Guardant Health adds five epigenomic tools for cancer treatment selection
New breast and lung cancer applications aim to inform therapy choices when conventional mutation markers leave gaps.
Adrian Kessler
Breast and lung cancer treatment decisions could draw on five new epigenomic applications as Guardant Health, Inc. NASDAQGH unveiled an expansion of its Guardant360 Liquid blood test on Wednesday. The additions target an oncology business that generated US$231.3 million in third-quarter revenue, according to its Nov. 5 results.
In its Nov. 11 announcement, Guardant said the additions use its InfinityAI platform to combine genomic and epigenomic signals. It did not disclose prices, reimbursement changes or a date when clinicians would receive the expanded reports.
Guardant is a large California-based precision oncology company selling blood and tissue tests for cancer screening, recurrence monitoring and treatment selection.
Shares last closed at US$155.35 on Nasdaq on Nov. 10 at 4:00 p.m. EST, according to Google Finance NASDAQGH. That quote predates Wednesday's announcement and does not measure investors' response.
Predictors Extend Beyond Mutation Testing
The breast-cancer predictor is intended for patients with hormone receptor-positive, HER2-negative disease progressing after first-line therapy. Guardant said it could help identify candidates for selective estrogen receptor degraders, including patients whose tumours lack an ESR1 mutation.
For advanced non-small cell lung cancer, another predictor combines epigenomic characterisation of the tumour microenvironment with tumour mutational burden and microsatellite instability. Guardant said it is designed to assess the likelihood of benefit from immune checkpoint inhibitor monotherapy versus chemotherapy plus immunotherapy.
A separate application would identify patients who are PD-L1 negative without requiring a tissue sample. The company said that blood-based assessment could help identify patients who may benefit from adding chemotherapy to immunotherapy.
Read more: bioAffinity Technologies grows lung-test sales but flags funding needs
Guardant said epigenomic features identify 20 to 45 per cent of ALK fusions missed by genomic liquid testing alone. It also reported identification of over 250 per cent more MTAP deletions missed by genomic liquid testing alone.
The MTAP application is intended to inform enrolment in trials of PRMT5 and MAT2A inhibitors in advanced lung cancer. The Nov. 11 release gave no validation cohort sizes, confidence intervals or regulator assessment of the new predictors.
"Our goal is to translate deeper biological insights into practical information that gives physicians greater confidence in treatment decisions and brings us toward the fulfillment of what precision medicine can be," Guardant co-chief executive Helmy Eltoukhy said.
Oncology Test Volume Rose 58 Per Cent
Guardant reported 117,000 oncology tests for the quarter ended Sept. 30, up 58 per cent from a year earlier. Cash, cash equivalents and restricted cash totalled US$1.1 billion at that quarter-end.
Liquid-biopsy competitor Tempus AI, Inc. NASDAQTEM markets xF and xF+ panels covering 105 and 523 genes, respectively, according to its product page accessed Nov. 11. Both report blood tumour mutational burden and microsatellite instability status.
Its ordering workflow also includes preselected DPYD and UGT1A1 add-ons to help assess chemotherapy toxicity risks. Tempus describes the add-ons as identifying genetic variants that may influence how patients metabolise therapies, allowing clinicians to assess potential toxicity before treatment begins.
Read more: Novacyt reports Australian approval for 19-variant chemotherapy test
Tempus shares closed at US$80.54 on Nasdaq on Nov. 10 at 4:00 p.m. EST, according to Google Finance NASDAQTEM. Those prices provide a dated diagnostics-sector comparison; they precede Guardant's announcement rather than showing a response to it.
Guardant's next scheduled investor appearance is a Nov. 18 fireside chat at the Jefferies Global Healthcare Conference. The company has not scheduled a launch date for the expanded reports in its announcement, leaving the commercial timetable to be clarified.
