FDA Oncology

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

Dive Brief:

  • The latest flurry of breakthrough device designation announcements positions​ ArcherDX, Geneoscopy and Phagenesis to benefit from regulatory perks.
  • The companies shared details Monday and Tuesday of breakthrough nods for a cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control. As of now, FDA does not publish a list of companies receiving the designation, but companies can announce them on their own.
  • The designations will see FDA offer additional advice on the development of the devices and potentially an expedited regulatory review.

Dive Insight:

Geneoscopy began the flurry of breakthrough designation notices with a statement about its colorectal cancer screening test. The test is underpinned by a method for extracting stool-derived eukaryotic RNA transcripts. By tracking RNA biomarkers, Geneoscopy thinks it can identify changes that occur downstream of cancer-causing DNA mutations, enabling it to detect tumors early.

Elsewhere in cancer tech, Boulder, Colorado-based biotech ArcherDX is working on a test designed to enable timely therapeutic interventions for people with cancer. Dubbed Personalized Cancer Monitoring, the company describes its technology as a way to “enable local labs to assess therapy success and identify disease recurrence much earlier than current standard of care such as imaging or antigen test modalities, making successful treatment more likely.” After inking a deal with Illumina last week, ArcherDX detailed plans to seek approval for the product.

ArcherDX previously received breakthrough designation for a pan-solid tumor device with genomic sequencing technology that can test blood and tissue, intended for local hospitals or regional reference labs.

A third FDA breakthrough status disclosed this week covers Phagenesis’ Phagenyx System, a device designed to restore neurological swallowing control using neurostimulation. By restoring swallowing control, Phagenesis aims to treat the dysphagia that prevents removal of breathing tubes in some tracheostomized patients.

Phagenesis has accrued data to support the use of the system, which already has a CE mark. A study published in The Lancet last year linked the system to an increase in the proportion of patients ready for decannulation. Nestlé Health Science, which entered into a staged deal to acquire Phagenesis in 2016, has supported work to generate clinical evidence on Phagenyx.

Having secured the breakthrough designations, ArcherDX, Geneoscopy and Phagenesis will benefit from additional communication with FDA and potentially expedited reviews. Recent changes mean there is also scope for the breakthrough devices to be more readily reimbursed.


Original Article: (https://www.medtechdive.com/news/archerdx-geneoscopy-phagenesis-win-breakthrough-device-designations/570470/)

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