NEW YORK (360Dx) – Quotient this week said that revenues for its fiscal fourth quarter ended March 31 rose to $6.1 million, up 11 percent year over year from $5.5 million.
The firm's newly-appointed CEO Franz Walt said in a statement that it is making progress in European field trials that began in May for an initial blood grouping immunohematology (IH) microarray. Quotient said that it expects to file for European regulatory approvals for its initial MosaiQ IH microarray in the second half of calendar 2018, and for its initial serological disease screening microarray in the first half of calendar 2019. The firm added that it expects to file for US and European regulatory approval for an expanded IH microarray in the second half of 2019.
Walt said that the firm's MosaiQ platform has the potential to deliver "substantial savings" to its customers by providing walk-away automation and standardized testing workflows, and by permitting the "comprehensive characterization" of all units of donated blood in an affordable manner.
Quotient's net loss for the quarter narrowed to $20.1 million, or a loss of $.44 per share, from $20.3 million, or $.69 per share, in Q4 2017. Its R&D expenses fell to $13.3 million, down 2 percent year over year from $13.6 million, and its SG&A expenses rose to $8.3 million, up 14 percent from $7.3 million.
For the full fiscal year ended March 31, Quotient reported revenues of $24.7 million, up 11 percent year over year from $22.2 million. Its net loss for the year narrowed to $82.3 million, or a loss of $2.02 per share, from $85.1 million, or $3.02 per share, in 2017.
For the full fiscal year, the firm's R&D expenses fell to $51.2 million, down 10 percent year over year from $57.1 million, and its SG&A expenses rose to $33.0 million, up 16 percent from $28.4 million.
At the end of its fiscal fourth quarter, the firm had cash and equivalents of $20.2 million and short-term investments of $5.7 million.
Agilent Technologies announced this week that it has completed its previously announced acquisition of Advanced Analytical Technologies for $250 million in cash. Advanced Analytical's 109 employees will join Agilent as part of the new biomolecular analysis division within its diagnostics and genomics group. The new division will also consist of Agilent's existing microfluidics business.
Agilent also said this week that it has entered into a definitive agreement to acquire all the business assets of Ultra Scientific, a provider of chemical standards and certified reference materials. Ultra Scientific manufactures and supplies certified reference materials, organic and inorganic standards, calibration standards, and IQ/OQ/PQ and quality control check standards. The firm serves the environmental, food, forensics, pharmaceutical, chemical and energy, and academia and government end markets, and Agilent is one of its largest customers. Financial terms were not disclosed.
Laboratory for Advanced Medicine said that it has expanded its existing corporate headquarters in Irvine, California, to include a 10,000-square-foot sequencing lab for R&D, and additional labs to assist in clinical trials for potential US Food and Drug Administration approval of its IvyGene cancer blood tests.
LAM also opened a new office in Dallas to support its sales and marketing team and accommodate inquiries and orders for IvyGene.
The firm announced these initiatives in conjunction with the launch of a laboratory-developed version of IvyGene, which is designed to detect DNA methylation patterns consistent with the presence of cancer and provide quantitative data about the presence of cancer at the time of testing.
Australian multiplexed diagnostics firm AusDiagnostics said this week it has received ISO accreditation for manufacturing of its in vitro diagnostic products in London. All of the company's products had been manufactured in its Sydney headquarters. Since April, the firm's London facility has been ISO 13485-certified and able to manufacture its products, enabling direct delivery to its European customers.
The College of American Pathologists accredited Scottsdale, Arizona-based Advanced Genomic Solutions' genetic testing laboratory in Hong Kong. As part of the accreditation process, CAP inspectors examined the Hong Kong facility’s records and quality control procedures for the preceding two years. They also examined lab staff qualifications, equipment, facilities, the firm's safety program and record, and its overall management.
Quidel said this week that it has entered into separate, privately negotiated exchange agreements with certain holders of its 3.25 percent convertible senior notes due 2020 to exchange about $32.7 million in aggregate principal amount of the 2020 notes for about 927,470 shares of the company’s common stock plus an additional number of newly issued shares of the company’s common stock. The additional number of newly issued shares will be determined based on the volume-weighted average price of the company’s common stock over the three consecutive trading days commencing on June 1. The transactions are expected to close on June 15.
Genomind said this week that it has entered into a partnership with Albertsons Companies to allow pharmacy patients at select Albertsons, Jewel-Osco, and Acme supermarkets to voluntarily receive free education about Genomind's Genecept Assay, a genetic test designed to help clinicians optimize treatment decisions for their patients dealing with mental health issues. At the select locations, specially trained pharmacists may decide to counsel a patient if they see a pattern of the patient having unsuccessful experiences with a medicine prescribed for depression, anxiety, obsessive-compulsive disorder, or other mental illnesses, the firm said. Upon agreement from the patient, the pharmacist could contact the treating clinician, and suggest and then administer the Genecept Assay. The pharmacist would review the results of the genetic test with the patient after its return from Genomind’s CLIA-certified lab. The clinician would receive the test results and could use them to help guide treatment decisions.
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