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In Brief This Week: Novogene, GeneNews, Positive ID, Novosanis, and More.

NEW YORK (360Dx) – Novogene said that its next-generation sequencing medical lab in Tianjin, China, has received accreditation from the College of American Pathologists enabling it to provide clinical sequencing services to customers worldwide.

The firm noted that it recently launched the first NGS tumor gene-detection kit cleared by the China Food and Drug Administration.

Novogene CEO Ruiqiang Li said in a statement that with CAP accreditation, its Tianjin medical center can provide clinical services to more than 450 hospital customers and pharmaceutical partners globally "for projects of any scale, in ways that we could not before.”

In a separate announcement this week, Novogene said that it has ordered 25 Illumina NovaSeq 6000 sequencers. Five of the sequencers will be in the US. In addition, Novogene will operate 20 units purchased by Nanjing Yangzi state-owned investment Group in China.

With the addition of these new NovaSeq sequencers to its existing array of 30 Illumina HiSeq X and 10 PacBio Sequel systems, Novogene said that it now offers the largest and most advanced sequencing capacity in the world with an annual throughput of 280,000 human whole genomes.

GeneNews reported Q4 2016 revenues of $286,000, compared to no revenues in the same period in 2015.

The firm reported Q4 2016 net income of $1.0 million, or $0.02 per share, against a net loss of $1.5 million, or a loss of $0.02 per share, for the same period in 2015.

Its Q4 SG&A expenses were $547,000, down 25 percent from $730,000 in the prior-year quarter.

For the year ending December 31, 2016, the firm reported revenues of $1.0 million, up 207 percent from $325,806 in 2015. It's net loss for the year narrowed slightly to $5.9 million, or a loss of $0.09 per share, from $6.0 million, or a loss of $0.11 per share in 2015.

The firm's 2016 SG&A expenses were $3.8 million, up 21 percent from $3.2 million in 2015.

GeneNews had cash and cash equivalents of $213,843 at the end of 2016.

PositiveID said this week that its 2016 revenues increased 89 percent year over year to $5.6 million from $2.9 million. The revenue increase was attributable to the company's acquisitions of E-N-G Mobile Systems and Thermomedics, which markets the Caregiver noncontact thermometer, in December 2015. PositiveID's molecular diagnostics segment, consisting of its Firefly Dx prototype system, generated revenues of $115,000, all of which was from a US government contract. The company reported a net loss attributable to common stockholders of $13.1 million, or a loss per share of $.06, compared to a net loss of $11.5 million, or a loss per share of $1.88 a year ago. The company used approximately 236.7 million shares to calculate loss per share in 2016 compared to about 6.1 million shares in 2015.

Novosanis said that it received a €200,000 grant from Interreg CrossCare to build the next-generation Colli-Pee self-sampling device suited for home-based urine collection for online sexually transmitted infection testing platforms.

Novosanis would build the device in collaboration with Happy Aging of Belgium, and EIZT of the Netherlands that's optimized for postal delivery to certified laboratories with access to multiple validated STI tests.

The device allows for standardized collection of the first 20ml of the urine stream, or first-void urine, in which STIs — including Chlamydia trachomatis, Neisseiria gonorrea, Mycoplasma genitalium, and Trichomonas — can be detected.

Veracyte said this week that researchers external to the firm presented multiple studies supporting the use of the company's Afirma Gene Expression Classifier in thyroid cancer diagnosis, at Endo 2017, the annual conference of The Endocrine Society, in Orlando, Florida.

Researchers reported finding that use of the Afirma GEC supports current recommendations for managing patients with thyroid nodules designated as "noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP)," the firm said.

This relatively recent pathology designation is intended to consolidate a group of thyroid tumors that have a good outcome provided they are surgically removed, Veracyte said. Using a comprehensive bio-repository of thyroid nodule samples with paired cytology, genomic testing, and histopathology results, the authors found that the Afirma GEC preoperatively identified 24 of 25, or 96 percent of, nodules that turned out to be NIFTP as "suspicious." This designation helps physicians guide patients with "suspicious" Afirma GEC results to surgery, the firm added.

CareDx said in a filing with the US Securities and Exchange Commission that it is unable to file its annual report on Form 10-K for its fiscal year ended December 31, 2016 "without unreasonable effort and expense." The firm said that it needs additional time to complete its annual goodwill impairment analysis and final review of its financial statements and other disclosures in the Form 10-K.

Myriad Genetics said this week that it has published a third clinical validation study and second clinical utility study for its myPath Melanoma test, and thereby completed the reimbursement dossier for the product.

The firm also said that it will submit the reimbursement dossier to Medicare and private insurers three months earlier than expected. 

myPath Melanoma is an objective genetic test that measures 23 genes to help differentiate malignant melanoma from benign lesions.

The Clinical and Laboratory Standards Institute said that it has published a revised edition of its annual supplement that provides revised breakpoints, new testing recommendations, and reporting changes needed to incorporate into routine practice for improved detection and reporting of antimicrobial resistance.

The document, Performance Standards for Antimicrobial Susceptibility Testing (M100, 27th ed.), includes multiple updates that clarify AST recommendations, and three new recommendations that are "really critical for detecting resistance in two of the Centers for Disease Control and Prevention’s urgent antibiotic resistance threats: carbapenemase-producing Enterobacteriaceae and drug-resistant Neisseria gonorrhoeae,” Jean Patel, chairholder of the subcommittee on antimicrobial susceptibility testing, said in a statement.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the 360Dx site.