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In Brief This Week: BioDirection, Quest Diagnostics, OncoCyte, and More

NEW YORK (360Dx) – BioDirection said this week that its Tbit System for traumatic brain injury has received breakthrough device designation from the US Food and Drug Administration. The technology detects and measures protein biomarkers released from the brain immediately after head trauma and is meant to predict positive computerized tomography scans after such injuries. The system allows testing to be done initially in the emergency department and — if cleared by the FDA — at the point of injury, according to the company. Tbit is being developed to provide results in less than two minutes from a drop of blood.

Quest Diagnostics announced this week that is has completed its previously announced acquisition of the clinical lab services assets of Boyce and Bynum Pathology Laboratories (BBPL). Through a separate professional services agreement, Boyce and Bynum Pathology Professional Services is now the exclusive pathology provider for Quest clients in Missouri, and a preferred pathology provider in the greater Midwest. The goal of the acquisition was to bring a broader menu of clinical laboratory and pathology services to patients throughout the region. Financial terms of the transaction were not disclosed.

OncoCyte said this week that it closed its underwritten public offering, raising aggregate gross proceeds of nearly $40.3 million. Following the exercise in full by the underwriters of their option to purchase up to an additional 1.4 million shares of common stock at the public offering price, the company sold 10.7 million shares at a public offering price of $3.75 per share.

The firm intends to use the proceeds to support commercialization of its DetermaVu test, including new clinical studies to support reimbursement and adoption, and to finance future product development.

SpeeDx said this week that it has submitted its PlexPCR RespiVirus test to the Therapeutic Goods Administration of Australia. The company anticipates clearance of the test in time for the 2019 Australian flu season, which usually peaks around August. SpeeDx's PlexPCR technology enables multiplex detection of 14 targets representing 10 viral respiratory illness-causing pathogens, including influenza A, influenza B, rhinoviruses (A and B), respiratory syncytial viruses (A and B), human metapneumovirus, adenoviruses, and human parainfluenza viruses 1, 2, 3, and 4.

Translational Software, PWN Health, and Allscripts Healthcare solutions subsidiary 2bPrecise said this week that they have launched an automated portal to provide free pharmacogenomic testing to all US-based Allscripts associates. The new program is run on a user-friendly portal built by Translational Software, where associates can place an order. PWN approves the order and sends out a testing kit. Once the kit is returned by the associate, it is routed to a testing laboratory in the Translational Software network selected by Allscripts. The laboratory performs the test and sends the interpreted results back to the portal, where they are accessible by the associate. If an associate is interested in counseling on how to interpret their results, PWN offers telehealth sessions with a healthcare professional.

Swedish diagnostics firm Immunovia said this week that its 2018 fourth quarter sales rose to SEK 91,000 ($9,800) from SEK 26,000 in Q4 2017. Its net loss for the recently completed quarter widened to SEK 25.7 million, or SEK 1.31 per share, from a net loss of SEK 15.3 million, or SEK .88 per share, a year ago.

For full-year 2018, Immunovia reported net sales of SEK 333,000, up from SEK 149,000 in 2017. Its net loss for the year was SEK 86.5 millon, or SEK 4.67 per share, compared to a net loss of SEK 45.2 million, or SEK 2.67 per share, a year ago.

The company said that it expects first revenues from self-pay sales to begin in the latter part of 2019, and it has a sales target of SEK 250 million to SEK 300 million by 2022 based on self-pay sales of its IMMray PanCan-d test. Longer term, its target is total sales of SEK 800 million to SEK 1 billion by 2024.

Circulogene announced this week that its molecular diagnostic laboratory has been accredited by the College of American Pathologists following an onsite inspection. The lab received CLIA certification in 2015, the company said. Circulogene's proprietary technology platform provides genomic testing services to aid oncologists and pathologists select appropriate clinical trials and the most effective cancer therapies for their patients. The platform can also be used to monitor patient responses, drug resistance, minimal residual disease, and relapse.

Fujirebio Diagnostics said this week it received breakthrough device designation from the Center of Devices and Radiological Health of the US Food and Drug Administration for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test. The test is to aid clinicians in assessing patients 50 or older, who present with cognitive impairment and are being evaluated for Alzheimer's disease and other causes of cognitive decline. It measures β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebrospinal fluids and combines them into a numerical ratio of β-amyloid 1-42/β-amyloid 1-40 to estimate the presence of β-amyloid neuritic plaque pathology in the brain.

Precipio said this week that it anticipates reporting $2.8 million in preliminary revenues for 2018, up 65 percent from $1.7 million in 2017.

 The firm said it expects that its fourth quarter preliminary revenues increased about 6 percent over the prior-year quarter, and its Q4 quarter-over-quarter cash expenses dropped to $2.4 million from $3.1 million.

Precipio said that it anticipates growth driven by revenue increases from its pathology business and pharma projects, and by revenue from recently developed and launched products — its HemeScreen panel used to analyzed hematologic malignancies and its IV-Cell cytogenetics media.

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.