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In Brief This Week: Thermo Fisher Scientific, Curetis, OpGen, and More

NEW YORK – Thermo Fisher Scientific disclosed in a regulatory filing this week that it paid an aggregate purchase price of $14 million for HighChem, a Slovakia-based provider of mass spectrometry software for the identification of compounds that the company acquired in June. HighChem became part of Thermo Fisher's chromatography and mass spectrometry business, in its analytical instruments unit.

Curetis said this week that its wholly owned subsidiary Ares Genetics launched an early access program for its AI-powered next-generation sequencing-based molecular antibiotic susceptibility test. The ARESupa-Universal Pathogenome Assay molecular AST is an expanded version of the NGS-based ARESupa test and is for identifying pathogens and resistance genes. The test can accurately predict antibiotic susceptibility, leveraging AI-based interpretation of high-throughput DNA sequencing data, Curetis said.

Commercial orders for ARESupa tests have exceeded 1,000, and as a result of the early access program, broader commercialization of the test is expected to begin in early 2020. It will initially be offered for non-diagnostics applications in epidemiology, infection control, and outbreak analysis for customers in the public health sector and the pharmaceutical industry, Curetis added. The company is also planning a laboratory-developed test for use on native patient samples for human diagnostics in indications when culture-based methods pose challenges.

Ares Genetics also recently entered into a multiphase partnership with an undisclosed global in vitro diagnostics firm to jointly develop diagnostic solutions for infectious diseases, based on ARESupa, Curetis said.

OpGen said this week that it has closed its previously disclosed public offering of securities, raising gross proceeds of about $9.4 million. The company offered about 2.6 million units at $2 per unit and 2.1 million prefunded units at $1.99 per prefunded unit. OpGen has granted HC Wainwright, the sole book-running agent for offering, a 30-day option to purchase up to an additional 705,000 shares of common stock and/or common warrants to purchase up to 705,000 shares of common stock. 

OpGen said it will primarily use the proceeds of the offering to complete its acquisition of German molecular diagnostics firm Curetis, provide short-term funding to Curetis, and support the ongoing submission of its Acuitas AMR Gene Panel and its Acuitas Lighthouse software for antibiotic resistance detection to US regulators. Funds may also be used to commercialize products from the OpGen/Curetis combined company, for R&D, and general corporate purposes.

Oncimmune said this week that it expects to report a 29 percent drop in fiscal 2019 revenues.

For the 12-months ending May 31, the firm's unaudited preliminary revenues fell to £171,000 ($221.290) from £240,000 in fiscal 2018.

Oncimmune reported a net loss of £8 million, or 12.97 pence per share, compared to £6.4 million, or 11.41 pence per share, in fiscal 2018.

The firm said that its preliminary R&D expenses rose 88 percent year over year to £1.5 million from £800,000, and its administrative expenses rose 23 percent to £5.9 million from £4.8 million in the prior year.

Oncimmune expects to report cash and cash equivalents at the end of the fiscal year of £5.4 million.

The company is developing a proteomic assay, EarlyCDT-Lung, to identify at-risk individuals who have developed or are beginning to develop lung cancer.

The firm said that among its highlights for the quarter, it published positive top line results for the Early detection of Cancer of the Lung Scotland trial, ECLS, a randomized controlled study using blood biomarkers for the detection of lung cancer with 12,209 patients.

Oncimmune also announced this week that it has completed a commercialization agreement with Biodesix for EarlyCDT Lung in the US, which was first announced in June. Under the terms of the commercialization agreement, Biodesix completed the acquisition of Oncimmune's CLIA laboratory facilities in Kansas, and will pay $1.0 million to Oncimmune in quarterly instalments of $250,000.

Oncimmune has granted Biodesix an option to commercialize EarlyCDT Lung as a screening diagnostic for lung cancer in the US in exchange for a further cash payment. The option is exercisable by the end of 2020. This strategic commercialization agreement represents value to Oncimmune of up to $28 million up to Nov. 1, 2024, Oncimmune said. The agreement can be renewed by Biodesix for a further five years.

Oncimmune also said it will continue to collaborate with Biodesix on research and development activities in order to fully leverage the commercial potential of EarlyCDT Lung in the US.

The companies also signed a profitable supply agreement this week under which Oncimmune will provide Biodesix with diagnostic plates and associated reagents.

Caris Life Sciences announced this week that St. Joseph Hospital has become the 30th member of its Precision Oncology Alliance. The alliance is a collaborative network of cancer centers working together to advance tumor profiling and establish standards of care for molecular testing in oncology.

The Center for Cancer Prevention and Treatment at St. Joseph Hospital offers access to prevention, diagnosis, treatment, and clinical trials. Through the Precision Oncology Alliance, St. Joseph Hospital will partner with other cancer centers and academic institutions to broaden patient access to precision cancer care, validate Caris' Next Generation Profiling offerings, and establish evidence-based standards for tumor profiling and molecular testing in oncology.

Rare disease diagnostics company Centogene said this week that it plans to offer 4 million shares of its common stock at $14 to $16 per share. In addition, the underwriters will have a 30-day option to purchase an additional 600,000 shares at the IPO price. Centogene expects to raise approximately $60 million at the midpoint of the offering. The company, based in Rostock, Germany, plans to trade on the Nasdaq under the symbol CNTG. As an emerging growth company and a foreign private issuer, the firm will be subject to reduced public company reporting requirements. SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering, and Baird and BTIG as co-managers. Centogene had first filed a preliminary prospectus to go public with the US Securities and Exchange Commission in October.

London-based business standards group BSI said this week that it was notified on Oct. 26 that its UK notified body has been designated as such for overseeing compliance with the new In Vitro Diagnostic Regulation, taking effect in May 2022. Until this month, no firm had been designated an NB under IVDR, though some firms had been designated NBs for the Medical Device Regulation, which will take effect in May 2020. Berlin-based Dekra was the first designated NB for IVDR.

Owlstone Medical said this week that it has joined 3TR, a large-scale public-private research initiative that aims to provide insights into the mechanisms of response and non-response to treatment within and across seven different immune-mediated diseases. Owlstone will receive funds to provide Breath Biopsy collection stations and kits for the collection of breath samples, and to provide analysis services for multiple studies that have been identified as suitable to include breath sampling alongside clinical and physiological evaluation and blood analysis.

Owlstone said that it will receive funding to provide the breath component of a multi-dimensional molecular analysis of patient samples, with an initial focus on asthma and chronic obstructive pulmonary disease.

3TR has been funded with more than €80 million ($88.8 million) over the next seven years by Innovative Medicine Initiative 2 — a joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations.

The Foundation for Innovative New Diagnostics this week announced a collaboration with India's Revised National Tuberculosis Control Programme in its effort to eradicate tuberculosis in that country. RNTCP established the National Strategic Plan with a goal to eliminate TB in India by 2025. FIND will work with state-level officials to establish and improve the capacity of culture and drug-susceptibility testing facilities in the high-burden TB states of Maharashtra, Himanchal Pradesh, and Tamil Nadu. With support from Johnson & Johnson, FIND said it will provide technical assistance, and develop a comprehensive guidance document for capacity building to ensure that labs are sustained long term, with knowledge transfer to the RNTCP. As a result, states with the funds to do so will be able to build labs at an accelerated pace, FIND added.

Kobe University, the city of Kobe, the Foundation for Biomedical Research and Innovation at Kobe, and Sysmex announced this week the creation of the BioResource Innovation Hub in Kobe to promote the use of bioresources. Earlier this year, Kobe University established the BioResource Center, a clinical biobank enabling researchers and R&D companies to access bioresources easily. The center was created to enable "advances in preemptive medicine and personalized medicine, such as early-stage diagnosis of disease, prediction of therapeutic efficacy, the search for biomarkers effective at diagnosing recurrence risk, and innovative drug discovery," the partners said in a statement.

The Innovation Hub will share R&D needs related to new treatment and diagnostic methods obtained in market surveys by pharmaceutical companies and R&D institutions with the BioResource Center. The Innovation Hub's goal is to accumulate bioresources with high R&D value and provide a framework for using those resources, keeping personal information protection and other ethical concerns in the forefront.

First Light Diagnostics said this week that it is participating in the US Centers for Disease Control and Prevention's Antimicrobial Resistance Challenge. The initiative was launched in late 2018 and involves government entities, private companies, and non-governmental organizations who have made commitments against antimicrobial resistance. More than 300 organizations have made such a commitment, First Light said. As part of its participation in the initiative, First Light will use its MultiPath platform to eliminate the unnecessary use and overuse of antibiotics. The company has begun deploying the platform at customer clinical study sites and is targeting clearance by the US Food and Drug Administration in 2020.

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.