NEW YORK – Quest Diagnostics said this week that it has completed its acquisition of the outreach laboratory services of Maine healthcare system Northern Light Health. Additionally, Quest now provides lab management service for nine of Northern Light Health’s hospital labs as well as for its cancer center laboratory at Norther Light Cancer Care in Brewer, Maine. Quest first announced the deal in December 2022.
Applied DNA Clinical Labs (ADCL), a subsidiary of Applied DNA Technologies, said this week that it has submitted a validation package to the New York State Department of Health (NYSDOH) to support the approval of a pharmacogenomics assay as a NYSDOH laboratory-developed test (LDT). If approved, the LDT test will be used by ADCL to power its population-scale PGx testing services. The company said its commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing. In advance of initiating its PGx testing services, ADCL sales outreach has targeted regional health systems and large, self-insured entities in its New York operating area and in states that recognize New York's CLEP/CLIA certification. ADCL's PGx assay interrogates 120 targets across 37 genes relevant to a broad range of common drugs, including cardiac, pain management, cancer, and mental health therapies, yielding actionable information to enable healthcare providers to deliver personalized drug prescribing and dosing to their patients, the company said.
Point-of-care diagnostics firm Proxim Diagnostics announced this week that it has received a strategic investment from BioMérieux for an undisclosed amount. The funding will be used to complete the development and commercial path of Proxim’s Profile System, a portable immunodiagnostic device that can run multiplex tests with disposable cartridges, the company said in a statement. Proxim is developing immunoassays for sepsis, cardiology, and infectious diseases that can be run using whole blood and plasma. As part of the investment, Andrew Parker, BioMérieux’s head of global business development, has joined Proxim’s board of directors as an observer.
Earlier this month, BioMérieux announced that it had recently acquired an approximately 20 percent stake in Proxim Diagnostics.
Enzo Biochem reported this week that its revenues were down 52 percent in the second fiscal quarter of 2023, to $16.3 million, compared to $34.0 million a year earlier. For the quarter ended Jan. 31, the firm reported a net loss of $11.3 million, or $.23 per share, compared to a net loss of $2.7 million, or $.05 per share, in the year-ago period. Enzo ended the quarter with $5.1 million in cash and cash equivalents. To explain the year-over-year revenue decline, the firm cited softer demand for COVID-19 testing during the most recent quarter and a bulk order received by its life sciences division during the year-ago quarter. Enzo also said this month that it had entered an agreement to sell the assets of its clinical laboratory division to Laboratory Corporation of America for about $146 million in cash.
Exagen this week reported that its fourth quarter revenues rose slightly to $12.8 million from $12.7 million in Q4 2021. Net loss was $14.4 million, or $.83 per share, with $6.7 million coming from goodwill impairment and severance charges, compared to a net loss of $7.1 million, or $.42 per share, in the fourth quarter of 2021. Revenue for full-year 2022 was $45.6 million, down 6 percent from $48.3 million in 2021. Net loss for the year was $47.4 million, or $2.77 per share, compared to a loss of $26.9 million, or $1.68 per share, in 2021. The firm had cash and cash equivalents of approximately $62.4 million as of Dec. 31. Exagen increased its Q1 2023 guidance to be in the range of $9.2 million to $9.7 million, up from the previously forecast range of $8.2 million to $9.2 million.
Trinity Biotech said this week that its revenues for the fourth quarter were down almost 8 percent year over year. For the three months ended Dec. 31, 2022, the Dublin, Ireland-based diagnostics firm posted $18.0 million in revenues, down from $19.5 million in the year-ago period. Clinical laboratory revenues were down 10 percent to $15.4 million from $17.1 million, while point-of-care revenues rose 13 percent to $2.7 million from $2.4 million. The company had a net loss of $10.1 million, or $.27 per share, for the quarter compared to a net loss of $1.3 million, or $.06 per share, in Q4 2021.
For full-year 2022, Trinity Biotech had $74.8 million in revenues, down 20 percent from $93.0 million in 2021. Clinical laboratory revenues dipped 21 percent to $65.6 million from $82.6 million, while point-of-care revenues slipped 11 percent to $9.2 million from $10.3 million. Net loss for 2022 was $41.0 million, or $1.22 per share, compared to a profit of $875,000, or $.04 per share, in 2021.
The company had cash and cash equivalents of $6.6 million as of the end of 2022.
Sera Prognostics said this week that its fourth quarter revenues grew 150 percent year over year. For the three months ended Dec. 31, 2022, the Salt Lake City-based maternal and neonatal diagnostics firm pulled in $65,000 in revenues, up from $26,000 in Q4 2021 but falling short of analysts' average estimate of $140,000. Its net loss for the recently completed quarter was $9.7 million, or $.31 per share, compared to a net loss of $12.5 million, or $.41 per share, a year ago. The consensus Wall Street estimate was a loss of $.37 per share.
For full-year 2022, Sera had $268,000 in revenues, more than three times the $82,000 in revenues in 2021 but short of the consensus Wall Street estimate of $360,000. The firm had net loss of $44.2 million, or $1.43 per share, in 2022 compared to a net loss of $35.0 million, or $2.33 per share, in 2021. Analysts, on average, had estimated a net loss per share of $1.48.
The company used 30,943,426 shares to calculate its 2022 loss per share compared to 15,003,144 shares for its 2021 loss per share.
Sera finished 2022 with $29.9 million in cash and cash equivalents and $52.8 million in marketable securities.
Aspira Women’s Health said this week that its Q4 2022 revenues were up 16 percent year-over-year. For the three months ended Dec. 31, 2022, the Austin, Texas-based women’s diagnostics firm posted $2.2 million in revenues, up from $1.9 million in Q4 2021. Its net loss for the recently completed quarter was $5.1 million, or $.04 per share, compared to a net loss of $9.0 million, or $.08 per share, a year ago.
For full-year 2022, Aspira had $8.01million in revenues, up 23 percent from $6.8 million in 2021. It had a net loss of $27.2 million, or $.23 per share, in 2022 compared to a net loss of $31.7 million, or $.28 per share, in 2021.
Aspira finished 2022 with $13.3 million in cash and cash equivalents.
Alveo Technologies said this week that it has received ISO 13485:2016 certification for its quality management system. Specifically, the certification is for the design, development, and manufacture of in vitro diagnostic kits and analyzers to detect infectious disease, the Alameda, California-based developer of molecular sensing and diagnostics said. Its flagship technology is the rapid, handheld Be.well platform, which leverages molecular assays with cloud-enabled data analytics for real-time disease, pathogen, and contaminant detection, analysis, and diagnosis. Earlier this year, the company signed a memorandum of understanding with the Barbados Investment and Development Corporation to codevelop Be.well with scientists in Barbados for assays in infectious disease, agriculture, veterinary, food, medicine, and aquaculture testing.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.