Cancer immunodiagnostic test, 10/16

At the AACC show 2016

October 2016—Boston-based Oncolab’s AMAS test detects circulating antibodies to a specific antigen (protein) produced by most types of cancer. The AMAS test can be used as a diagnostic aid in cancer occurrence and recurrence. More than 60,000 tests have been performed, and both its sensitivity and specificity are over 90 percent.

The company is planning to release a point-of-care version of its diagnostic test in 2017. Currently, blood samples must be converted to serum and then shipped overnight with dry ice refrigeration to the company’s CLIA-inspected lab in Boston for the test to be performed. Being able to administer the test more easily and closer to the point of care, whether at clinics, hospitals, or doctors’ offices, could make a dramatic difference in follow-up and early detection of recurrence for cancer survivors.

More than 1,000 patients have had the test administered five or more times, each over a period of months or years. The company is conducting a survey of these patients, and initial indications are that the benefits of the test are especially clear when used to pick up cancer recurrences at an early stage.

The antimalignin antibody in serum (AMAS) test, in contrast to other cancer blood tests, measures the concentration of a serum antibody, which has been shown to be elevated in early-stage cancers irrespective of location. The AMAS test is permitted to market by the FDA and is paid for by Medicare. Importantly, the company does not recommend the use of the test as a screen for populations at large, due to the difficulty of interpreting and following up on even a relatively low proportion of false-positives (in the single percentage digits in the case of the AMAS test).

Oncolab, 617-536-0850