Leader McCarthy and the House Valley Fever Task Force Support Immuno-Mycologics, Inc.’s Bid for Grant Funding

Today, Congressman McCarthy, as Co-Chair of the Congressional Valley Fever Task Force, along with 16 of his colleagues in the House, sent a letter to National Institutes of Health (NIH) Director Francis Collins in support of grant funding to help move a Valley Fever diagnostic tool into primary care settings, such as the family doctor's office. Currently, Immuno-Mycologics, Inc. (IMMY) has a rapid diagnostic tool, which consists of a dipstick test to detect the presence of Valley Fever antibodies in human blood in as little as 30 minutes. This dipstick test, the Total Antibody Lateral Flow Assay, has been approved by the U.S. Food and Drug Administration for use in hospitals and laboratories, but not primary care settings. If awarded, this NIH grant funding would help IMMY conduct the necessary studies to obtain FDA approval of the Valley Fever dipstick test for use in local, community-based doctors' offices. This would be an important step forward for health care providers in diagnosing Valley Fever, lead to more precise, timely treatment and prevent the unnecessary use of antibiotics that potentially result from a misdiagnosis.

Congressman Kevin McCarthy released the following statement on the letter:

"In the past six years we have made tremendous strides to provide resources to the public health community to tackle this vexing illness. But communities throughout the Valley continue to suffer from Valley Fever without the needed medical support for diagnosis and treatment. The potential for IMMY approval in primary care settings is especially important to rural communities that are so common in the Central Valley and care for many of our neighbors. With a more available and accurate diagnosis test, we will all be able to better understand and fight Valley Fever."

Excerpts from the letter:

"Currently, diagnosing Valley Fever requires either blood work or CT-scans, both of which take multiple days at a minimum to produce results. IMMY's Coccidioides Total Antibody Lateral Flow Assay (LFA) detects the presence of Valley Fever antibodies in as little as 30 minutes and can rule out suspected cases of Valley Fever. The development of a quick and accurate method to diagnose Valley Fever is an important step forward to help health care providers expedite the diagnostic process, leading to more precise treatment, as well as preventing the unnecessary use of antibiotics."

Full text of the letter can be read here.

Background:

· Valley Fever is a respiratory infection caused by inhaling the spores of a fungus commonly found in the soil of the American southwest; the Center for Disease Control reported nearly 12,000 Valley Fever infections in 2016.

· Current tests for Valley Fever require extensive laboratory work that is often time consuming and necessarily definitive.

· By more quickly and accurately identifying Valley Fever cases, this could help patients start medical care sooner and potentially reduce symptoms and the severity of the disease.

Rob Purdie, President of the Valley Fever Americas Foundation, commented on the Task Force's efforts:

"As someone who is living with this disease, I cannot emphatically enough endorse the need for a Valley Fever screening test in primary care settings. The Valley Fever Americas Foundation is very excited to support the efforts of the Congressional Valley Fever Task Force in addressing the needs for awareness, research, and improved clinical care for those living or traveling through areas impacted by Valley Fever. This grant would create a diagnostic tool to narrow the treatment gap substantially. As Valley Fever cases continue to rise, the need for a test like the LFA is more urgent than ever, and we are excited to see a path forward to the primary care setting for this test."