Studies feature the LUNAR-2 liquid biopsy and its potential to improve colorectal cancer screening rates 

REDWOOD CITY, Calif., May 02, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) presents new data at Digestive Disease Week (DDW) 2020 that highlights the performance of its LUNAR-2 assay and reinforces its potential to improve colorectal cancer (CRC) screening rates by offering a simpler blood test that overcomes barriers associated with current testing methods. The LUNAR-2 assay is currently being evaluated in a large-scale registrational trial to detect CRC in average-risk adults.

“Despite the recent challenges of the COVID-19 pandemic, the ability to hold scientific discussions on research of cancer and other diseases, even in a virtual capacity like this year’s DDW, is essential to ensure our collective fight against cancer continues to advance,” said Helmy Eltoukhy, PhD, co-founder and CEO. “This year, we are excited to have three poster presentations scheduled during the meeting, including one poster of distinction on the performance of our LUNAR-2 assay study.”

Presentations:

• Abstract #Sa1651 and Poster of Distinction: Plasma based cell-free circulating tumor DNA (ctDNA) assessment for non-invasive detection of colorectal cancer (CRC).
  
  Summary: In a new cohort analysis of colonoscopy screened negative patients (n=185) the assay demonstrated improved specificity of 94% at a target specificity threshold of 90%. The specificity improvement also resulted in improved sensitivity for CRC detection over previously reported performance. Some of the increase in specificity may correspond to undiagnosed malignancies or adenomas in unscreened participants in the presumably healthy control group.
  Presentation timing: Saturday, May 2, 2020.
  
  
• Abstract #Mo1617: Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: A systematic review.
  
  Summary: Systematic literature review shows that primary care physicians have a diversity of opinions on patient-level barriers to CRC screening and strategies that may be useful to overcome them. Rates of CRC screening may be improved with approaches that are more affordable and easier to complete, but may still require provider communication regarding the recommendation.
  Presentation timing: Monday, May 4, 2020.
  
  
• Abstract #Tu1974: Evaluating the number needed to screen and the number needed to invite to screening for colorectal cancer as a quantitative measure of the clinical impact of diagnostic technologies.
  
  Summary: This study reports on the early development of a model to assess the number of patients needed to screen (NNTS) and number needed to invite to screen (NNTI) for a CRC screening test. The data show that a diagnostic with high sensitivity, but low compliance may have a higher NNTI value as compared to a diagnostic with comparable sensitivity but higher compliance. The findings suggest that a lower NNTI score is an impactful assessment metric which can describe the true benefit of screening for colorectal cancer where compliance remains a significant societal challenge.
  Presentation timing: Tuesday, May 5, 2020.

The data being presented lend further support for the company’s first indication in early cancer for the detection of colorectal cancer in asymptomatic individuals. The tumor biology is well captured by the company’s blood-based technology; low CRC screening compliance represents a clear unmet medical need (one-third of adults in the U.S. are not up-to-date with recommended screening¹); and existing pathways are in place for both downstream intervention and reimbursement, making it easier to drive clinical use.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding LUNAR-2 assay’s potential to increase patient compliance and improve colorectal cancer (CRC) screening rates, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, and in its other reports filed with the Securities and Exchange Commission, including in its Quarterly Report on Form 10-Q for the period ended March 31, 2020, when filed. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Media Contact:
Anna Czene
press@guardanthealth.com

Becky Lauer
becky.lauer@uncappedcommunications.com

References

1. Joseph DA, King JB, Richards TB, et al. Use of Colorectal Cancer Screening Tests by State. Prev Chronic Dis 2018;15:170535. DOI:http://dx.doi.org/10.5888/pcd15.170535

 

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