Mode Diagnostics wants to bring the medical laboratory into your bathroom — with a mobile phone-size device that can detect signs of cancer right before your eyes.

The do-it-yourself test market, estimated at $2 billion to $3 billion globally, is expanding 20 per cent a year as new checks for colon and prostate cancer, HIV, chlamydia, stomach ulcer, sperm count and drug abuse take their place on pharmacy shelves alongside standards such as blood-sugar monitors for diabetics and pregnancy tests, according to Alan Hirzel, a London-based partner at consulting company Bain & Co. Behind the growth is a shift in behaviour as consumers become more aware of the signs and symptoms of disease and scour websites for tools to diagnose themselves. That trend may benefit Mode and boost shares of IP Group, which owns 45.7 per cent of the closely held Scottish company.

“Up until this point, medicine and health have been either treatment at the hospital or at the physician’s office,” Mode CEO Paul J Heaney said in an interview. “The third place is now the home.”

Mode expects to begin selling its colon-cancer test, the first in a series of do-it-yourself medical checks it’s developing, directly to patients for about £25 ($38) through online retailers such as Amazon.com in the second half of the year, Heaney said. The company is awaiting European regulatory permission this year, Heaney said.

Quick Results

The test, which involves inserting a stool sample into a canister containing a solution, takes less than three minutes to produce results, while patients may have to wait weeks after mailing specimens to a laboratory, he said. The company’s product is an improved digital version that requires fewer steps than older at-home colon tests. Patients who receive a positive result need to see their physician for confirmation, Heaney said.

Heaney expects Mode will receive clearance, allowing the colon cancer test to be sold in European Union countries by the end of the year, followed by a decision by the FDA in 12 to 18 months. It is also working on adapting the device’s electrochemical biosensor for use in chlamydia and other diseases.

‘Huge Appetite’

“There is a huge appetite for self-diagnostics” from people who want discretion or are anxious about hereditary conditions, Hirzel said in an interview. “It has the potential to reduce the cost of care and make health care more effective.”

1st Health Products, a UK provider of self- diagnostic tests that was taken private last year in a management buyout from ValiRx, sells 10,000 to 12,000 tests a year, about 16 per cent through websites. Direct sales are growing about 15 per cent, according to Patrick Kirby, a director and co-owner.

“Hospitals have realised they can’t do everything and patients are using the internet,” Kirby said in an interview. “It will grow if we get the right tests.”

Life-threatening Diagnoses

Regulators require reliability of new screens to be comparable to old-style laboratory tests, testing companies said. Mode said its measure device for colon cancer has 98 per cent accuracy and 1st Health Products and closely held Care Diagnostica Produktions say their products’ sensitivity in picking up signs of disease is about 90 per cent.

The biggest challenge for at-home tests in Europe is getting customers to pay for them when tests are offered at the doctors’ office for no additional charge, said Kim Scheuringer, CEO of Moellersdorf, Austria-based Care Diagnostica, which sells at-home tests for conditions, including colon cancer and chlamydia. The companies have also had to address the impact that a positive result may have on a customer who receives a life- threatening diagnosis at home alone rather than in the presence of a doctor or a nurse who can counsel them.

HIV Test

The Food and Drug Administration approved the US’s first rapid at-home saliva test for HIV, OraQuick by OraSure Technologies of Bethlehem, Pennsylvania, in July. The company agreed to provide a 24-hour support hotline and the FDA concluded the screen would identify 44,000 new cases of HIV and prevent 4,000 transmissions of the virus in its first year of use.

1st Health Products is seeking to raise $500,000 to $1 million to expand its range of tests and distribution of its products, Kirby said. His long-term goal is to develop the company over the next three to four years and then possibly sell it, he said. Heaney said a licensing deal or initial public offering may eventually occur, or the company could be sold.