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In Brief This Week: IVDR, Personalis, DermTech, BGI Genomics, Bionano Genomics, More

NEW YORK – The Council of the European Union last week approved the extension of certain deadlines of the In Vitro Diagnostic Regulation. It also approved extending the deadline by which diagnostic test developers would need to supply data about their tests to the Eudamed medical database. In January, the European Commission proposed giving companies more time to apply the IVDR under certain circumstances after finding a "considerable number" of IVDs on the EU market don't meet the new rules, which began rolling out in 2022. In particular, the situation is "critical" for high-risk IVDs, the EC said. The deadlines to comply with the IVDR were May 26, 2025, for high-risk IVDs and May 26, 2027, for lower-risk IVDs. The new proposal pushes those deadlines to December 2027 for high individual and public health risk devices, December 2028 for high individual and moderate public health risk devices, and December 2029 for lower-risk devices. The proposal also pushes the deadline by which test and device manufacturers will need to upload data about their devices to Eudamed to late 2025 from 2026. The European Parliament is expected to vote on the Commission's plan in April. 

Personalis this week reported an 18 percent year-over-year increase in Q4 revenues, in line with preliminary results reported last month. For the quarter ended Dec. 31, the company booked $19.7 million in revenues, up from $16.7 million during the same quarter in 2022. Pharma tests and services revenues were $11.5 million, enterprise sales (payments from Natera) were $7.1 million, population sequencing revenues from the Million Veteran Program were $1.0 million, and other revenues were $104,000. Q4 net loss totaled $26.6 million, or $.54 per share, down from $31.1 million, or $.67 per share. 

For full-year 2023, Personalis reported $73.5 million in revenues, up 13 percent from $65.0 million in 2022 and in line with expectations. Pharma tests and services revenues were $31.9 million, enterprise sales were $31.7 million, population sequencing revenues were $9.4 million, and other revenues were $436,000. Net loss for the year was $108.3 million, or $2.25 per share, down from a net loss of $113.3 million, or $2.48 per share, in 2022. 

The company ended the year with $57.0 million in cash and cash equivalents and $57.2 million in short-term investments. 

For Q1 2024, Personalis expects revenues ranging from $18.0 million to $19.0 million, including approximately $2.0 million from population sequencing. For full-year 2024, the company anticipates revenues in the range of $73.0 million to $75.0 million, including about $8.0 million from population sequencing. In addition, the firm expects a net loss of approximately $80.0 million in 2024. 

DermTech said this week that its fourth quarter revenues grew 30 percent to $3.9 million from $3.0 million a year ago, as test revenues rose to $3.7 million from $2.7 million, while contract revenues retreated to $222,000 from $302,000. DermTech had a net loss of $19.1 million, or $.56 per share, in Q4 2023 compared to a net loss of $28.2 million, or $.93 per share, a year ago. Its R&D spending dropped 35 percent year over year to $3.3 million from $5.1 million, and its SG&A costs were cut 28 percent to $16.8 million from $23.4 million. 

For full-year 2023, the company recorded $15.3 million in total revenues, a 6 percent increase from $14.5 million in 2022. Test revenues in 2023 rose to $14.4 million from $13.8 million in 2022, while contract revenues grew to $912,000 from $728,000. DermTech's net loss for 2023 was lowered to $100.9 million, or $3.09 per share, from $116.7 million, or $3.88 per share in 2022. It reduced its R&D costs 37 percent to $15.2 million from $24.1 million and trimmed its SG&A spending 6 percent to $88.8 million from $94.8 million. 

The company ended 2023 with $36.7 million in cash and cash equivalents and $19.1 million in short-term marketable securities. 

BGI Genomics said last week that its subsidiary BGI Europe has obtained an extension for its NIFTY noninvasive prenatal testing kit and software under its existing CE-IVDD certification to include the DNBSeq-G99 sequencer. According to the company spokesperson, the CE-IVDD certification has been extended until Dec. 31, 2027. In addition to the G99 platform, the test can also be used on BGISeq-500, DNBSeq-G50, and DNBSeq-G400, all of which are covered by the certificate. 

Bionano Genomics said this week that it has amended the convertible debt financing the company entered into in October 2023 to extend its cash runway. The amendment reduces Bionano’s outstanding debt and provides immediate access to $30.0 million of near-term liquidity. The company also said it will have access to up to an additional $25.0 million of liquidity from the restricted cash account that will now be available as the principal on the notes is retired instead of upon meeting certain funding conditions. 

Bruker said this week it has entered into a definitive share purchase agreement with TecFin, an affiliate of private equity firm PAI Partners, to acquire EliTechGroup for €870 million ($943 million) in cash, excluding the EliTech clinical chemistry business. The deal was originally announced in December. Bruker previously had a put option agreement to acquire EliTechGroup, pending workers' council consultations in France and the Netherlands. The put option has been exercised, and the buyers and sellers have entered into a binding share purchase agreement, Bruker said, adding that the deal is expected to close in the second quarter of 2024. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.