A new tool for personalizing therapy for asthma patients has become available with FDA 510(k) clearance of Niox Mino, a hand-held point-of-care device for the measurement of airway inflammation manufactured by Aerocrine (New Providence, New Jersey), a subsidiary of Aerocrine AB (Solna, Sweden).

“It’s a very exciting product for the asthmatic population, which is more than 20 million in the U.S.,” Trevor Bourke, president of Aerocrine, told Diagnostics & Imaging Week.

“Physicians will be able to monitor a patient’s inflammatory process, and predict a patient’s response to therapy and the risk of an asthma relapse. It is really a remarkable move forward and will allow the asthmatic population to have fewer emergency room days and fewer days off from work.”

Aerocrine has marketed Niox Mino in Europe and other locations for several years. A stationary version of the device — Niox Flex — has been available to U.S. hospitals, but the hand-held Niox Mino is for physician’s offices.

Niox Mino provides measurement of fractional exhaled nitric oxide (FENO), for assessing asthma-related airway inflammation. Bourke said Niox Mino is the first hand-held device to measure airway inflammation, key to successful management of asthma.

FENO measurements by Niox Mino compare favorably to other asthma monitoring methods in terms of providing accurate results, according to the company. FENO measurement is an earlier metric than spirometry – a test of the lungs’ breathing capacity – to inflammation changes following allergen exposure, making it a more sensitive marker of the disease. (And a study recently printed in the Annals of Internal Medicine recently warned against the overuse of spirometry, particularly in patients non-symptomatic for chronic obstructive pulmonary disease because of the frequency of over-diagnosis using this method. COPD.)

About 12 inches tall, the Niox Mino device has a screen at the top end for the operator to observe results and a mouthpiece through which patients, at a doctor’s office, do inhalations, with exhalations done on the other end.

Patients are coached by the doctor or nurse on how to inhale and exhale into the machine, with continual feedback provided and by a high and low tone and flashing lights.

“Basically every time an asthmatic patient comes in to see the physician every three to six month, they use Niox Mino, allowing the physician to adjust dosages of inhaled corticosteroids and other medications,” Bourke said.

If an increase in medication is needed, another test on Niox Mino lets doctors know when they can reduce those dosages when an inflammatory episode has passed.

Physicians also will be able to identify patient non-compliance with medications, and can adjust the dose of medication based on the individual patient’s needs.

“Historically, monitoring inflammatory airway diseases such as asthma focused primarily on measuring symptoms and lung function,” said Bourke. “The availability of Niox Mino in the U.S. represents a major advance in asthma management, because for the first time, doctors can measure the underlying inflammation that causes asthma within a few minutes directly in their offices.”

Niox Mino, which costs about $5,000. or can be rented, is reimbursable in the U.S. through CPT code 95012. Bourke said physicians may opt to rent rather than buy because Niox Mino has capacity for 1,500 usages or three years of use.