The PCR-based test analyzes mitochondrial DNA to detect prostate cancer in advance of biopsy, independent of prostate-specific antigen levels and age.
The validation of its current CLIA testing comes as Biocept is in the early stages of expanding to provide kit versions of its liquid biopsy tests.
The company has collected initial evidence for an algorithmic method to predict immunotherapy response, and is studying its technology in treatment monitoring.
The researchers said the test performed well in distinguishing patients with or without complications and proved itself better than frequently used clinical variables.
The firm has a 180-day grace period in which to regain compliance, by maintaining a $1.00 minimum closing bid price for at least 10 consecutive business days.
The lab can now receive US specimens for testing with its LiquidHallmark blood test that detects cancer-causing gene mutations and viruses.
Called the "Ccheck Prostate Cancer Confirmation" test, Anixa's assay integrates flow cytometry and machine learning to identify evidence of cancer in a person's bloodstream.
According to Natera CEO Steve Chapman, the agreement will not detract from Natera's own efforts to establish its exome sequencing-based Signatera assay.
The companies will use Foundation Medicine's FoundationOne CDx test as the baseline to define a set of unique variants that the codeveloped assays will monitor.
The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.
The award will fund optimization of the Hemopurifier exosome isolator, with an eye towards developing applications in cancer research and clinical care.
The Royal Oak, Michigan-based startup will use the funding to support development and commercialization of its pan-disease diagnostic testing platform.
The company will work with the Genome Institute of Singapore to create a test for breast cancer recurrence prediction using its circulating tumor cell platform.
The partners will use Biolidics' circulating tumor cell retrieval system to evaluate the cells' utility as biomarkers of patient response to cancer treatment.
The researchers aimed to develop a test that could help clinicians determine whether a patient would respond to therapy, before the onset of treatment.
The firm, which is working to reaccelerate its test validation effort, incurred a loss of $5.4 million, or $.10 per share, slightly above the analysts' consensus estimate.
Buoyed by a 26 percent increase in test volume, the firm's revenues were $1.2 million for the quarter, compared to $822,000 last year.
The company is forging ahead with its Signatera liquid biopsy circulating tumor DNA minimal residual disease (MRD) test and Prospera transplant assessment assay.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
The firm will begin a verification study later this month using its cell-sorting platform and molecular analysis tool on patients with a pelvic mass scheduled for surgery.