Researchers at Queens University Belfast have published findings where a multi-marker panel of 4 proteins (CA125, phosphatidylcholine-sterol aceltransferase, vitamin K-dependent protein Z, and CRP) has the potential to diagnose epithelial ovarian cancer (EOC) one to two years earlier than current methods.
The SpotProfiler is a prime candidate to translate this type of research finding into an easily accessible medical tool for physicians with its multi-marker protein microarray approach.
San Francisco-based DotLab has raised $10 million in series A funding to continue development of its DotEndo test, a liquid biopsy test that detects disease-specific biomarkers for endometriosis in blood or saliva samples. The test can also be used to track therapy response and recurrence.
Resolution Bioscience's blood test was granted a breakthrough device designation by the FDA in May. It is currently being used to help develop a companion liquid biopsy test for Janssen’s PARP inhibitor Zejula (niraparib) drug in patients with metastatic castration-resistant prostate cancer.
Connecticut-based Tangen has raised $9 million in a series A round to put the company’s TangenDx platform into the clinic in two trials focused on obtaining FDA clearances in diagnosing infectious diseases and commercialize in 2020. TangenDx is a DNA/PCR-based test system that is battery-powered and delivers results in less than one hour.
CA19-9 is a sugar molecule present on many proteins. It is often elevated in patients with pancreatitis and pancreatic cancer; hence, it has been used for more than 30 years to assess disease burden. Recently, scientists at Cold Spring Harbor Laboratory (CSHL) have found that CA19-9 may actually promote the development of these pancreatic diseases and that blocking CA19-9 could serve as a therapeutic strategy. An antibody drug targeting CA19-9, MVT-5873, is in clinical testing for pancreatic cancer and was acquired by German biotech BioNTech.
Bio-Techne’s urine test, ExoDx Prostate IntelliScore test, tracks down the exosomes and genomic markers released from prostate cancer cells. It is the first liquid biopsy to receive breakthrough status from the FDA for targeting exosomes. The aim of the test is to rule out unnecessary tissue biopsies following the results of a prostate-specific antigen (PSA) test, which can give false positive results.
Abbott launched its new point-of-care diabetes blood test, the Afinion HbA1c Dx test. It can provide hemoglobin A1c results in 3 minutes, allowing clinicians to develop and start care plans within a patient’s single visit to the doctor’s office.
The FDA, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services in the USA have formed an interagency task force with the goal of facilitating rapid development and deployment of in vitro diagnostic tests during public health emergencies.
Sight Diagnostics received the CE Mark last year for its OLO system, which uses digital microscopy to visually analyze cell types by size, shape, count and morphology, from a few drops of blood during a single office visit. The technology has been used to screen over 600,000 samples for malaria infections and will now be adding complete blood count testing to its system. Sight Diagnostics has raised US$27.8 million to continue its global commercial expansion, fund regulatory efforts and support its research and development.
Magnolia Medical Technologies’ Steripath Gen2 Initial Specimen Diversion Device aims to reduce sample contamination during patient blood draws, which lead to inaccurate laboratory test results. The company has raised US$20 million in venture capital funding to help scale up production.