NEW YORK – Guardant Health has initiated its planned ECLIPSE trial (Evaluation of ctDNA Lunar Assay In an Average Patient Screening Encounter), a 10,000-patient observational study that will evaluate the performance of the company's Lunar-2 circulating cell-free DNA test in detecting colorectal cancer in average-risk adults.
ECLIPSE is now enrolling people aged 45 to 84 who are to receive a routine colonoscopy and meet other criteria, such as not having certain bowel-related health conditions, not having had a colonoscopy in the past 9 years, and not having had another non-invasive CRC test in the last three years. Guardant has said the trial will involve multiple sites, but the National Institutes of Health library page for the study currently lists only the Jackson Clinic in Jackson, Tenn.
The estimated primary completion date for the trial is January 2022, and its final completion date is listed as 2024. If successful, Guardant expects data from ECLIPSE to support a premarket approval submission to the US Food and Drug Administration.
PerkinElmer said this week that its board has declared a regular quarterly dividend of $.07 per share of its common stock, payable on Feb. 7, 2020 to shareholders of record at the close of business on Jan. 17, 202.
Illumina celebrated the fifth anniversary of its accelerator program. The sequencing firm accepted five new companies for the Accelerator's tenth funding cycle, including 4Basecare Genomics, a precision oncology company developing personalized diagnostics and treatment guidance for cancer patients in Asia.
Over its lifetime, the Illumina Accelerator has graduated 33 companies and helped them raise more than $300 million, Illumina said in a statement.
Affinimark Technologies said this week the US Food and Drug Administration has granted breakthrough designation for the company's cerebrospinal fluid test strip, which is intended for the real-time detection of cerebrospinal fluid leaks. It provides a positive or negative result when suspected fluid is tested, allowing clinicians to make a diagnosis and determination whether intervention is necessary. Affinimark President and CEO Ellie Tandler said in a statement that the product has completed proof of concept and prototyping, and the company is raising a Series C financing round to fund the clinical trial and analytical bench testing over the next 18 months for a de novo 510(k) submission to the FDA by Q1 2021.
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