NEW YORK (360Dx) – Ambry Genetics, a Konica Minolta company, said this week that it is collaborating with the National Institutes of Health-funded Undiagnosed Diseases Network to "facilitate transition" of patients with negative or uncertain test results to the UDN in hopes of providing them with answers. Ambry said it aims to diagnose and better understand disease, including rare and undiagnosed disorders, through its "Finding Answers" program, which uses the company's exome-based genetic testing. The collaboration with the UDN complements this program because "it's another promising avenue to answers that undiagnosed patients and their clinicians so desperately need," Kelly Hagman, director of clinical genomics for Ambry, added in a statement.
Quotient said this week that its 2019 fiscal third quarter revenues rose 14 percent year over year to $6.7 million from $5.9 million, beating the analysts' average estimate of $6.2 million.
For the three months ended Dec. 31, 2018, the firm reported product sales to original equipment manufacturers of $4.7 million, up 24 percent year over year from $3.8 million. It reported product sales to direct customers and distributors of $2.0 million, up 11 percent year over year from $1.8 million. The firm reported $206,000 in other revenues in fiscal Q3 2018 but none in fiscal Q3 2019.
The firm said that its fiscal Q3 net loss widened to $26.3 million, or $.46 per share, from $20.3 million, or $.47 per share, in the prior-year quarter. Analysts estimated a loss of $.45 per share. Its weighted average shares outstanding for Q3 2019 were 56.6 million and 43.4 million in Q3 2018.
Quotient spent $11.8 million on R&D in fiscal Q3 2019, down 1 percent from $11.9 million in fiscal Q3 2018. Its SG&A expenses were $9.8 million, up 13 percent from $8.7 million in fiscal Q3 2018.
The firm had $107.7 million in cash and other short-term investments as of Dec. 31, 2018.
It guided to between $27.6 million and $27.8 million in revenues for full fiscal year 2019.
Quotient said that in Q3, it continued to experience strong top line growth in its core liquid reagent business.
The firm's CEO Franz Walt said in a statement that it is "well positioned with an ISO certified MosaiQ manufacturing system, a CE-marked MosaiQ instrument, and the resources required to bring a commercializable MosaiQ testing menu to the transfusion diagnostics market."
He said that the firm's "ongoing menu expansion plans are progressing well as evidenced by our first SDS microarray entering its field trial and the development data for our extended antigen panel." When available, an extended antigen panel will replace its initial immunohematology menu.
In December 2018, the firm raised $64.5 million in net proceeds from a public offering of its ordinary shares.
Angle this week announced its unaudited financial results for the six months ended Oct. 31, 2018. The liquid biopsy company reported that revenues increased to £273,000 ($357,000) from £188,000 in H1 2017. The firm's loss for the year widened to £4.1 million from £3.5 million, reflecting planned investments. More than 60,000 blood samples had been processed on an installed base of about 200 Parsortix instruments as of Oct. 31, the company said. Angle had a cash balance of £14.9 million at the end of October.
PathAI announced this week it has received ISO 13485 certification of its quality management system. It also received Medical Device Single Audit Program certification. Together, the designations validate its approach to produce medical device software that is safe and effective to support pathologists and help detect and treat diseases, PathAI said.
C2N Diagnostics announced this week that it has received US Food and Drug Administration breakthrough device designation for its brain amyloidosis blood test for use as a screen for brain amyloid pathology in patients being assessed for Alzheimer's disease. The company also launched its pivotal Plasma Test for Amyloid Risk Screening (PARIS) study to evaluate and validate the clinical diagnostic performance of the test. The blood-based test was developed to predict brain amyloid PET scan results in adults complaining of memory loss or with dementia.
Interpace Diagnostics this week said it has closed its previously announced underwritten public offering of about 9.3 million shares of its common stock at a price of $.75 per share. The firm's gross proceeds from the offering are about $7 million. HC Wainwright acted as the sole book-running manager for the offering.
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