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In Brief This Week: Illumina, Thermo Fisher, Tempus, Bionano Genomics, Danaher, More

NEW YORK – Illumina said this week that it has opened a new office and solutions center in Bengaluru, India. The facility features a fully equipped lab with Illumina's latest next-generation sequencing and microarray technologies, as well as field application and service staff. In a statement, Illumina said it will "continue to collaborate" with Premas Life Sciences, the firm's Indian distributor.

Thermo Fisher Scientific said this week that it will lay off 205 employees at the company’s Alachua, Florida, facility. According to a Worker Adjustment and Retraining Notification (WARN) notice that Thermo Fisher filed with the Florida Department of Commerce, the first separation is expected to occur on Oct. 9 and may continue through March 29, 2024.

Tempus said this week that the US Food and Drug Administration has granted the firm's HLA-LOH assay breakthrough device designation as a companion diagnostic test. Leveraging a machine learning model, the test analyzes sequencing data produced by Tempus' xT CDx assay. The HLA-LOH assay is for identifying cancer patients with solid tumors who may benefit from treatment with specific targeted therapies when the tumor has allele-specific loss of heterozygosity for specific human leukocyte antigen Class I alleles, the Chicago-based company said.

Bionano Laboratories, a clinical laboratory service division of Bionano Genomics, has received College of American Pathologists (CAP) accreditation for its clinical lab this week. Bionano President and CEO Erik Holmlin said in a statement that he believes the CAP accreditation will help the firm to "support the proliferation of optical genome mapping (OGM) in a number of markets, including the cell and gene therapy markets."

Danaher this week replaced its existing $5.0 billion unsecured, multiyear revolving credit facility with a third amended and restated $5.0 billion unsecured, multiyear revolving credit facility, according to documents filed with the US Securities and Exchange Commission. The credit facility expires on Aug. 11, 2028, and is subject to a one-year extension option at the request of Danaher and with the approval of the lenders. It also contains an expansion option allowing Danaher to request up to five increases of up to an aggregate additional $2.5 billion, upon the satisfaction of certain conditions. Bank of America is the administrative agent of the credit facility, Danaher noted.

Lucid Diagnostics this week reported its second quarter test volume rose 159 percent year over year to 2,202 EsoGuard Esophageal DNA cancer tests and the firm narrowed its net losses compared to Q2 2022. The New York-based firm reported revenues of $159,000 for the three months ended June 30 compared to no revenues in the second quarter of 2022. Though the firm performed 850 tests in the year-ago quarter, it didn't collect revenues due to an extended transition period involving opening a new lab and onboarding a revenue cycle management partner. The company reported a net loss of $11.4 million for the second quarter of 2023, or $.27 per share, compared to a loss of $14.6 million, or $.41 per share, a year earlier. On an adjusted basis, LucidDx recorded a loss of $.23 per share. The firm cut its R&D spending by 47 percent in the quarter, to $1.8 million from $3.4 million in Q2 2022, and reduced its general and administrative spending by 43 percent, to $3.8 million from $6.7 million. The firm's sales and marketing spending was up about 3 percent, to $4.0 million from $3.9 million. It finished the quarter with $32.6 million in cash and cash equivalents.

Lucid Chairman and CEO Lishan Aklog said in a statement, "Lucid closed out a strong first half of 2023, with yet another quarter of double-digit EsoGuard test volume growth and major accomplishments on multiple strategic fronts, which we believe will drive substantial value in the coming quarters."

Biocept this week said that lower RT-PCR COVID-19 testing volume resulted in a drop in its second quarter revenues to $589,000 from $5.8 million a year ago. The San Diego-based developer of molecular diagnostic tests for cancer had previously said it stopped providing COVID-19 testing services in February. It reported this week that the number of commercial accessions delivered during the three months ended June 30 dropped to 322 from 77,779 a year ago. Biocept recorded a net loss of $3.6 million, or $3.50 per share, in the recently completed quarter compared to a net loss of $10.0 million, or $17.82 per share, a year ago. It used 1,036,529 shares to calculate the loss per share figure for Q2 2023 compared to 563,528 shares in Q2 2022. In May, the firm executed a 1-for-30 reverse stock split. The same month it announced a $5 million public offering of its common stock and warrants to purchase shares of its common stock.

In Q2 2023, Biocept slashed its R&D spending to $409,000 from $1.7 million in Q2 2022. It reduced its SG&A spending to $3.7 million from $6.0 million.

The company exited the second quarter with $6.6 million in cash and cash equivalents.

Mainz Biomed said this week that its revenues for the second quarter of 2023 grew more than 100 percent compared to the same period of 2022 as it accelerated development of its colorectal cancer screening test. The company reported $248,945 in revenues, up from $139,240 in Q2 last year. The firm spent $3.5 million on R&D during the quarter, dwarfing the $229,916 reported for the same period of 2022. Its SG&A costs were down, meanwhile, at $4.6 million compared to $6.8 million. The company said that the increased R&D expenses were planned and reflect the continued development of its next-generation colorectal cancer screening test and increased costs related to the peak enrollment in its eAArly Detect and ColoFuture studies. Mainz's net loss for the quarter was $8.3 million, or $.56 per share, compared to $6.9 million, or $.48 per share, in Q2 2022. The firm ended the period with $10.9 million in cash.

Sherlock Biosciences this week opened a biomanufacturing facility in Cambridge, UK. The purpose-built, ISO 13485-certified 36,000-square-foot facility will support production of 5 million diagnostic devices, with capacity to grow as the company approaches commercialization.

Proteome Sciences is expanding its contract research services into the US with the opening of a new facility in San Diego, the firm said this week. The UK-based firm said the new subsidiary, Proteome Sciences US, is expected to be fully operational by the end of the third quarter this year. The firm will offer biopharma and academic customers across the US, and in particular research hubs on the west coast, outsourced proteomics services. "We plan to enable this facility to offer all our current mass spec-based proteomic services and our soon to be launched service to sequence the proteome from a single cell," the firm said in an email.

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.