News that Abbott Laboratories’ (NYSE:ABT) hepatitis C test has been cleared by the U.S. Food and Drug Administration was a significant milestone for personalized medicine.
The Abbott RealTime HCV Genotype II test identifies the hepatitis C virus genotype that patients carry. It can differentiate genotypes 1, 1a, 1b, 2, 3, 4 and 5 by using a sample of an infected patient’s blood plasma or serum. The test is only approved for patients with chronic hepatitis C infections. It’s not approved for use as a diagnostic test or as a screening test for the presence of hepatitis C genetic material in the blood, according to an FDA statement.
Even with those restrictions, the Centers for Disease Control and Prevention reckons there are about 3.2 million people in the country who have a chronic hepatitis C infection. The results will help physicians decide the best course of treatment for each patient.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
It’s a significant development because different hepatitis C genotypes respond differently to available drug therapies. The test will lead to better patient outcomes.
Earlier this week, Saladax Biomedical launched its MyCare portfolio of diagnostic tests to help physicians optimize a patient’s chemotherapy exposure. Oncologists use the blood tests to get specific information about each patient’s exposure to chemotherapy. The tests help physicians make more informed decisions on drug dose to maximizes the therapy’s effectiveness and limit potential side effects.
Abbott’s and Saladax’s tests represent an important milestone because of the scope of the patient population that these tests will help. This isn’t about the part of personalized medicine that gets the most attention — genetic testing. But they will each have a substantial impact and reflect some of the changes we are beginning to see in how we think about treating chronic conditions, not to mention hold the potential to reduce healthcare costs.
