NEW YORK – SkylineDx said this week that it has inked a 10th collaboration agreement with an academic partner under its Falcon R&D Program to enable further validation of its Merlin and Peregrine melanoma tests. The collaboration with 10 clinical centers, located in six countries, will allow SkylineDx to use data from more than 3,500 patients with cutaneous melanoma, the firm said.
Patients without metastasis in sentinel lymph nodes are considered low risk, but a significant number of them experience a recurrence of melanoma within five years, SkylineDx said. Its Merlin test predicts a patient’s risk of having metastasis in the sentinel lymph node, and its Peregrine assay identifies patients at high risk of disease recurrence within the group of patients currently considered low risk so that treatment options can be discussed.
Biocept said this week that it has entered into a managed care provider agreement with reference-based pricing insurance network Medical Cost Containment Professionals. Under the terms of the agreement, MCCP, which includes more than 150,000 providers nationwide, will process out-of-network claims for Biocept's Target Selector liquid biopsy testing at pre-negotiated prices and in a timely manner. This will help to accelerate collections while reducing the length of time that receivables remain outstanding, the company said, noting that it is working to set up similar partnerships with other insurance networks, as well as deals with managed-care plans for in-network coverage for their members.
Liquid biopsy firm Angle this week released preliminary results for the eight months ending Dec. 31, 2019. The UK-based company is switching to a calendar year schedule for reporting its financial results instead of the previous fiscal year calendar ending on April 30. For the eight-month period, Angle posted £600,000 ($744,000) in revenues and a loss of £6.2 million, which reflected planned investments. More than 20,000 samples were processed during the period, it said. The company had a cash balance of £18.8 million at the end of 2019. Highlights included progress in multiyear clinical and analytical studies in support of a De Novo submission to the US Food and Drug Administration for the Parsortix system.
Torrance, California-based Neoteryx said this week that its Mitra microsampling device for blood collection has been registered as a Class I in vitro diagnostic device with the Therapeutic Goods Administration in Australia. Neoteryx's device enables the collection of blood at home by a finger stick. The device is based on microsampling technology that enables a precise volume of blood to be collected on an absorbent tip. Doctors, researchers, and labs in Australia can send Mitra devices and blood collection kits to patients or clinical trial participants who must stay at home or who live in remote areas, Neoteryx said.
The US Department of Labor, Department of Treasury, and Department of Health and Human Services released joint guidance this week on coverage and payment requirements for SARS-CoV-2 testing under the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act. Under the guidance, insurers must provide coverage and reimbursement without cost-sharing, prior authorization, or other medical management for in vitro diagnostic tests that have received Emergency Use Authorization from the US Food and Drug Administration, or for tests from laboratories that have validated their assays and intend to request EUA. Coverage is also required for tests developed and authorized in states that have notified HHS of their intentions to review COVID-19 diagnostic tests.
However, testing for surveillance or employment purposes, such as to conduct screenings for general workplace health and safety or for public-health surveillance, is not required to be covered. In response to the guidance, the American Clinical Laboratory Association released a statement requesting that Congress provide federal funding to close the coverage gap, so laboratories do not have to absorb the costs of this testing.
FlowMetric Life Sciences said this week that Pennsylvania has certified the company’s lab as a high-complexity lab under the CLIA Laboratory Improvement Amendments of 1988 after the firm demonstrated that the lab met state and federal regulations for clinical diagnostic testing. The Doylestown, Pennsylvania-based firm said that receiving CLIA certification allows it to immediately provide testing to individuals who may have been exposed to SARS-CoV-2. FlowMetric offers cell-based and SARS-CoV-2 serology testing and flow cytometry-based approaches for drug development.
British laboratory workflow software developer Dotmatics said this week that it has acquired BioBright, a maker of scientific lab data automation tools. Terms of the deal were not disclosed.
Dotmatics called the acquisition complementary, allowing it to offer lab-data capture, data processing, electronic-lab notebooks, and artificial intelligence-driven data analytics on a single, cloud-based platform. Boston-based BioBright, which was founded in 2015, benefitted from early funding from the US Defense Advanced Research Projects Agency to build a platform for the secure collection of biological data.
Natera said this week that it has expanded its lab facility in Austin, Texas. The larger, 70,000-square-foot facility has additional lab capacity and automated equipment, and will reduce the cost-of-goods sold, the company said.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.