Ground-breaking Study confirms that the ISET by Rarecells® test allows early diagnosis of Lung Cancer in At-Risk Population through the Sensitive and Reliable detection of Circulating Tumor Cells

ISET® Test Detects Lung Cancer in Patients with No Symptoms Allowing For Successful Surgical Removal Prior to Metastasis—Large Phase II Study Will be conducted in the U.S.

NEW YORK--()--Rarecells®, the global leader in cancer’s early diagnosis using circulating tumor cells (CTCs) as advanced indicators of malignancies years before obvious symptoms and signs first appear, is proud to announce the publication of the first study to demonstrate that the ISET by Rarecells® test can allow the diagnosis of lung cancer among Chronic Obstructive Pulmonary Disease (COPD) patients. The independent study, “Sentinel Circulating Tumor Cells Allow early Diagnosis of Lung Cancer in Patients with Chronic Obstructive Pulmonary Disease” was just published in the Public Library of Science (PLOS) ONE open-access journal. The early diagnosis of cancer cells through the ISET®, a simple blood test, holds great promise for improved survivability of lung cancer, a form of cancer where patients are often asymptomatic until the disease is very advanced. Only 15% of lung cancer cases are found in the early stages, before the cancer has spread.i

“This study provides proof-of-concept for the early detection and treatment of cancer in patients who have not yet been diagnosed using traditional methods,” said Dr. Paul Hofman, lead author of the study. “This is extremely encouraging because most who die from lung cancer—as well as many of the most deadly tumors, including breast, prostate, ovarian and others—die because traditional diagnostic methods do not detect these tumors until it is too late. ISET holds the long-awaited promise of detecting cancer long before it devastates the human body. We are now eager to conduct a larger, multi-center study to further validate ISET as a tool that can help avert the tremendous suffering caused by late-stage tumors and the enormous cost to treat them.”

In the study, researchers used the ISET® (Isolation by Size of Tumor/Trophoblastic Cells) sentinel cancer cell searching technology to screen for CTCs in COPD patients. ISET® has an unparalleled sensitivity allowing it to detect 1 cancer cell in 10 ml of blood. The migration of CTCs into the bloodstream is an early event that occurs during tumor development and is a critical step in metastases. Secondary metastatic tumors—not primary tumors—are typically the principal cause of death in cancer patients. The study determined the presence of CTCs in 245 subjects without cancer, including 168 COPD patients, control smokers and non-smoking healthy individuals.

COPD patients were monitored annually by ISET® and low- dose spiral CT—the state-of-the-art-imaging tool to detect lung cancers. CTCs were detected by ISET® in 5 (3 %) of the 168 COPD patients, 1 to 4 years before a lung nodule became detectable by CT scans. This led to prompt surgical resection of the nodules. This strategy was clinically very successful as all 5 patients were free of any sign of tumor, including CTC detected by ISET®, sixteen months after surgery.

The ISET® test is highly sensitive for Circulating Cancer Cells (CCCs: cytopathologically validated CTCs), which, when detected, confirm the existence of a primary tumor that has yet to be diagnosed. Follow-up immunomolecular, as well as genetic analyses of CCCs, can determine the location of the original tumor and the DNA mutations present in the tumor. All of this information guides the choice of targeted treatment. Not only does the ISET® test hold the potential of early diagnosis of very dangerous “silent tumors”—for example, lung, pancreas, ovarian, breast and cervical cancers—it potentially could be used to monitor patients in remission for recurrence and to determine the effectiveness of cancer treatments.

“I’m extremely enthusiastic about this technology,” said Raymond Barnhill, MD, Professor of Pathology at UCLA’s David Geffen School of Medicine and Professor of Pathology at Curie Institute Paris. “This is a highly innovative blood filtration method to test for not only lung cancers, but all solid tumors at their earliest stages of development when they are simply not otherwise detectable with current technology,” added Barnhill, who has been studying the metastasis of cancer for nearly 30 years. “I’m encouraged by these results and believe that if they can be repeated in a larger, multi-center study, ISET could allow us to treat many of the most deadly cancers early in their pathology when they are typically much easier to cure.”

According to the American Cancer Society (ACS), lung cancer is the leading cause of cancer death among both American men and women. There were approximately 228,190 new cases of lung cancer diagnosed in the U.S. in 2013. According to the ACS, the 1-year survival rate for lung cancer is 44%. However, when all stages of lung cancer are combined, the 5-year survival rate drops to 16%. ii

About ISET®

The ISET® test is the most sensitive and the only diagnostic test (i.e. without false positive and without false negative results) for identifying circulating tumor cells, including “sentinel” CTC. The platform provides unbiased isolation of intact of CTCs/CTM from all types of cancer. It isolates both epithelial and mesenchymal tumor cells and has an unparalleled sensitivity of 1 tumor cell in 10 ml of blood.

About Rarecells®

Rarecells® was founded in 2009 by Patrizia Paterlini-Brechot MD, PhD, Professor of Cell Biology and Oncology at University Paris Descartes Paris, France, to validate and commercialize the company’s patented ISET® method. Rarecells Diagnostics is located in Paris, France and is a wholly owned subsidiary of Rarecells Holding, located in New York.

For more information, visit: www.rarecells.com and www.isetbyrarecells.com.

Ref.

i): http://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=35&ContentID=FAQLungCancer

ii) http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf

Contacts

Media Contact:
Baker & Yorke
Tim Baker, 216-338-8086
tbaker@baker-yorke.com
or
Founder contact: patriziapaterlini@gmail.com
Rarecells contact: johann.kalchman@rarecells.com

Release Summary

Ground-breaking Study confirms that the ISET by Rarecells® test allows early diagnosis of Lung Cancer in At-Risk Population through the Sensitive and Reliable detection of Circulating Tumor Cells

Contacts

Media Contact:
Baker & Yorke
Tim Baker, 216-338-8086
tbaker@baker-yorke.com
or
Founder contact: patriziapaterlini@gmail.com
Rarecells contact: johann.kalchman@rarecells.com