SEATTLE, WA--(Marketwired - January 06, 2017) - Indi (Integrated Diagnostics®) today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) and national Medicare MolDx program leader, has posted a local coverage determination (LCD) for Xpresys Lung 2. Xpresys is a breakthrough, molecular diagnostic blood test designed to provide physicians with an objective tool to address a major medical dilemma -- the management of indeterminate lung nodules. The company also announced it has raised $6.1 million in Series C funding from Baird Capital and InterWest Partners.
"We are delighted that Xpresys Lung 2 has been recognized by Palmetto GBA as meeting the high bar of evidence for coverage by Medicare's MolDx program," said Albert A. Luderer, Ph.D., chief executive officer, Indi. "This is an important step in making the test widely available to patients and physicians."
Xpresys Lung 2 is a noninvasive blood test intended to assist physicians in identifying benign patients who present with a low to moderate risk lung nodule that is 8 - 30mm in diameter. These patients are typically described as having 'indeterminant' nodules that are diagnostically challenging.
Indi estimates the U.S. market opportunity for Xpresys exceeds $1B annually and will increase as lung cancer screening expands nationally. Between 60 to 70 percent of the current market is comprised of Medicare eligible patients.
"Xpresys Lung 2 combines the individual patient's clinical factors -- those recommended by the American College of Chest Physicians -- in combination with two proteins whose expression levels are altered in early stage lung cancer," said Paul Kearney, Ph.D., president and chief scientific officer, Indi. "An algorithm combines the clinical factors with the detected protein levels into an easily interpreted negative predictive value that allows physicians to be confidant the nodule is benign."
The test is performed early in the patient's work-up and prior to deciding whether invasive diagnostic procedures such as bronchoscopy, needle biopsy or diagnostic surgery should be deployed. Xpresys Lung 2 simply requires a blood sample to be analyzed at Indi's Seattle laboratory. The lab is CLIA licensed and accredited by the College of American Pathologists.
Xpresys Lung 2 assists physicians in determining which patients are best managed conservatively. Those patients, whose test results indicate their nodule is likely benign, can be managed with 'watchful waiting' -- a conservative standard of care involving a series of low-dose CT scans over a two-year period. This active surveillance of the patient's lung nodule is a safety net and allows early detection of growth and a therapeutic intervention if a nodule is malignant.
"Xpresys Lung was designed to address the most pressing need in nodule management -- reducing the number of unnecessary invasive diagnostic and surgical resections preformed on benign lung nodule patients," said Luderer. "Previous clinical trials have demonstrated that 35 percent of nodule surgeries are performed on benign patients. By accurately identifying the lowest risk patients, Xpresys Lung 2 is anticipated to significantly reduce the number of benign patients undergoing unnecessary invasive procedures. We estimate typical cost savings for elimination of benign surgery approaches $35,000 per patient."
Indi (Integrated Diagnostics) is redefining molecular diagnostics and creating powerful new tools for physicians to non-invasively assess and more effectively manage complex diseases to improve patient outcomes, reduce complications, and lessen costs to the healthcare system. With the company's breakthrough test, Xpresys Lung 2, which measures blood proteins and identifies lung nodules with a high probability of being benign, physicians have the potential to reduce risks and the need for unnecessary invasive procedures.
The company was co-founded in October 2009 by systems-biology pioneer Dr. Lee Hood, a recipient of the National Medal of Science from the U.S. government. His groundbreaking research is based on a systems biology approach, which measures hundreds of protein biomarkers found in blood to report on the physiological state of the body's 50 major organs, such as the lungs.
Foundational intellectual property is exclusively licensed from the Institute for Systems Biology and Caltech. Learn more at www.indidx.com