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In Brief This Week: Natera, Genome Diagnostics, Veracyte, and More

NEW YORK (GenomeWeb) – Natera said this week that the US Food and Drug Administration has granted breakthrough device designation for its circulating tumor DNA test, which is currently available for research. The ctDNA test, Signatera, is a bespoke assay that analyzes a handful of mutations in a patient's tumor identified through tumor biopsy and sequencing. The FDA granted the designation for Signatera for use in patients previously diagnosed with certain cancer types and in combination with certain drugs.

Natera plans to launch a clinical version of the test in the second quarter. The assay will initially be available for minimal residual disease testing and monitoring for disease recurrence.

Dutch molecular diagnostics firm Genome Diagnostics said this week that Ampersand Capital Partners has invested in and become a minority shareholder in the company. GenDx CEO Wietse Mulder declined to disclose the amount of the investment but said that the company's founders sold their shares to Ampersand. He will remain the company's majority shareholder. GenDx will work closely with Ampersand to grow the company organically and through M&A, Mulder added.

Veracyte said this week that it raised $137.9 million in net proceeds in a public offering that closed on Tuesday. It sold more than 6.3 million shares of common stock, including 825,000 shares sold upon the full exercise of the underwriters’ option to purchase additional shares, at $23.25 per share.

The company filed a shelf registration for the public offering on May 2, and previously said that it intends to use the net proceeds for working capital, other general corporate purposes, and to repay around $12.4 million of its term loan.

Morgan Stanley & Co. and SVB Leerink acted as lead book-running managers for the offering. William Blair was the book-running manager and BTIG and Janney Montgomery Scott acted as co-managers.

Investment bank UBS this week upgraded its rating for Bruker to Neutral, after the company posted a 7 percent increase in first quarter revenues.

In addition, the company raised its revenue guidance for 2019. "While this new guide sets a higher bar (given recent trend of more conservative guides), given improving momentum, a pipeline of new products and better execution, we see new guidance as reasonable with room for upside (pipeline dependent)," UBS said. "These positives are balanced against a higher valuation (post strong performance) and risks (EU exposure, instrument orientation, historical volatility), hence we see Neutral as appropriate."

Forensic genomics firm Verogen said this week that it has signed a collaboration agreement with UK-based Cellmark Forensic Services. Verogen installed its next-generation sequencing-based MiSeq FGx platform at Cellmark’s Abingdon, UK laboratory in February and Cellmark is working to validate the technology in anticipation of seeking accreditation by the UK Accreditation Service.

Dyadic International said this week that it has sublicensed its proprietary C1 gene expression platform to Alphazyme, a biotechnology company that produces molecular biology enzymes. The agreement includes an equity stake as well as milestone payments and royalties upon the commercialization of C1-expressed Alphazyme products.

Roche Diagnostics said this week that it has expanded its partnership with Bio-Techne by offering new chromogenic detection kits for automated in situ hybridization (ISH) tissue analysis for drug discovery researchers in the US.

The Roche kits include its Discovery mRNA Purple HRP detection kit (RUO) and the Discovery mRNA Teal HRP detection kit (RUO). The purple and teal detection kits feature translucent dyes for co-localization studies for mRNA ISH and the ability to perform IHC and ISH for protein-RNA co-detection on the same slide, Roche said. Both kits are designed to be used on the Roche Discovery Ultra staining platform with the Bio-Techne Advanced Cell Diagnostics RNAscope Vs Universal HRP Reagent Kit.

Further, Roche's mRNA Duplex AMP kit (RUO) has an expanded application that enables the new mRNA Teal HRP detection kit to be used with Roche's existing mRNA Red detection kit (RUO) for dual mRNA ISH detection. The expanded application is intended to be used with Bio-Techne's RNAscope Vs Duplex Reagent Kit, which delivers simultaneous in situ detection of two mRNA species.

VolitionRx reported in a document filed with the US Securities and Exchange Commission that its net loss for the first quarter narrowed to $4.2 million, or $.12 per share, from $4.7 million, or $.17 per share, in Q1 2018.

Its R&D costs grew 4 percent to $2.5 million from $2.4 million a year ago, while its SG&A costs contracted 32 percent to $1.5 million $2.2 million.

The firm recorded no revenues for the recently completed quarter, the same as a year ago. It exited the quarter with $16.2 million in cash and cash equivalents.

Separately, the company said it has executed a contract under a memorandum of understanding to conduct a large-scale lung cancer study with National University Taiwan. The study, being led by Chen Jin-Shing, a professor in the department of surgery at the university, will include 1,200 subjects receiving low-dose computed tomography scans, including 1,000 patients with lung cancer. The company said the study will cost about $320,000 over two years and preliminary data for the first 600 patient samples is expected to be released in Q1 2020.

Singapore-based iGene Laboratory said this week it has signed a joint venture deal with Klinik Fertilitas Bocah Indonesia to establish PT Nexgen Diagnostika in Jakarta, Indonesia, which will provide molecular diagnostic testing in women's and reproductive health.

Celcuity this week reported that its net loss for the first quarter of 2019 narrowed to $1.9 million, or $.18 per share, from $2.0 million, or $.19 per share, in Q1 2018. On an adjusted basis, Celcuity had a net loss of $.16 per share for the recently completed quarter.

Celcuity's R&D costs rose 7 percent year over year to $1.6 million from $1.5 million, while its general and administrative costs dropped 28 percent to $383,545 from $530,640.

The company finished the quarter with cash, cash equivalents, and investments of $23.4 million.

The firm went public in 2017. It reported no revenue during the recent quarter.

Celcuity Chairman and CEO Brian Sullivan said in a statement that the firm began adding new clinical sites in late 2018 to accelerate enrollment in the FACT 1 trial, which is evaluating the safety and efficacy of Genentech drugs Herceptin and Perjeta combined with chemotherapy in early stage breast cancer patients selected with Celcuity’s CELx HSF functional cellular analysis test.

Sullivan said that a FACT 2 clinical trial was launched in early April and will evaluate Puma Biotechnology's targeted therapy, Nerlynx, in patients selected by the CELx HSF test. Celcuity said it expects interim results from the trial in late 2019 or early 2020 and final results about 12 months later.

A trial to evaluate tissue samples from a Phase II study evaluating Puma's pan-HER inhibitor, Nerlynx, Genentech's HER2 antibody, Herceptin, and Bristol-Myers Squibb’s EGFR inhibitor, Erbitux, in metastatic colorectal cancer patients also continues to progress, Sullivan added.

Danaher this week said its board approved a regular quarterly cash dividend of $.17 per share, payable on July 26 to shareholders on record on June 28. The board also approved a quarterly cash dividend of $17.68 per share for its 4.75 percent Series A mandatory convertible preferred stock, payable on July 15 to shareholders on record on June 30.

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.