Dive Brief:

• Guardant Health raised its full-year revenue guidance by around 10% after blasting past expectations in the third quarter, the company reported Thursday.

• The liquid biopsy company has bumped up its sales outlook in each quarter of 2019 as a result of fast-growing demand for its genomic tumor profiling tests and companion diagnostic services.

• Guardant is looking to new products to maintain momentum, leading it to start a clinical trial during the quarter of its rival offering to Exact Sciences' Cologuard.

Dive Insight:

Guardant went into 2019 expecting to generate sales of no more than $135 million. Nine months into the year, the company has already eased past that target, racking up sales of $151 million over the first three quarters. The top of Guardant's full-year revenue target is now $207 million, more than 50% above the initial best-case scenario.

The latest double-digit jump in the guidance follows another quarter of broad-based growth at Guardant. Revenues from Guardant360 and GuardantOmni rose 185%. Guardant’s smaller development services business posted a 156% increase in sales. 

Guardant attributed the ongoing traction with 360 and Omni to increases both in test volumes and revenues per test. Both sides of the precision oncology unit contributed to the growth. Clinical volumes grew 89% while biopharmaceutical volumes were up 111%. And revenue per test from biopharma customers grew 15% as companies moved from 360 to Omni.

The triple-digit jump in development service revenue stemmed from the companion diagnostic and regulatory approval work Guardant does for biopharma companies. 

Having outperformed sales expectations in 2019, Guardant is now working to ensure it maintains its upward trajectory. Those efforts could receive a boost from forces outside of Guardant’s control. Talking to investors on the third quarter conference call, CEO Helmy Eltoukhy flagged an upcoming reimbursement change as a potential tailwind. 

"We believe a final Medicare pan-cancer LCD could be issued by the end of the year. This LCD could potentially expand Medicare coverage of the Guardant360 assay to over a dozen advanced solid tumor cancer types. These tumor types represent a vast majority of all solid tumors," Eltoukhy said.

Guardant is also working to position its pipeline and portfolio for further growth. In the third quarter, Guardant filed for premarket approval of Guardant360, reflecting its belief FDA authorization will become increasingly important for the commercial prospects of diagnostic tests in the U.S. and overseas. 

The team also began a registrational study of LUNAR-2, a blood test Guardant wants to position for use in the screening of adults who have an average risk of developing colorectal cancer. If successful, the 10,000-subject study could establish the test as a rival to Exact’s Cologuard. ClinicalTrials.gov lists the estimated primary completion date of the trial as the start of 2022.