Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.

Foundation Medicine Inc., of Cambridge, Mass., has had a busy fall, and it is showing no signs of letting up. For example, in the next 12 to 18 months, the company has high hopes for its Foundationone Liquid test, David Fabrizio, VP, product development, told BioWorld MedTech during a visit to its headquarters last month as the Medtech Conference wrapped up in Boston. "This is one that we are actively engaged in with FDA and planning to submit and hopefully get approval and launch mid-next year," he added.

There's a yin and yang to neoantigens, Alberto Bardelli told the audience at the 2019 annual conference of the European Society of Medical Oncology (ESMO) in Barcelona, Spain, last month. They contribute to tumorigenesis, resistance and tumor heterogeneity. But they are also often specific to tumor cells but not normal cells and "some," he said, "are actionable targets."

HONG KONG – In vitro diagnostic company Cube Bio Co. Ltd., of Seoul, South Korea, has inked an agreement worth KRW3 trillion (US$2.5 billion) with Moscow-based Standart-Biotest LLC to export its cancer self-diagnostic kits for five years to Russia and the Commonwealth of Independent States (CIS).

HONG KONG – South Korean biomarker-based molecular diagnostic firm Genomictree Inc. has built a U.S. unit in Pasadena, Calif., with an investment of KRW12 billion (US$10 million). The Daejeon, South Korean-based company first disclosed its plan to build the U.S. branch in March.

Lantheus Holdings, of North Billerica, Mass., has entered a deal to acquire New York-based Progenics Pharmaceuticals Inc., which develops medicines and other technologies to target and treat cancer. "This transaction leverages our core capabilities, including proven commercial and operational expertise while diversifying our revenue stream by broadening our presence in emerging uses of radioisotopes in precision diagnostics as well as the exciting field of radiopharmaceuticals in oncology treatment," Lantheus President and CEO Mary Anne Heino said on a call related to the deal.

While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.

The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.

Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again: Doctors don’t read drug labels. Yet drug companies continue to invest millions of dollars on aspects of clinical trials that are designed to inform labeling, and FDA reviewers spend untold hours scouring the data to ferret out what should be included in the prescriber information as contraindications, warnings and cautions, boxed warnings, the mechanism of action and clinical trial findings....