Oncimmune® (USA) LLC Receives Laboratory Permit to Begin Offering EarlyCDT® - Lung in the State of New York

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Oncimmune® (USA) LLC announces that their test, EarlyCDT® - Lung, has been approved by the New York State Department of Health to be offered to state residents, making EarlyCDT-Lung available in all 50 states.

EarlyCDT-Lung Test

EarlyCDT-Lung Test

We are very excited to begin offering EarlyCDT-Lung in the state of New York.

Oncimmune® (USA) LLC, provider of EarlyCDT® - Lung, a simple blood test that aids physicians in the risk assessment and early detection of lung cancer, recently received a laboratory permit to begin offering EarlyCDT-Lung to residents of the state of New York. In obtaining this permit Oncimmune is now able to offer EarlyCDT-Lung tests in all 50 U.S. states.

EarlyCDT-Lung first became commercially available in the United States in 2009. This unique blood test is used to evaluate high risk patients for the presence of specific autoantibodies. Patients are considered high risk for lung cancer based upon smoking habits, age, family history and exposure to known carcinogens. The EarlyCDT-Lung test uses a panel of tumor antigens to detect autoantibodies which are elevated in patients when lung cancer is present. Because these autoantibodies appear in the earliest stages of lung cancer, EarlyCDT-Lung can assist physicians in determining a patient’s lung cancer risk before a tumor is detected. This vital information can then be used to aid physicians in the early diagnosis of lung cancer, even before a patient begins to display specific lung cancer symptoms.

In addition to New York, several other states also require laboratories to obtain approval, beyond that of the Clinical Laboratory Improvements Amendments (CLIA), to test clinical specimens from state residents. Since EarlyCDT-Lung was first introduced in the United States in 2009, Oncimmune had acquired approval to offer the test to residents in the other 49 states. Considered the most rigorous of the state-level clinical laboratory permit application processes, obtaining a Clinical Laboratory Permit in New York is a significant achievement for the entire Oncimmune team.

After successfully completing a rigorous application and review process, Oncimmune was awarded a Clinical Laboratory Permit by the New York State Department of Health on August 31, 2011. The process included a comprehensive review of clinical laboratory operations, materials, validation methods and data, as well as a thorough onsite inspection of the laboratory. Obtaining this permit is a milestone for the growing company, enabling Oncimmune to reach even more patients and aid more physicians in the diagnosis of this deadly disease.

“We are very excited to begin offering EarlyCDT-Lung in the state of New York,” said Dan Calvo, President and CEO of Oncimmune. “Receiving a Clinical Laboratory Permit in New York is truly an achievement for us, considering the rigor and breadth of the New York review process.”

Obtaining this is yet another notable achievement for Oncimmune in their efforts to make EarlyCDT-Lung available to physicians and their patients throughout the U.S. and the world. With plans for continued growth and the development of new cancer risk assessment tests, using their autoantibody platform, Oncimmune is poised to revolutionize cancer detection methods. Watch for more exciting announcements from the Oncimmune team in the coming months as they strive to make EarlyCDT technologies available to an even larger community of patients.

About Oncimmune (USA) LLC

Oncimmune (USA) LLC, founded in 2006, is an industry leader in early cancer detection. The company is committed to advancing early cancer detection through proprietary immuno-biomarker technologies based on biological technology identified by John Robertson, M.D., Professor of Surgery at Nottingham University, England, and Chief Scientific Officer of Oncimmune LTD. Ongoing research and development is conducted by Oncimmune under the direction of Professor Robertson. The company’s mission is to develop early cancer detection tests to identify more than 90% of solid-tumor cancers, which make up 70% of all cancers including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian. All testing is performed exclusively at Oncimmune’s CLIA (Clinical Laboratory Improvement Act) regulated laboratory located in the metro Kansas City area. Oncimmune (USA) LLC is a wholly owned subsidiary of Oncimmune LTD. Oncimmune LTD owns a portfolio of patents, including Patent Nos. 7,402,403 and 7,205,117, with five others currently filed and under review. For more information about Oncimmune, visit: http://www.hellohaveyouheard.com.


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Greg Stanley
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