign in spiraling healthcare costs. “Governments have an interest in financing prevention,” observed Patrick Flochel, global head of Ernst & Young’s pharmaceutical practice. He added that devices like Mode’s at-home colon cancer test may eventually be reimbursed by payers.

Growth for the self-testing market is projected at about 20% per year, according to Bain & Company. “Hospitals have realized they can’t do everything and patients are using the Internet,” stated Patrick Kirby, a director and co-owner of 1st Health Products, Ltd. in Cranbrook, England. The company provides home diagnostic screening products. “[The home diagnostics market] will grow if we get the right tests,” Kirby added.

Cost and Counseling May Be Hurdles for New Home Diagnostic Tests

Despite attractive pricing and convenience, at-home diagnostic test companies may still face challenges. Price of these test kits could be an issue. Most Europeans can get an FOBT done through a physician’s office at no out-of-pocket charge. Beginning next year, the U.S Affordable Care Act will also make the FOBT available at no charge to patients.

A second concern is the potential impact on consumers who receive a life-threatening diagnosis at home without the support of professional healthcare personnel or counselors. Due to these concerns, home HIV tests are illegal in the U.K.

In the U.S., the FDA approved the country’s first rapid at-home saliva test for HIV in July. To address concerns about the impact of potentially devastating positive test results, the company agreed to provide a 24-hour support hotline. Further, the FDA concluded the screen would identify 44,000 new cases of HIV and prevent 4,000 transmissions of the virus in the first year.

Mode addresses the patient impact issue by advising users who obtain positive results for colon cancer using its product to see a doctor for further testing.

The pending launch of a home test kit that can deliver a colon cancer screening answer in three minutes with 99% accuracy is more evidence for pathologists and clinical laboratory managers that their centralized medical laboratories will see more competition from test kits designed for use by consumers or to be performed in all types of patient settings. Improved accuracy, lower cost and faster time-to-answer will drive this trend.

The counterpoint to the consumer self-test trend are the concerns, regularly voiced by pathologists and laboratory medicine professionals, that there are many ways that these test kits can fail to deliver an accurate answer. That’s because variability in the performance of various diagnostic technologies is a well-known element in laboratory medicine.

—By Karen Branz

Related information:

Do-It-Yourself Tests Enable Cancer Diagnosis in Bathroom 

CDC Colorectal Cancer Screening Guidelines

DARK Daily Press Release: New Fecal Occult Blood Testing Strategies for Colorectal Cancer Provide Labs with More Accuracy and Higher Profitability

White Paper: Cleaning Up Your Medical Laboratory’s FOB Testing Program:New Opportunities for Better Patient Compliance, Increased Accuracy, and a Happier Staff