Massive Bio Aims to Improve Clinical Trial Enrollment Rates With Oncology Registry, Matching Tool Bookmark

Excerpt:

“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.

“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”

Go to full article published by GenomeWeb on Mar 29, 2018.

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Why Can’t Dying Patients Get the Drugs They Want? Bookmark

Excerpt:

“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.

“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.

“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”

Go to full article published by The New York Times on Mar 23, 2018.

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CMS Starts to Cover Broad Cancer DNA Tests, Boosting Foundation, Thermo Bookmark

Excerpt:

“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.

“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”

Go to full article published by Xconomy on Mar 19, 2018.

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A New Regulatory Threat to Cancer Patients Bookmark

Excerpt:

“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.”

Go to full article published by The Wall Street Journal on Feb 25, 2018.

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New Guidelines on Clinical Trial Design for Patients with Brain Metastases Bookmark

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

Go to full article published by ScienceDaily on Dec 30, 2017.

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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change? Bookmark

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

Go to full article published by The Washington Post on Dec 17, 2017.

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