A negative preliminary decision regarding reimbursement for the company's flagship colon cancer screening test in the US remains an issue for the company.
The Chinese company is branching out from its core genomics business to liquid biopsy cancer screening and monitoring as it eyes areas for global expansion.
The startup aims to combine its microfluidic platform with a circulating tumor DNA-based assay offered by a potential partner and launch the test by 2022.
The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
The company plans to show new data for its Signatera oncology test at three upcoming conferences this year, including in breast cancer and bladder cancer.
The liquid biopsy's firm's net loss rose significantly year over year, but it beat the top line consensus Wall Street estimate, with total revenues of $74.6 million for the quarter.
Bluestar hopes to launch a pan-cancer, DNA methylation-based liquid biopsy assay as a laboratory-developed test out of an envisioned CLIA-certified lab in San Diego.
Though Guardant and Foundation have pioneered a path through the FDA for liquid biopsy tests, label differences highlight complex choices for oncologists.
The companies said their partnership will allow pharmaceutical partners to measure both ctDNA and CTC biomarkers from a single blood draw when conducting drug trials.
Inivata's Radar assay will be used to monitor circulating tumor DNA from multiple tumor types in trial participants following treatment with Maverick's MVC-101 candidate.
The firm said it made changes to address the pandemic that allowed it to submit its Parsortix cell-sorting system to the FDA for use in metastatic breast cancer.
The firm is engaged in multiple clinical validation trials and aims to raise more than $100 million to launch its Helio Liver Test in the US early next year.
The company's acquisitions of Thrive Early Detection and Base Genomics are meant to accelerate its development of a liquid biopsy multi-cancer screening test.
The company also acquired DNA methylation analysis firm Base Genomics for $410 million and said it plans to raise $869 million in a direct stock offering.
The firm's assay, dubbed MesoFind, uses an immunomagnetic capture method to identify surface antigens on mesothelioma pleural cells in a patient's blood sample.
Researchers showed that ctDNA levels predicted who would respond to first-line immune checkpoint inhibition but were not useful in second-line therapy.
