NEW YORK – Thermo Fisher Scientific has made its ImmunoCap Specific IgE tests available to patients at all Kroger Health's The Little Clinic locations in the US this week. To receive the test, patients will undergo a blood draw at the Little Clinic, and the sample will be analyzed at an off-site clinical laboratory. An in vitro allergy diagnostic test with hundreds of whole allergens, allergen mixes, and allergen components, the ImmunoCap Specific IgE test can be performed irrespective of a patient's age, skin condition, medication, disease activity, and pregnancy, Thermo Fisher said.
Danaher announced this week that its board of directors has approved a regular quarterly cash dividend of $.27 per share of its common stock, payable on July 28 to holders of record on June 30.
Accelerate Diagnostics reported this week that its first quarter 2023 net sales declined approximately 7 percent to $2.8 million from $3.0 million in Q1 2022. The firm said the decline was due to lower customer contracting in the quarter but noted that recurring revenues were up 6 percent year over year. Accelerate added three contracted instruments and brought 10 instruments live in the US in the quarter. It ended the first quarter with 338 clinically live and revenue-generating instruments in the US, with another 62 contracted instruments in the process of being implemented in the US and not yet revenue-generating. It also noted that a partnership formed with Becton Dickinson in 2022 has led to a significant increase in quotes and contracts being developed and presented.
Accelerate's net loss for the quarter was $16.8 million, or $.17 per share, compared to a net loss of $13.5 million, or $.20 per share, last year. Research and development costs were $7.0 million, compared to $6.0 million in Q1 2022, related to progress on its next generation instrument, called Wave. SG&A expenses declined to $10.1 million from $10.7 million due to professional fees related to debt restructuring. Accelerate ended the quarter with $29.4 million in cash and cash equivalents and $2.5 million in investments.
DiaCarta this week said that it has received accreditation from the College of American Pathologists for its CLIA-certified laboratory. During the accreditation process, CAP inspectors examine the lab's quality system and records, as well as the laboratory staff's qualifications, laboratory equipment, safety programs, and overall management practices. The accreditation "builds on the success of our recently won New York State CLIA license," VP of Medical Clinical Affairs Zheng Li said in a statement.
Devyser Diagnostics this week reported that its Q1 2023 net sales increased 30 percent to SEK 39.5 million ($3.9 million) from SEK 30.4 million in Q1 2022. Net loss was SEK 19.9 million, or SEK 1.24 per share, compared to a loss of SEK 6.1 million, or SEK .39 per share, in the year-ago period. The Swedish firm ended the quarter with SEK 337.4 million in cash and cash equivalents.
Separately, Devyser also said that its noninvasive fetal RHD test has been approved for marketing in Canada. It is the first Class III IVD product from Devyser approved for sale in that country. The firm added that it has a contract with Héma-Québec, a nonprofit organization that supplies blood products in the province, for the test. The contract is for three years with the possibility of a two-year extension. The potential order value is about SEK 16 million ($1.5 million).
Biocept this week reported a sharp year-over-year drop in Q1 2023 revenues due to declining RT-PCR COVID-19 testing volumes. The San Diego-based company, which stopped COVID-19 testing services in February, reported $673,000 in revenues for the quarter, compared to $20.0 million in Q1 2022. Net loss for the quarter was $7.1 million, or $.41 per share, compared to a net loss of $2.2 million, or $.13 per share, last year. R&D costs totaled $1.0 million in Q1, down from $1.8 million in the year-ago quarter, and SG&A expenses dropped to $3.7 million from $10.0 million a year ago. Biocept ended the quarter with $6.8 million in cash.
Sera Prognostics said this week that its first quarter revenues grew 163 percent year over year. For the three months ended March 31, the Salt Lake City-based maternity and neonatal health company posted $100,000 in revenues compared to $38,000 in Q1 2022. Its net loss contracted to $10.6 million, or $.34 per share, for the recently completed quarter from a net loss of $12.2 million, or $.40 per share, a year ago. Sera's R&D spending rose 24 percent to $4.1 million from $3.3 million a year ago on higher clinical study costs. Its SG&A costs shrank 19 percent to $7.3 million from $9.0 million as the firm trimmed sales operations and better focused its commercial strategy to respond to market dynamics, it said in a statement. The firm had $27.2 million in cash and cash equivalents and $43.6 million in marketable securities as of March 31.
DermTech this week said it has signed new agreements with a Blues plan in South Carolina and the United Mine Workers of America Health and Retirement Funds. As a result, about 1.7 million members of the Blues plan of South Carolina and 90,000 beneficiaries of UMWA Funds will have access to the company's DermTech Melanoma Test. The deal took effect April 1. The RT-PCR-based test is for assessing skin lesions, moles, or dark skin spots for melanoma.
Oncocyte said this week that its Q1 2023 revenues were down about 50 percent year over year, or 22 percent discounting contributions from the DetermaRx assay that the firm jettisoned last December. The company reported $297,000 in non-DetermaRx revenues, compared to $380,000 in the same period of 2022. During a call with investors, company CFO Anish John said he is resigning his role effective June 15.
Overall, Oncocyte had a net income of $3.0 million, or $.02 per share, for the quarter, compared to a loss of $10.3 million, or $.11 per share, in the prior-year quarter. The firm's R&D expenses decreased 45 percent year over year to $2.8 million from $5.1 million, primarily due to a decrease in CLIA laboratory expenses and focused product development spend. Its SG&A expenses were $6.5 million, down 27 percent from $8.9 million. Oncocyte ended the quarter with cash, cash equivalents, and marketable securities of $12.4 million.
Biodesix said this week that its first quarter revenues grew 40 percent to $9.1 million from $6.5 million a year ago. COVID-19-related revenues fell to $13,000 from $984,000 in Q1 2022, while lung diagnostics revenues grew to $8.6 million from $4.6 million. Diagnostic testing revenues for the recently completed quarter were $8.6 million compared to $5.6 million a year ago, and biopharma service revenues were $411,000 compared to $915,000. The Boulder, Colorado-based cancer diagnostics firm had a net loss of $18.7 million, or $.24 per share, in Q1 2023 compared to a net loss of $15.6 million, or $.50 per share, a year ago. Its R&D costs inched up to $3.3 million from $3.2 million, while its SG&A costs rose to $19.0 million from $14.5 million. The company ended Q1 2023 with $25.3 million in cash and cash equivalents. For full-year 2023, Biodesix reaffirmed its prior revenue guidance of between $52 million and $55 million.
Co-Diagnostics reported a precipitous year-over-year drop in first quarter revenues this week, caused by an expected reduction in demand for its Logix Smart COVID-19 test. For the quarter ended March 31, the Salt Lake City-based molecular diagnostics firm posted $602,000 in revenues, down from $22.7 million in the prior-year quarter. CEO Dwight Egan said in a statement that Co-Diagnostics plans to submit its Co-Dx PCR Home platform to the US Food and Drug Administration by the end of this year and to commence clinical trials for its ABC+RSV tests, both for clinical labs and on the new platform, during the next flu season. Net loss for the quarter amounted to $5.8 million, or $.20 per share, compared to net income of $11.7 million, or $.34 per share, in Q1 2022. R&D expenses for Q1 fell to $5.0 million from $3.8 million a year ago while SG&A expenses declined to $4.7 million from $5.6 million. The company ended the quarter with $6.4 million in cash and $68.9 million in marketable securities.
ProPhase Labs this week reported a sharp downturn in Q1 revenues due to reduced COVID-19 testing volumes. For the period ended March 31, the Garden City, New York-based genomics and diagnostics company booked $19.3 million in revenues, a 60 percent reduction from $47.5 million in Q1 2022. The decrease was caused by a $30.4 million decline in COVID-19 testing revenues, offset by a $2.2 million increase in consumer products. Net income for the quarter was $550,000, or $.03 per share, down from $12.5 million, or $.68 per share, a year ago. R&D costs totaled $144,000 in Q1, up from $35,000 a year earlier, and general and administration expenses came to $8.3 million, up from $7.8 million in the year-ago quarter. ProPhase Labs ended Q1 with $9.6 million in cash and cash equivalents and $5.9 million in marketable securities.
Point-of-care test maker Talis Biomedical reported this week that its first quarter revenues declined 63 percent to $1.2 million from $3.2 million a year earlier. Product revenues declined 94 percent to about $137,000 from $2.3 million in the year-ago quarter, while grant revenues were up 26 percent to $1.1 million from $874,000. The firm posted a net loss of $17.8 million, or $.66 per share, compared to a net loss of $33.0 million, or $1.25 per share, a year earlier. Its R&D costs were $13.8 million, down from $20.7 million in the year-ago quarter. Its SG&A costs were trimmed to $6.4 million from $11.9 million. Talis ended the quarter with $113 million in cash and cash equivalents and $1.0 million in restricted cash. The company said in a statement it is prioritizing development of four panels for COVID-19 and influenza A and B, herpes simplex virus 1 and 2, vaginal infections, and chlamydia, gonorrhea, and trichomonas vaginalis.
Miami-based, at-home diagnostic collection firm Getlabs said this week that it is partnering with Sana MD, enabling its patients to access Getlabs' network of phlebotomists. After receiving a lab order from a Sana MD primary care provider, patients will have the option to have a Getlabs visit scheduled to collect blood or other specimens at home for laboratory testing. Sana offers health plans to small businesses in 10 states. Last week, Getlabs announced a deal to provide its services to Nice Healthcare.
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.