Triage Plus Price Set To Lift Pacific Edge's Economics
Pacific Edge notes today that the draft 'Gapfill' prices for Cxbladder Triage Plus2 have been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of US$1,018.44.
When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test.
In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026.
Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication.
Pacific Edge Chief Executive Dr Peter Meintjes said: 'We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.
'The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.'
Notes:
1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+.
3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not.
4 Half year to 30 September 2024.
5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.
6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126.
7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Otago Daily Times
2 days ago
- Otago Daily Times
Pacific Edge raises $16m in share sale
Pacific Edge has raised $16 million in new equity in a placement of new ordinary shares — $1m more than it sought — after accepting over-subscriptions. On Friday, the cancer diagnostics company announced a $20m capital raise, saying it was about ensuring it had the cash reserves to capitalise on recent clinical and commercial milestones, grow in non-Medicare channels in the United States and regain Medicare coverage of its tests. It comprised a placement of $15m of new ordinary shares offered to selected investors and an offer of $5m of new shares to retail investors, by way of a share-purchase plan. The share issue was priced at $0.10 per share. Yesterday, the company said the placement — which was well-supported by existing shareholders — was completed on Friday and was subject to shareholder approval. It was now targeting the opening of a $5m offer to eligible retail investors at the same per share offer price in July or early August, with the ability to accept oversubscriptions. In a statement to the NZX, chairman Chris Gallaher said the company was delighted with the investor support it had received. The inclusion of Cxbladder in the American Urological Association's (AUA) new microhematuria guideline in February was significant and had allowed the company to view the non-coverage determination differently. "We are leveraging the important AUA guideline to build on the commercial momentum we have already established, including our plans to regain Medicare coverage," he said. Medicare coverage of the company's tests ceased after the Local Coverage Determination (LCD) became effective on April 24. In a note on Pacific Edge's FY25 financial result also released on Friday, Forsyth Barr analysts described it as "relatively uneventful". Revenue was consistent with the firm's expectations and costs were slightly higher than expected. Despite Pacific Edge being adamant for some time it had sufficient cash resources to navigate the LCD uncertainty, the analysts were not surprised by the capital raise. It was the company's 11th equity raise since 2003 — cumulative raises totalled more than $260m — which would take its share count to more than 1billion from just under 10million in 2004. Post-raise, its cash balance would be about $38m ($22.6 million at FY25) and the analysts estimated that was 16 to 18 months of cash on hand. "While this is a supportive lifeline, even in the event of [Medicare] recoverage, we aren't convinced this is the last of PEB's raises," they said. s
Scoop
3 days ago
- Scoop
Pacific Edge Placement Upsized To NZ$16 Million
Press Release – Pacific Edge Pacific Edge is now targeting the opening of a NZ$5 million offer to eligible retail investors by way of a Share Purchase Plan (SPP) at the same NZ$0.10 cents per share offer price in July or early August 2025 (with the ability to accept oversubscriptions). Note: PEB has released this update to the NZX and ASX as per listing rules.1* Pacific Edge today announces it has successfully raised NZ$16 million of new equity in a placement of new ordinary shares (Placement) — NZ$1 million more than it sought — after Directors resolved to accept over subscriptions.2* The Placement, which was well supported by existing shareholders, was completed on Friday 30 May 2025 and is subject to shareholder approval.3* It was priced at NZ$0.10 cents per share, a premium to the 20-day volume average weighted price (VWAP) prior to the announcement of the company's planned ~NZ$20 million equity issue. Pacific Edge is now targeting the opening of a NZ$5 million offer to eligible retail investors by way of a Share Purchase Plan (SPP) at the same NZ$0.10 cents per share offer price in July or early August 2025 (with the ability to accept oversubscriptions).4 A shareholder meeting to approve the Placement is planned for late July or early August 2025. The Placement and the planned SPP are aimed at ensuring Pacific Edge has additional resources and capacity to capitalize on its recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage of its tests. Medicare coverage of the company's tests ceased after the 'Genetic testing for Oncology; Specific Tests' (L39365) Local Coverage Determination became effective on 24 April 2025. Chairman Chris Gallaher said: 'We are delighted with the investor support we have received. The inclusion of Cxbladder in the American Urological Association's (AUA) new microhematuria guideline in February 2025 is significant and has allowed the company to view the non-coverage determination differently. We are leveraging the important AUA guideline to build on the commercial momentum we have already established, including our plans to regain Medicare coverage.' Pacific Edge Chief Executive Dr Peter Meintjes said: 'The robust evidence emerging from our clinical evidence program is shifting clinical sentiment towards the broader adoption of our tests in the US and further afield and represents a significant opportunity in addition to Medicare re-coverage. We are delighted with the strong support we have received from investors to continue to pursue our plans, and we are looking forward to making the same offer to the remainder of our shareholders via the SPP.' Pacific Edge is advised on the equity raise by Cameron Partners (investment banking advisers), Harmos Horton Lusk (legal advisers) and The Project (investor relations and communications advisers). For further information on the detail and timetable of the equity raising please refer to the announcement and presentation dated Thursday 29 May 2025 and released by NZX and ASX on Friday 30 May 2025. Footnote: 1* PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2* Shareholder approval is required to settle the Placement (i.e., for payment for, and allotment of, the new shares offered under the Placement) given the Placement exceeds Pacific Edge's placement capacity (15% of Pacific Edge's current shares on issue) and due to Related Party participation. The Placement is also conditional on all necessary regulatory approvals. In this regard, the company intends to seek a waiver from NZX Listing Rule 4.19.1 to permit the allotment of shares under the Placement after shareholder approval is obtained. The Placement offer closed on 30 May 2025 for the purposes of clause 21(1)(b)(ii) of Schedule 8 to the Financial Markets Conduct Regulations 2014. 3* See footnote 1. 4* No offer of new shares is made under the SPP unless and until Pacific Edge sends the SPP offer document to shareholders. No money is currently being sought, and new shares cannot currently be applied for or acquired, under the SPP.
Scoop
3 days ago
- Scoop
Pacific Edge Placement Upsized To NZ$16 Million
Note: PEB has released this update to the NZX and ASX as per listing rules.1* Pacific Edge today announces it has successfully raised NZ$16 million of new equity in a placement of new ordinary shares (Placement) — NZ$1 million more than it sought — after Directors resolved to accept over subscriptions.2* The Placement, which was well supported by existing shareholders, was completed on Friday 30 May 2025 and is subject to shareholder approval.3* It was priced at NZ$0.10 cents per share, a premium to the 20-day volume average weighted price (VWAP) prior to the announcement of the company's planned ~NZ$20 million equity issue. Pacific Edge is now targeting the opening of a NZ$5 million offer to eligible retail investors by way of a Share Purchase Plan (SPP) at the same NZ$0.10 cents per share offer price in July or early August 2025 (with the ability to accept oversubscriptions).4 A shareholder meeting to approve the Placement is planned for late July or early August 2025. The Placement and the planned SPP are aimed at ensuring Pacific Edge has additional resources and capacity to capitalize on its recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage of its tests. Medicare coverage of the company's tests ceased after the 'Genetic testing for Oncology; Specific Tests' (L39365) Local Coverage Determination became effective on 24 April 2025. Chairman Chris Gallaher said: 'We are delighted with the investor support we have received. The inclusion of Cxbladder in the American Urological Association's (AUA) new microhematuria guideline in February 2025 is significant and has allowed the company to view the non-coverage determination differently. We are leveraging the important AUA guideline to build on the commercial momentum we have already established, including our plans to regain Medicare coverage.' Pacific Edge Chief Executive Dr Peter Meintjes said: 'The robust evidence emerging from our clinical evidence program is shifting clinical sentiment towards the broader adoption of our tests in the US and further afield and represents a significant opportunity in addition to Medicare re-coverage. We are delighted with the strong support we have received from investors to continue to pursue our plans, and we are looking forward to making the same offer to the remainder of our shareholders via the SPP.' Pacific Edge is advised on the equity raise by Cameron Partners (investment banking advisers), Harmos Horton Lusk (legal advisers) and The Project (investor relations and communications advisers). For further information on the detail and timetable of the equity raising please refer to the announcement and presentation dated Thursday 29 May 2025 and released by NZX and ASX on Friday 30 May 2025. Footnote: 1* PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2* Shareholder approval is required to settle the Placement (i.e., for payment for, and allotment of, the new shares offered under the Placement) given the Placement exceeds Pacific Edge's placement capacity (15% of Pacific Edge's current shares on issue) and due to Related Party participation. The Placement is also conditional on all necessary regulatory approvals. In this regard, the company intends to seek a waiver from NZX Listing Rule 4.19.1 to permit the allotment of shares under the Placement after shareholder approval is obtained. The Placement offer closed on 30 May 2025 for the purposes of clause 21(1)(b)(ii) of Schedule 8 to the Financial Markets Conduct Regulations 2014. 3* See footnote 1. 4* No offer of new shares is made under the SPP unless and until Pacific Edge sends the SPP offer document to shareholders. No money is currently being sought, and new shares cannot currently be applied for or acquired, under the SPP.
