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In Brief This Week: Agilent, Co-Diagnostics, Bio-Techne, and More

NEW YORK (GenomeWeb) – Agilent Technologies said this week that its PD-L1 IHC 22C3 pharmDx assay has been labeled for an updated use in urothelial carcinoma in Europe. Doctors there can now use the assay to identify urothelial carcinoma patients who are ineligible for cisplatin but may respond to the Merck immunotherapy Keytruda as a first-line treatment option.

The assay, developed by Agilent subsidiary Dako, was CE marked in 2016 as a companion diagnostic to identify best responders to Keytruda for lung cancer. In 2017 it received expanded CE marking as a CDx for Keytruda for use with patients with metastatic non-small cell lung cancer with no EGFR or ALK mutations and who have not yet been treated.

The test is also US Food and Drug Administration-approved as a CDx for Keytruda for gastric and cervical cancer indications.

Co-Diagnostics said this week it has closed a non-convertible debt instrument for $2 million. The firm will use the funds for working capital, to expand distribution of its infectious disease testing products, and to accelerate initiatives to develop multiplex screens for liquid biopsy cancer screening, blood-bank screening, and SNP detection with applications in several areas.

In a separate document filed with the US Securities and Exchange Commission, Co-Diagnostics said that it entered into the note purchase agreement with Robert Salna, an existing shareholder, whereby the company issued him a promissory note in the amount of $2 million in exchange for a loan to the company for the same amount. The note bears interest at the rate of 9 percent per year, payable quarterly in arrears.

Bio-Techne's board this week approved a dividend of $.32 per share to be paid on Aug. 31 to shareholders of record on Aug. 17.

HTG Molecular Diagnostics announced this week that it has amended its assay development, commercialization, and manufacturing agreement with Qiagen Manchester in relation to a project the two companies are collaborating on for what is expected to be a multi-stage project leading to the potential development and commercialization of an NGS-based companion diagnostic assay in support of one or more of the therapeutic development and commercialization programs of Bristol-Myers Squibb. Initial-phase development activities under the agreement between HTG and Qiagen Manchester are complete, but the amendment relates to the next phase which includes the use of the research-use-only assay in a retrospective clinical trial, the partners said.

Toolbox Medical Innovations said this week that it has expanded into a new facility in Carlsbad, California with more than 18,000 square feet. The new space will allow the in vitro diagnostic contract research organization to expand its usability testing lab, and prototyping and manufacturing capabilities. It will also add two custom-built, state-of-the-art testing labs, equipped with four ultra-HD cameras that can capture the smallest detail of user interaction, as well as an observation suite for customers to observe users utilizing their products.

Celcuity this week reported a net loss for the second quarter of slightly more than $1.8 million, or $.18 per share, compared to a net loss of slightly less than $1.8 million, or $.28 per share, in Q2 2017. On a non-GAAP basis, its net loss for the recently completed quarter was $.15 per share. The firm used 10.1 million shares to calculate its per-share loss in the recently completed quarter compared to 6.4 million shares in the year-ago period. Celcuity went public in September 2017.

Its R&D spending increased 15 percent to $1.5 million from $1.3 million in the year-ago period, while its general and administrative costs grew 19 percent to $1.9 million from $1.6 million.

Celcuity did not report any revenues.

The company finished the quarter with $3.2 million in cash and cash equivalents and $18.4 million in investments.

Celcuity Chairman and CEO Brian Sullivan said in a statement that the firm continues to develop the CELx Signaling Function tests for breast cancer and two new tissue types. "In breast cancer, we are evaluating new signaling pathways to add to our current CELx MP Signaling Function test for breast cancer," which analyzes HER1/2/3 and c-Met signaling activity, he said. It also diagnoses untreated cell signaling dysfunction in about 25 percent of HER2-negative breast cancer patients.

"We believe there is an opportunity to increase the total percentage of HER2-negative breast cancer patients diagnosed with untreated signaling dysfunction to 35 percent to 45 percent," Sullivan added.

Celcuity also aims to develop CELx tests for new tumor types and is advancing its cell microenvironment technology to expanding its capability to evaluate different types of signaling dysfunction .

The company previous disclosed a collaboration with Genentech and the NSABP Foundation to assess the efficacy of two Genentech HER2 drugs, Herceptin and Perjeta, in HER2-negative breast cancer patients selected by Celcuity's CELx HER2 Signaling Function test. Sullivan said this week that the clinical trial is progressing, and Celcuity continues to expect interim results from the trial in mid-2019.

A Phase II study assessing Herceptin, Puma Biotechnology pan-HER inhibitor, Nerlyn, and Bristol Myers Squibb's EGFR inhibitor, Erbitux, in metastatic colorectal cancer is also progressing, Sullivan added.

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.