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In Brief This Week: SARS-CoV-2 Testing, MGI, Angle, and More

NEW YORK – 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.

MGI Tech, the instrument division of China's BGI Group, recently closed a $1 billion Series B financing round. 

IDG Capital and Citic Private Equity Funds Management led the round, joined by new investors Huaxing Growth Capital Fund, Guofang Investment, Huatai Zijin Investment, TI Capital, Sailing Capital, Co-stone Capital, Dingfeng Asset, GuotaiJunan Securities as well as existing investors Jinshi Investment and Songhe Capital.

The funding adds to $200 million the firm raised in its 2019 Series A financing round. MGI did not say how it plans to use the new funds.

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.

Clinical-stage biopharmaceutical company Enterome said this week that it has completed a new financing totaling €46.3 million ($52.6 million)As part of this financing, Enterome closed a Series E round with new investors, including microbiome-focused investment vehicle SymBiosis and Takeda Pharmaceutical. Existing Enterome investors Seventure, Health for Life Capital, Principia, Omnes Capital, and Nestlé Health Science also participated in the round. In addition, the company made a first drawdown from a loan facility provided by the European Investment Bank under a 2018 agreement.

The firm said it will use the funds to continue the development of its therapeutic pipeline, including the first clinical trials of EO2401, a novel OncoMimic cancer immunotherapy. The two Phase 1/2 clinical studies in glioblastoma and adrenal tumors, respectively, will start in mid-2020. OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells.

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.

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 platform for the secure collection of biological data.

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 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.

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.

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 GenomeWeb.