NEW YORK – The UK National Institute for Health and Care Excellence (NICE) this week recommended the use of fecal immunochemical tests to guide referrals of patients suspected of having colorectal cancer. The recommendation, which covers a variety of patients, follows similar recommendations from its diagnostic advisory committee in July, and is being made to reduce the number of unnecessary colonoscopies, NICE said.
The federal Defense Health Agency announced this week a five-year extension of the Laboratory Developed Tests demonstration from July 19, 2023, through July 18, 2028. Anyone currently covered by the military health system TRICARE will continue to have access to certain LDTs. Additionally, the DHA said that TRICARE will now cover several preconception and prenatal carrier screening tests, which previously had been offered through the demonstration, as part of the basic TRICARE benefit. LDTs now covered by TRICARE include tests for cystic fibrosis, spinal muscular atrophy, fragile X syndrome, Tay-Sachs disease, hemoglobinopathies, and conditions linked with Ashkenazi Jewish descent. TRICARE is retroactively covering the tests as screenings back to Dec. 27, 2021, and will cover one test per condition per lifetime, the DHA said.
MDxHealth this week reported that its revenues for the first half of 2023 more than doubled to $31.4 million from $13.0 million a year ago. For the second quarter, the company, which has offices in Irvine, California, and Herstal, Belgium, posted $16.7 million in revenues compared to $6.9 million a year ago. H1 2023 revenues were comprised of $14.0 million from the Oncotype DX GPS prostate cancer testing business, $12.4 million from the Confirm mdx business, $3.7 million from the Resolve mdx business, and the rest from the Select MDx and other businesses. MDxHealth had a net loss of $22.3 million, or $.08 per share, in Q2 2023 compared to a net loss of $18.1 million, or $.12 per share, a year ago. The firm attributed the wider loss in the recently completed quarter mainly to increased expenses. It had $39.5 million in cash and cash equivalents as of June 30.
Bionano Genomics has regained compliance with Nasdaq's minimum bid price requirement this week. The company said it received a notification letter from the Nasdaq Stock Market, stating the closing bid price of the company common stock has been at $1.00 per share or greater for the last 10 consecutive business days, from Aug. 7 to Aug. 18. Bionano was previously notified by Nasdaq in May that the company was not in compliance with the minimum bid price requirement.
Devyser Diagnostics, a developer of genetic testing products for the hereditary disease, oncology, and transplant fields, this week said that its second quarter sales grew 22 percent to SEK 37.7 million ($3.4 million) from SEK 30.9 million a year ago. On a currency neutral basis, sales were up 13 percent year over year, the Swedish firm said. It had a total comprehensive loss of SEK 13.5 million, or SEK .90 per share, for the recently completed quarter compared to a total comprehensive loss of SEK 14 million, or SEK .90 per share, a year ago. Devyser had SEK 303.0 million in cash and cash equivalents at the end of Q2 2023.
Gradientech announced this week that its second quarter earnings were SEK 1.1 million ($103,845) compared to SEK 4,000 in the year-ago period, attributed to sales of the firm's QuickMIC instrument and consumables. In July, the QuickMIC system was granted breakthrough device designation from the US Food and Drug Administration. Gradientech posted a net loss of SEK 16.8 million, or SEK .95 per share, compared to a net loss of SEK 17.7 million, or SEK 1.11 per share, in Q2 2022. The firm ended the quarter with approximately SEK 40 million in cash and cash equivalents.
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.