Pathology, Inc. Introduces Blood Test to Aid in the Early Detection of Lung Cancer

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Leading Women’s Health Laboratory Services provider, Pathology, Inc., introduces blood test to aid in the early detection of lung cancer.
We are thrilled to be working with Oncimmume to offer this innovative oncology test to our physicians and hospital clients.

Pathology Holdings, Inc., parent company of its flagship laboratory Pathology, Inc., a premier national women’s health laboratory, today announced that it is entering into a marketing agreement with UK-based Oncimmune® to market its EarlyCDT®-Lung, the blood test that aids in the risk assessment and the early detection of lung cancer. Pathology, Inc. also announced that it has begun to market the test to its network of clients, including physicians, surgicenters, endoscopy centers, hospitals, and independent laboratories, in the California, Illinois, Missouri and Wisconsin areas.

Lung cancer is the leading cause of cancer death among men and women in the United States. Each year more people die of lung cancer than colon, breast, and prostate cancers combined. It is estimated that 226,160 new cases of lung cancer were diagnosed and 160,340 deaths occurred in 2012.

“We are thrilled to be working with Oncimmume to offer this innovative oncology test to our physicians and hospital clients” says Pathology, Inc.’s President and CEO, Vicki DiFrancesco. “This unique assay complements our extensive offering of high-value molecular and anatomic pathology testing services, and provides clinicians a means to help identify this deadly disease earlier.”

“We at Oncimmune are pleased to partner with Pathology, Inc. in offering our EarlyCDT-Lung assay,” said Greg Stanley, Chief Commercial Officer of Oncimmune (USA). “Pathology, Inc. has outstanding facilities and the highly experienced personnel to effectively make available this assay, which we believe can improve the well-being of many individuals who are at risk for developing lung cancer.”

Pathology, Inc., a wholly owned subsidiary of Pathology Holdings, Inc., is a full-service laboratory offering both clinical and anatomic pathology testing, with nationally recognized pathology expertise in gynecology, genitourinary pathology, gastrointestinal pathology, dermatopathology, hematopathology, and cytopathology.

Patient blood samples are analyzed at Oncimmune’s CLIA-certified laboratory. Nearly 2,000 physicians are using the test. Sixteen peer-reviewed publications support the performance and clinical utility of the EarlyCDT-Lung test. The test has high specificity (93%), 7 times fewer false positives and 7 times better positive predictive value (PPV) than CT, and >91% accuracy, when considering a population with 2% prevalence of lung cancer (20 lung cancers per thousand). Numerous leading academic institutions are running the test. An audit of clinical data from the first 1,600 patients tested by EarlyCDT-Lung validates its utility to detect early stage lung cancer and its overall performance. The Scottish government is conducting a 10,000 patient, randomized clinical trial to validate the economic benefit of the test in screening high-risk patients.

About Pathology, Inc.

Pathology, Inc. is a full-service provider of anatomic and clinical pathology testing services, with a 30-year foundation in the Women’s Health market. With expertise in reproductive FDA donor testing as well as anatomic, molecular, and digital pathology, the Company has built a solid reputation for quality and customer service with clients that include OB/Gyns, dermatologists, urologists, gastroenterologists, and family practitioners, as well as surgicenters, endoscopy centers, hospitals, and independent laboratories. Pathology, Inc. is located at four separate facilities; its Torrance headquarters, a second facility in Templeton, CA (Central Coast Clinical Laboratories), a third laboratory in Monrovia, CA, and a fourth laboratory in Wood Dale, Illinois.
Pathology, Inc., through its association with Affiliated Pathologists Medical Group (APMG), provides anatomic pathology testing services by pathologists, all of whom are board certified and have a variety of multi-specialty interests and expertise, as well as extensive cumulative experience in outpatient anatomic pathology testing services. Pathology, Inc. has provided pathology services to a variety of clients, including physician offices and pathologists for over 25 years.

About Oncimmune

Oncimmune is a privately funded company located in Nottingham, UK with US headquarters and a CLIA laboratory in metropolitan Kansas City. The company launched a proprietary platform technology for early cancer detection, called EarlyCDT® with the first commercially available test, EarlyCDT®-Lung a blood test to aid in the early detection and risk assessment of lung cancer, released in 2009. The EarlyCDT® platform technology measures autoantibodies (immuno-biomarkers) in blood that form early in carcinogenesis. When the body recognizes something as “non-self,” one of the ways it responds is for the immune system to produce large amounts of antibodies. The immune system does not normally produce antibodies against normal tissue antigens and therefore these immuno-biomarkers to cancer antigens provide high specificity for cancer.

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