CLN Article

Regulatory Roundup

FDA Approves Epigenomics’ Blood-Based Colorectal Cancer Screening Test

Epigenomics has received Food and Drug Administration (FDA) approval for Epi proColon, a blood-based colorectal cancer (CRC) test. It is indicated for CRC screening in average-risk patients who choose not to undergo guideline-recommended screening methods such as colonoscopy and stool-based fecal immunochemical tests. Epi proColon is an in vitro PCR assay that qualitatively detects Septin9 gene methylation in DNA isolated from plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue but not in normal colon mucosa. This tumor-specific methylation pattern can therefore be used to detect cell-free DNA shed into the blood stream by cancer cells. For patients, the test only requires a blood sample to be drawn during a routine healthcare provider visit that is then analyzed at a local or regional laboratory. No dietary restrictions or alterations in medication are required.

FDA’s approval of the test follows two requests from the agency for Epigenomics to provide further data on Epi proColon. Epigenomics originally conducted clinical studies on the test’s performance in patients who had already agreed to a routine screening colonoscopy; therefore, the agency requested in 2014 and 2015 that the company conduct additional studies demonstrating that the Epi proColon can increase rates of CRC screening in the intended use population of non-compliant patients.

Roche Test for Screening Blood Donations for Zika Virus Receives FDA Authorization

Under the Investigational New Drug Application protocol, the Food and Drug Administration (FDA) has authorized the use of an investigational test from Roche to screen blood donations for Zika in areas with active mosquito-borne transmission of the virus. This test resulted from an ongoing collaboration between FDA, other government healthcare agencies, and product manufacturers to develop Zika virus blood donation screening tests in order to help protect the nation’s supply of blood and blood components during the current outbreak.

Designed to run on the cobas 6800/8800 systems, Roche’s investigational assay is a qualitative in vitro nucleic acid screening test that directly detects Zika virus RNA in plasma specimens from individual human blood donors. It is expected that this test will enable blood establishments in Puerto Rico to resume collecting donations of whole blood and blood components after local blood collection was suspended on March 7 due to active Zika transmission on the island. The second stage of deployment for the cobas Zika test will be to prepare for screening blood donations collected in the southern U.S., which will most likely be impacted by Zika’s expanding range.

FDA, AACR to Hold Workshop on Advancing Liquid Biopsies

The Food and Drug Administration and the American Association for Cancer Research will co-sponsor a public workshop on July 19 in Washington, D.C., titled “Liquid Biopsies in Oncology Drug and Device Development.” The workshop aims to give attendees a state-of-the-science overview of liquid biopsies in oncology. It will also provide a forum to discuss the use of tumor-derived cell-free DNA in drug development and clinical use, current approaches to validation of related in vitro diagnostic devices or tests, and ways to accelerate development of these technologies to advance cancer care. To register to attend, visit www.aacr.org.

CE Mark Given to Cepheid’s Next-Generation MRSA Test

Cepheid has achieved the CE mark for the Xpert MRSA NxG, a next-generation version of its molecular diagnostic test for methicillin-resistant Staphylococcus aureus (MRSA). Xpert MRSA NxG has been updated to identify mecA- and mecC-containing MRSA strains and to detect new and emerging staphylococcal cassette chromosome mec subtypes. It also includes other upgraded features such as room-temperature storage, the ability to rule out empty cassette strains, and validation on multiple swab types. The test is designed to run on Cepheid’s GeneXpert System, which includes 22 other assays that are available internationally and span healthcare-associated infections, sexual health, critical infectious disease, and oncology.

Abbott Receives FDA Approval for Chronic Lymphocytic Leukemia Co-Diagnostic

The Food and Drug Administration has approved Abbott’s Vysis CLL FISH Probe kit to identify patients with B-cell chronic lymphocytic leukemia (CLL) who may be eligible to receive a targeted therapy. Using fluorescence in situ hybridization (FISH) technology, this companion diagnostic detects deletion of the TP53 gene in patients with CLL. This marker and several others tested for with the Vysis CLL are associated with both poor prognosis or patient outcomes and low response rates to therapies such as chemotherapy, a standard treatment for CLL. Patients with this deletion may benefit instead from treatment with AbbVie’s Venclexta (venetoclax) drug. The National Comprehensive Cancer Network’s non-Hodgkin’s lymphoma guidelines, which encompass CLL, recommend FISH testing at diagnosis and at relapse to help in selecting treatment options. About 5% of people with CLL have a TP53 deletion at diagnosis, but for patients with relapse or refractory CLL, the prevalence of TP53 deletion can be as high as 50%.

FDA Clears Siemens’ Differential Graves’ Disease Assay

Siemens Healthcare has received Food and Drug Administration (FDA) clearance for the Immulite 2000/2000 XPi TSI assay, a differential Graves’ disease test. This is the first automated and semiquantitative thyroid stimulating immunoglobulin (TSI) assay available for this condition. Graves’ disease is a common cause of hyperthyroidism worldwide, and is the result of TSIs triggering the uncontrolled production of thyroid hormones in the body. Unlike other currently available diagnostic tests, the Immulite 2000/2000 XPi TSI is designed to improve specificity for Graves’ disease by detecting the presence of thyroid-stimulating antibodies only. The test is also fully automated and produces results in 65 minutes, compared with manual TSI assays that can take hours to complete. Overall, incorporating the TSI assay into existing diagnostic algorithms has the potential to reduce overall direct costs of Graves’ disease diagnosis by up to 43%, according to Siemens.

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