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In Brief This Week: Fluidigm, Thermo Fisher Scientific, Veracyte, and More

NEW YORK – Fluidigm shareholders filed a lawsuit this week against the company in the US District Court for the Northern District of California for allegedly violating federal securities laws in connection with Fluidigm's second quarter 2019 financial results. Plaintiff Reena Saintjermain, individually and on behalf of other shareholders who acquired Fluidigm stock between Feb. 7, 2019 and Nov. 5, 2019, alleges in the complaint that throughout the stated period, Fluidigm executives made "materially false and misleading statements, as well as failed to disclose material adverse facts" about its business.

On Aug. 1, 2019, Fluidigm reported Q2 2019 revenue of $28.2 million, well below analysts' expectations of $32 million, citing weakness in its microfluidics segment, and causing the company's share price to drop precipitously. The complaint also alleges that on Nov. 5, Fluidigm reported an 8.5 percent year-over-year decline in Q3 revenues due to lower mass cytometry instrument sales, again causing the company's stock to fall.

The plaintiff and other class members suffered "significant losses and damages," according to the complaint, and are seeking compensatory damages and all costs and expenses related to the lawsuit.

Thermo Fisher Scientific said this week that it has launched a grant program to support clinical research projects in oncology and reproductive health. The Oncomine Clinical Research Grant Program — which will initially focus on oncology — will make four awards, each worth up to $200,000 in reagents and funding, and will include the opportunity to work with the Ion Torrent Genexus sequencing system for the duration of the project. The company is accepting grant proposals dedicated to gene fusions in solid tumors and molecular testing in blood cancers from independent clinical research teams between now and Oct. 31.

Thermo Fisher Scientific also said this week that it has expanded its The Just Project to include Tuskegee University as a testing center. The project, which was launched last month, provides free COVID-19 testing to students and faculty on campuses of Historically Black Colleges and Universities (HBCUs). Thermo Fisher is funding the initiative with $25 million for diagnostic instruments, test kits, supplies, and technical support to establish or expand laboratories for COVID-19 testing. Tuskegee University will set up a CLIA-certified lab for testing samples for up to 15 HBCUs across Alabama and Mississippi.

Veracyte said this week that the Centers for Medicare and Medicaid Services (CMS) has approved new Advanced Diagnostic Laboratory Test status for the firm’s Envisia Genomic Classifier. For the six months beginning Oct. 1 and ending Mar. 31, 2021, Veracyte will collect private-payor payment rate data for the test, which CMS will use the median of to determine the Medicare pricing beginning July 1, 2021. During this time, Veracyte’s classifier will be reimbursed at a rate of $5,500 for all Medicare patients.

Container fabricator SG Blocks and Grimshaw, aarchitecture, planning, and industrial design firm, this week announced plans to build modular coronavirus testing centers for Los Angeles International Airport that they plan to deliver by Nov. 1. The partners D-Tec 2 model testing pods will house CLIA-certified laboratories and use South Korea-based Osang Healthcare's GeneFinder test to provide COVID-19 test results in two hours, according to SG BlocksThe testing pods use restored shipping containers no longer in use. Clarity Mobile Venture, a joint venture involving SG Blocks and Clarity Labswill operate and provide staff for the laboratory. 

The GeneFinder SARS-CoV-2 PCR test is available under a US Food and Drug Administration Emergency Use AuthorizationEarlier this year, SG Blocks announced that it had inked a one-year, non-exclusive distribution agreement with Osang for its GeneFinder COVID-19 Plus RealAmp Kit in the US.

Yourgene Health said this week that the German national reimbursement authority, G-BA, has approved reimbursement for dihydropyrimidine dehydrogenase (DPD) deficiency testing in Germany. Starting in October, preliminary reimbursement for DPD testing will be €120 ($140). It will cover the company's Elucigene DPYD test, a genotyping assay to identify cancer patients with DPD deficiency, which can cause severe or lethal side effects in patients treated with 5-fluorouracil.

Bionano Genomics said this week that German clinical diagnostic service provider MVZ Martinsried has received accreditation in Germany from the accreditation body DAkkS for several laboratory developed tests that run on Bionano's Saphyr optical genome mapping platform. MVZ will be able to use the tests as part of its routine diagnostic workflow to detect genomic translocations, inversions, and duplications.

Caris Life Sciences said this week that the University of Texas Southwestern Medical Center has joined Caris' Precision Oncology Alliance, a collaborative network of cancer centers working to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology. The Harold C. Simmons Comprehensive Cancer Center at UT Southwestern is the only NCI-designated comprehensive cancer center in North Texas and one of only five in the entire Southwest USCaris said. 

Through the Caris Precision Oncology Alliance, UT Southwestern will partner with other cancer centers and academic institutions to broaden patient access to precision cancer care, will have early access to Caris Molecular Artificial Intelligence offerings, and will help establish evidence-based standards for cancer profiling and molecular testing in oncology. The alliance now comprises more than 40 academic, hospital, and community-based cancer institutions, including 16 NCI-designated Comprehensive Cancer Centers.

RenalytixAI said this week that it has received a California Clinical Laboratory License from the California Department of Health for its clinical laboratory in Salt Lake City, Utah. Clinicians can now use the firm’s KidneyIntelX assay to report risk assessment of progressive decline in kidney function in patients with early-stage diabetic kidney disease. The firm is now licensed to provide the assay’s testing services in 49 states.

Biocept said this week that it has regained compliance with the Nasdaq's minimum bid price continued listing requirement. The company was notified a year ago that it wasn't in compliance with the requirement because its common stock failed to maintain a minimum bid price of $1 for 30 consecutive business days. The liquid biopsy firm completed a 1-for-10 reverse stock split earlier this month, after which it was able to regain compliance by maintaining the required minimum closing bid price for 10 consecutive trading days.

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.