Hirotsu Bio Science this month launched the N-Nose plus pancreatic cancer test kit, which is marketed directly to consumers in Japan. The target is to bring the test to the US market by 2023.
The user sends his urine sample via a special mail bag to a laboratory, where it is placed in a petri dish along with a species of nematode or worm. The creature, known scientifically as C. elegans, has a much stronger sense of smell than a dog’s, the company says. According to the company, the worm’s smell leads to cancer cells.
This makes the 1-millimeter-long animal a powerful diagnostic tool, said Hirotsu Bio Science founder and CEO Takaaki Hirotsu, who has researched the worms for 28 years.
Hirotsu said, “The most important thing with the early detection of cancer and these types of diseases is being able to sense the slightest trace. And in this regard, I think that machines can’t fight against the abilities that living things have.”
Hirotsu Bio launched its first consumer N-NOSE test in January 2020. The test claims to be able to tell whether a user has a high risk of developing the cancer or not. About 250,000 people have taken initial tests, with around 5%-6% found to be at high risk.
In its latest version, the company altered the nematode’s genetic code so that the creatures would stay away from pancreatic cancer samples. Hirotsu Bio started its test for pancreatic cancer due to its difficult diagnosis and rapid development.
In the coming years, the company hopes to launch targeted tests for liver, cervical and breast cancer.
Pancreatic testing kits can cost as much as 70,000 yen ($7,000), relatively expensive for diagnostic tests in Japan, which has a national healthcare system and fixed prices for drugs and treatment procedures.
The price, as well as the television ad featuring caricatures of worms and pancreas, is part of the process of developing the brand, said Hirotsu, adding that the price could fall as the company scales up.
Some doctors have criticized this kind of approach to consumers and doubted the usefulness of the results for medical purposes.
Masahiro Kami, head of think tank the Medical Governance Research Institute in Tokyo, said the number of false positive test results could far exceed actual cases of pancreatic cancer, rendering the results “unusable.”
Hirotsu Bio responded by saying that the accuracy of N-NOSE remains valid compared to other diagnostic tests and is intended as an early detection tool that can guide patients for further tests and faster treatment.
Hirotsu added, “Pancreatic cancer is almost undetectable in its early stages, and there is no test in the world to detect the earliest stages of pancreatic cancer. But since last year, we have confirmed that N-NOSE reacts to early stages of pancreatic cancer. We are therefore able to develop the world’s first test to detect early stages of pancreatic cancer.” [uh/ab]
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