路透复述MannKind Furoscix ReadyFlow获FDA批准并将于8月底在美国上市

We also report on an experimental diagnostic approach that can ​detect tuberculosis exposure and infection at an earlier stage than current methods.

MANAGING HEART FAILURE FLUID BUILDUP AT HOME

U.S. ‌patients with heart failure or kidney disease whose bodies periodically get so filled with fluid they have trouble breathing will soon be able to avoid infusions in the emergency room via a quick, self-administered injection at home.

This apparent breakthrough for heart failure patients, an under-the-skin autoinjector called the Furoscix ReadyFlow from MannKind (MNKD.O), delivers ​a diuretic called furosemide that helps the body get rid of extra water and electrolytes. It won U.S. approval late ​last week.

Until now, so-called fluid overload was primarily treated with furosemide given intravenously.

The U.S. Food and Drug Administration ⁠approval of the autoinjector was based in part on data published last autumn in Clinical Therapeutics showing it achieved equivalent urine output, sodium ​excretion, and potassium excretion at six, eight and 12 hours compared to intravenous furosemide.

An earlier version for at-home use called Furoscix On-Body Infuser, ​also from MannKind, was approved by the FDA in 2022. That device infused the drug over five hours rather than the 10 seconds required by the new autoinjector.

The Furoscix ReadyFlow injection is expected to be commercially available in the United States by the end of August.

BLOOD TEST DETECTS TB AT VARYING EXPOSURE ​LEVELS

A simple experimental blood test appears to accurately diagnose tuberculosis among patients with varying degrees of exposure to the disease, a leading cause ​of death worldwide, researchers reported on Tuesday.

TB is typically diagnosed by analyzing mucus secretions coughed up from the lungs and airways.

“However, not all patients can ‌produce sputum ⁠when they first seek medical care, especially those with early disease or those with low bacterial burden,” study leader Dr. Sheng-Wei Pan of Taipei Veterans General Hospital in Taiwan said in a statement.

“For that reason, non-sputum-based diagnostic tools are urgently needed,” he said.

TB is almost always curable with antibiotic therapy when the M. tuberculosis bacteria is detected in the initial stages of the disease, the researchers noted.

Using a newly ​designed biosensor, researchers were able to ​sensitively detect a blood marker ⁠produced by the bacteria called ESAT-6, they reported at the Association for Diagnostics & Laboratory Medicine meeting in Anaheim, California.

While ESAT-6 has been studied before, most earlier sensors used to detect it have not been sensitive ​enough to distinguish active pulmonary TB from latent TB infection, TB exposure, or other lung diseases.

The ​ESAT-6 marker did an ⁠excellent job of differentiating between TB- and non-TB patients, the researchers said.

They saw the lowest levels in uninfected people who had been exposed to infected contacts, medium amounts in those with latent tuberculosis, and the highest levels in patients with active TB.

Unlike biomarkers that measure the body's immune ⁠response to ​infection, ESAT-6 is derived directly from the TB bacteria.

“We believe this is one ​reason why it performs so well in identifying active TB,” Dr. Pan said.

“We are currently planning a prospective study to further evaluate if this can be used in a ​real-world clinical setting,” he said.

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