PEB - Pacific Edge Ltd

[mr optimistic]

Haha. FDA is supreme rule. Not only in the US but globally. The clear opportunity for PEB is get through all this BS and get people using it. It will never replace the more invasive test to confirm the cancer exists, but the easy opportunity is as a post treatment test once a baseline is confirmed. Unfortunately the demographics of most bladder cancer patients isnt great. Chances are they havent lived a very healthy life and following the simple rules of peeing in a jar and sending it back to the lab are not high. But, it is still a big opportunity to own this process. The disruptive replacement of the current extremely expensive invasive diagnostic go to market plan failed, time to re-think. Dave Darling was good at raising cash, but his ego got in the way of thinking laterally.

[Roskat]

Novitas Publishes Transcript for 8/11 Onco LCD Open Meeting; I Summarize All 21 Speeches

Much ink has been spilled, from here to Genomeweb and elsewhere, about a literally massive (and confusing) new LCD and billing article that Novitas is attempting to roll out for oncology-related tests.A 44-signature public comment letter by ACLA and others has been released.NEW NEWS: HUGE TRANSCRIPT PUBLISHEDThey've posted the transcript of the August 11, 2023 public comment meeting

9 PACIFIC EDGE SHOSKES
Dr. Daniel Shoskes, Senior Medical Director at Pacific Edge Diagnostics, discussed the Local Coverage Determination (LCD) for diagnostic laboratory tests, specifically focusing on the Cxbladder family of tests. He emphasized the importance of correctly characterizing these tests, their purpose, and their role in evaluating and managing hematuria and non-muscle invasive bladder cancer.

Dr. Shoskes explained that the Cxbladder Triage and Detect tests are designed to address the need for cystoscopy in patients with hematuria. Since a vast majority of patients undergoing cystoscopy do not have bladder cancer, these genomic tests are intended to have a high negative predictive value and rule out patients at low risk of urothelial cancer. This approach can significantly reduce unnecessary cystoscopies, resulting in fewer complications, cost savings, and less environmental impact.
He clarified that Cxbladder is not intended to identify other types of cancer, as its sole purpose is to rule out bladder cancer, which is the focus of the AUA guidelines for hematuria workup.
Dr. Shoskes responded to criticisms in the LCD, addressing issues related to false positives, company funding, the inclusion of tests in development, the male bias in study populations, and the need for long-term follow-up. He argued that Cxbladder tests serve their intended purpose effectively and that company sponsorship is a standard practice in the industry.
In conclusion, Dr. Shoskes recommended that Cxbladder Triage and Detect be removed from the scope of the LCD, that Cxbladder Monitor retains coverage due to its utility in the Medicare population, and that references to tests not commercially available be removed from the LCD. He emphasized that restricting access to these tests could lead to more unnecessary cystoscopy procedures, increased patient morbidity, higher costs, and wasted resources, without benefiting patients.

[Roskat]

AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.

Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.

[Mel]

AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.

Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.

Thanks for these posts, it illustrates the perspective that PEB is taking on the issue of the coverage determination - the conclusion by Novita is difficult to call IMHO.

[Sideshow Bob]

https://www.nzx.com/announcements/419755

11/10/2023, 9:23 amGENERALQ4 24 - CXBLADDER TEST VOLUMES RESILIENT IN THE FACE OF HEADWINDS

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) announces test volumes processed at its laboratories in the second quarter of the 2024 financial year (Q2 24) fell 12% to 8,525 from 9,704 in the prior quarter (Q1 24) amid the reorganization of our US operations and publicity on the Medicare coverage determinations.

However, the volume of tests processed in Q2 24 represents an 8% increase on the 7,864 tests processed in the same quarter of the prior year (Q2 23). The reorganization, detailed in the company’s Q1 24 investor update also released today, weighed on sales activity in August and early September.

Meanwhile, volumes were also impacted by some uncertainty among physicians and healthcare providers over Cxbladder’s coverage status following the Medicare non-coverage determination in June by Novitas and then its July withdrawal. These effects were exacerbated by the normal July holiday season lull.

Tests processed in our US laboratory were 7,335 tests in Q2 24, a 15% decrease on the 8,627 tests in Q1 24. The figure represents a 9% increase on the 6,699 tests processed in Q2 23. The number of unique ordering clinicians in the US fell 7% through the quarter to 1,147 but is up 17.3% on the 978 clinicians who ordered tests in Q2 23.

Asia Pacific volumes in Q2 24 were 1,190 up 10% on the 1,077 tests processed in Q1 24, and up 2% on the 1,165 tests processed in Q2 23 with the quarter-on-quarter increase largely reflecting an increase in test volumes associated with clinical studies in the region.

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.

[Roskat]

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.

The provided white paper by Bruce Quinn discusses the FDA's proposal to regulate laboratory-developed tests (LDTs) in the United States. It presents several key features and messages:
Overview of the FDA Proposal: The FDA introduced a comprehensive plan to regulate LDTs on September 29, 2023. The FDA proposal aims to bring LDTs under the same regulatory framework as other medical devices, including registration, reporting, and labeling requirements.
Enormous Costs: The paper emphasizes the staggering costs associated with the FDA's plan, estimating it to be around $50 billion over the first few years. This financial burden on the industry is seen as practically unattainable and far exceeding the annual profits of major diagnostic companies.
Timeline Challenges: The FDA's proposed timeline for implementation is considered unrealistic. The transition from a relatively unregulated LDT environment to full compliance with FDA regulations, including submission of 510(k) and PMA applications, within a few years is evaluated as logistically impossible.
Health Benefits: The FDA claims that its proposal will result in significant health benefits, primarily by improving the accuracy of diagnoses and reducing errors associated with LDTs. However, the paper questions the validity of these claims and suggests that they are speculative.
Legal Considerations: The paper highlights the legal controversy surrounding the FDA's authority to regulate LDTs. While the FDA asserts its legal authority, it acknowledges that this is a disputed claim, as demonstrated by the multiplex legal arguments presented in the paper.
Alternative Solutions: Instead of implementing a sweeping regulatory overhaul, the paper suggests alternative solutions achieving the same goals at far less cost. These include:
1) Addressing accuracy by requiring reviews of LDTs at the current "New York State" level, and
2) Addressing concerns about misleading healthcare claims through far less costly means than the FDA's proposed regulations.
Challenges Ahead: The paper concludes that the FDA's proposal, as outlined, faces significant challenges, including industry opposition, legal disputes, and logistical hurdles. It questions the feasibility of executing the plan in its current form.
In summary, the white paper highlights the immense financial burden and practical challenges associated with the FDA's proposal to regulate LDTs. It questions the speculative health benefits cited by the FDA and suggests that more targeted and cost-effective solutions might be more appropriate. Additionally, it underscores the legal controversy surrounding the FDA's authority in this matter. Overall, the paper presents a critical analysis of the FDA's plan, raising doubts about its feasibility and potential impact.



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[winner69]

Interim results Nov 23 ….they’ll rave about great sales and we’ll find how much cash left in kitty

[Roskat]

AGENCY:

Food and Drug Administration, HHS.
ACTION:

Proposed rule.
SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

[whatsup]

AGENCY:

Food and Drug Administration, HHS.
ACTION:

Proposed rule.
SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

So in a few words how does this effect PEB ?

[Roskat]

So in a few words how does this effect PEB ?

Hi whatsup. Just an incite into the FDA thinking at the moment re lab testing really.