Regulatory Information

Oncimmune’s testing is performed in our registered, high-complexity laboratory. We meet or exceed all CLIA regulations and are compliant with OSHA regulations (OSHA – Occupational Safety & Health Administration).

Oncimmune has met all criteria for laboratory accreditation through COLA, achieving a survey with no citations: “The standards your laboratory maintains demonstrate your commitment to quality. Your emphasis on quality leads to reliable test results, which are essential in assuring excellence in patient care. We also compliment your laboratory staff for its dedication and continued support of COLA standards.” (COLA Certificate)

Following an assessment by BSI, Oncimmune’s Quality Management System is certified to EN ISO 13485:2012 for the design, development and manufacture of in vitro diagnostic immune biomarker devices for early detection of solid tumour cancers (ISO Certificate).

EarlyCDT®-Lung is a CE marked test for the in vitro detection of a panel of seven lung cancer autoantibodies in humans to aid in the early detection of lung cancer in moderate and high risk individuals (CE marking).

Oncimmune® (UK) Ltd complies with the Data Protection Act 1998.

Insurance & Reimbursement

In the US, EarlyCDT®-Lung may be billed to Medicare Part B and most major private insurances by the test provider using CPT code 83520 x 7 units. Patients should contact their chosen test provider for insurance billing questions.

In the US, if the patient chooses to pay out-of-pocket, the self-pay price is comparable to many US insurance plans’ co-pays or deductibles for other cancer detection tests. Oncimmune’s US Client Services Department at +1-888-583-9030 can advise on self-pay options.

The cost of EarlyCDT-Lung is not currently covered by the NHS or medical insurance in the UK. Patients will pay for the cost of the test themselves. The cost varies according to the test provider.



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