LUNAR Assay For Early Cancer Detection By Guardant Health
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LUNAR Assay For Early Cancer Detection By Guardant Health

In order to stop cancer at its initial stage, a novel liquid biopsy test has been launched by the Guardant Health San Francisco. It acts by detecting both genomic alterations and epigenomic signatures in a single blood draw. The LUNAR assay is a novel blood-based assay designed to detect early-stage cancer and recurrence of the disease, which is now available for biopharmaceutical and academic researchers for research use.

At J.P.Morgan Healthcare Conference, Daniel Simon, Guardant’s senior VP of biopharma business development stated that many of their academic and biopharma partners are thinking about taking their clinical programs into neoadjuvant and adjuvant settings. The Lunar assay is built upon 80,000 samples gathered from cancer patient after testing with the company’s Guardant360 test along with additional whole genome sequencing data.

The chief agenda of the company is to overcome previous challenges faced in detecting early-stage disease like biological noise mutations associated with aging and limited sensitivity of genomic-only tests where less tumor DNA to be found in comparison to the late stage of cancer detection covered by the Guardant360 tests. Simon said that detecting epigenetic markers, such as differences in the methylation of DNA from

tumor cells compared to that from healthy cells might play a critical role in increasing the sensitivity of the test. Giving an example he added further that Researchers at the University of Queensland, Australia found that the dense clusters of methyl groups lining tumor DNA can cause the molecule to fold into shapes which can be easily detected by naked eye via a simple test.

The assay further improvises Guardant360’s performance by reporting genomic alterations at allele frequencies as low as 0.01%. The company is planning to launch a clinical version of the test, for investigational use in prospective studies Company, is planning to launch a clinical version of the test in the next few months.

In the first half of the year 2019, Guardant is planning to submit Guardant360 test to the FDA for premarket approval with a further plan to submit its Guardant OMNI panel for tumor mutational burden score by the end of 2019.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary blood tests, vast datasets, and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced-stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Press Release by Guardant

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